Dyne Therapeutics is a biotechnology company dedicated to advancing life-changing therapies for patients with serious muscle diseases. Leveraging its expertise in muscle biology, nucleic acid delivery, and gene therapy, Dyne is at the forefront of developing innovative treatments to address unmet medical needs and improve the lives of individuals affected by muscle disorders.

Senior Director, Medical Director

Executive Director, Clinical Development

Senior Director, Clinical Development

Director, Program Management

Director, Medical Science Liaison

SVP, Head of Clinical Development

Associate Director, Clinical Scientist

Director, Scientific and Medical Education

Associate Animal Care Technician

Executive Director, Head of Supply Chain

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; &nbsp; The Head of Managed Markets Account Team will bring their extensive market access experience to our first product launches in neuromuscular disease with an initial focus on launch readiness and commercialization of our lead assets in Duchenne Muscular Dystrophy and myotonic dystrophy Type I (DM1). This individual is responsible for driving and optimizing market access results by building and leading a team focused on commercial and government payers that executes access strategies and cultivates senior stakeholder relationships within target accounts. The Team Lead is responsible for driving new initiatives to provide best-in-class support and minimizing reimbursement as a barrier in order to enhance overall patient access to therapy. Key responsibilities include developing and implementing strategic account plans, negotiating contracts, analyzing financial and utilization data, overseeing compliance, and collaborating with internal teams to align with organizational goals and adapt to evolving healthcare regulations. This individual will play a pivotal role in establishing market access across the books of business (Commercial, Medicaid, etc.) partnering with cross-functional teams to lead the planning and execution of payer engagement strategies and tactics. A successful candidate is a self-starter who is highly driven, collaborative, and embodies values such as bold thinking, agility, and an execution-focus. As part of a high performing team, this role seamlessly collaborates cross functionally to deliver a one Dyne approach, including close collaboration with other field roles, Marketing, Medical Affairs, Patient Services, Global Value and Access, HEOR, and Advocacy, to ensure cohesive and aligned go-to-market strategies and successful execution. This is a unique opportunity for an exceptional strategic thinker and commercial leader to play a key role. This is a remote role. Primary Responsibilities: &nbsp; Design a fit-for-purpose market access organization to enable broad and timely access to Dyne therapies. Build, recruit, and nurture a high-performing team of market access experts. Develop and implement a comprehensive payer engagement strategy to support the launch and lifecycle management of Dyne’s product(s) Develop and execute strategic account plans to identify opportunities for business growth and improved patient access to therapies or services. Eliminate or significantly reduce barriers to access and reimbursement for portfolio of products, inclusive of drug and procedural code coverage.&nbsp; Collaborate with internal and external stakeholders to leverage and implement reimbursement, managed care, payer, and healthcare policies that ensure attainment of business objectives Design and drive Dyne’s development of payer account management/outreach as well as pricing and contracting (as needed) for optimal reimbursement and robust market penetration Establish and strengthen successful business partnerships with external partners and stakeholders, including but not limited to executive management (CEO, CFO, Director of Pharmacy Services, Contracting Directors, State Medicaid officials, and fiscal intermediaries), medical directors, key physicians, and secondary customers (pharmacists, nurses, and other healthcare professionals). Conduct business reviews of key accounts and the marketplace on an agreed-upon, consistent basis. Work closely with Medical Affairs, Global Value and Access and HEOR team members to ensure the creation of a clinical value proposition for Dyne’s products incorporating differentiating and compelling product data to optimize product value Collaborate with cross-functional teams R&amp;D, finance, marketing, sales, and advocacy, and legal to align market access strategies with business objectives Develop and manage departmental budget ensuring efficient allocation of resources to achieve strategic objectives Ensure compliance with corporate policies and procedures, US healthcare laws and regulations Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; BA/BS degree required; advanced degree (MBA, PhD, PharmD) preferred Minimum of 15 years of relevant experience in the pharma/biotech industry across various roles, including market access, account director, payer marketing, sales leadership, and marketing. This experience should demonstrate increasing technical and strategic responsibility or a combination of education and relevant experiences. Minimum of 5 years in a National Payer Account Director/field leadership role Proven track record of successfully launching and commercializing biotech products, with a strong understanding of the unique challenges and opportunities in the rare disease market Deep understanding of market access, market structure, competitive landscape, industry trends, and regulatory environment in the US region required Proven analytical and problem-solving skills. Ability to analyze data, understand trends and develop recommendations for action based on analysis Influential personality with the ability to simplify and clarify complex issues to broad and diverse audiences Enterprise mindset that makes culture and values come to life in everyday activities Experience in a small, rapidly growing biotech with the ability to operate and maneuver in a start-up environment while keeping a solutions-oriented mentality Demonstrates an authentic willingness and capability to roll up sleeves rather than relying on others for delivery Ability to travel to meet business objectives. &nbsp; #LI-BJMA Pay Range$210,000&mdash;$252,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Managed Markets and Patient Support Services Marketing

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Associate Director/Director, Medical Science Liaison (MSL) is an experienced field medical expert who plays a strategic role on the field medical team with depth and breadth of business acumen, therapeutic knowledge and serves as an informal leader on the team. The person in this role will be a customer facing, field-based extension of our Medical Affairs team. The MSL’s key objective is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes. This individual will serve as a key scientific resource, engaging with healthcare professionals (HCPs), key opinion leaders (KOLs), and other stakeholders to provide scientific and clinical support for our portfolio. Primary Responsibilities Include: Builds awareness of the company within the medical community and develops strategic KOL/territory engagement plans aligned with the medical strategy Supports clinical research (investigator-initiated and company-sponsored), speaker development, and training as needed Demonstrates thorough knowledge of the company, its investigational products, and current medical research Maximizes attendance at national and regional conferences to gather insights, assess the competitive landscape, and strengthen relationships Collaborates cross-functionally (clinical, regulatory, market access) to advance business and scientific goals Develops and executes regional medical strategies in alignment with company goals Leads KOL engagement strategies and identifying new scientific leaders Demonstrates business acumen within therapeutic area and understands broader organization and competitive landscape. Establishes and develops HCP relationships, engaging in activities such as data discussions, clinical trials, and addressing patient journey barriers Responds to unsolicited information requests in a timely, accurate, and compliant manner Ensures compliant dissemination of scientific and clinical information to healthcare providers Manages administrative tasks (e.g., Veeva CRM, expense reports, compliance modules) efficiently, including customer profiling and keeping CRM information up to date Education and Skills Requirements: Advanced scientific degree or equivalent required (e.g., MD, PhD, NP, PharmD, PA) 8+ years of MSL experience Clinical experience within neuromuscular disorders (e.g., DMD, DM1) preferred; rare disease experience considered Strong knowledge of investigational products and the neuromuscular space, including emerging data In-depth understanding of clinical trial and investigator-sponsored study processes Proven ability to work effectively within multidisciplinary teams Clear understanding of MSL role and responsibilities Skilled in building and maintaining relationships with KOLs through scientific expertise and follow-through Able to communicate research results clearly to diverse audiences Strong communication skills (written, verbal, presentation) for building relationships with colleagues Expert in planning, prioritizing, and executing tasks efficiently Capable of working independently and managing time in a home office Adaptable in ambiguous and dynamic environments Leverages past neuromuscular relationships to support study enrollment and site communication Experienced in relationship building to expand company reach Experience with relationship building and expanding a company’s reach Must be willing to travel extensively and occasionally on weekends &nbsp; &nbsp; #LI-OnsiteThe pay range displayed below is the range of base pay compensation within which the company expects to pay for this role at the time of this posting. Individual compensation depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.Salary Range$215,000&mdash;$246,000 USDThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director/Director, Medical Science Liaison  - South

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents. This position is responsible for the medical writing activities for one or more clinical programs and will interact with other functions (eg, clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs) as necessary. This position will function with limited supervision as required and ensures deliverables are of high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. Previous experience in authoring and reviewing clinical, nonclinical, and regulatory documents is desired. The ability to lead strategic discussions to ensure aligned messaging throughout regulatory documentation is critical. Outstanding communication skills are a must. This role is based in Waltham, MA with hybrid work flexibility. Primary Responsibilities Include: Writes, edits, and collaborates with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, CTDs, and briefing books Reviews, edits, and ensures quality of documents or sections of documents prepared by functional area representatives as required and ensures adherence to standards Oversees document review comment resolution meetings Contributes to overall project management and to cross-functional working groups as needed to facilitate efficient development and finalization of clinical and regulatory documents for submissions Supports the development of best practices for authoring and reviewing, with a focus on continuous process improvement Education and Skills Requirements: Minimum of a Bachelor’s degree (advanced degree preferred) in Life Sciences, or related discipline, with a solid understanding of the basic principles of biochemistry and molecular biology Minimum 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company Competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents per company and other guidelines Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs) Proficiency with typical office applications (eg, Microsoft Office, Adobe Acrobat) and in shared document systems (eg, SharePoint, Veeva) Ability to work independently: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines Aptitude for compilation, analysis, and presentation of data Ability to work with multiple contributors to produce a final unified document Commitment to accuracy and detail-oriented work &nbsp; &nbsp;The pay range displayed below is the range of base pay compensation within which the company expects to pay for this role at the time of this posting. Individual compensation depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.Salary Range$194,000&mdash;$213,000 USDThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, Medical Writing

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary The Director of Clinical Pharmacology will lead the strategic planning and execution of clinical pharmacology and pharmacometrics activities to support Dyne Therapeutics’ drug development programs across all stages. This role is responsible for designing and implementing pharmacology and PK/PD modeling &amp; simulation strategies, contributing to translational and early &amp; late clinical development, and collaborating cross-functionally with internal teams and external partners.The ideal candidate will bring deep expertise in clinical pharmacology, hands-on experience with PK/PD modeling (including population PK/PD, PBPK, and QSP), and the ability to translate data into actionable insights for clinical trial design and regulatory submissions. Primary Responsibilities Develop and implement clinical pharmacology and quantitative modeling strategies aligned with regulatory requirements and Dyne’s R&amp;D objectives. Serve as the subject matter expert for Clinical Pharmacology &amp; Biomarkers, providing guidance to cross-functional teams including Medical, Biometrics, Pharmacovigilance, Preclinical Toxicology, ADME/DMPK, and Clinical Development. Conduct hands-on PK/PD modeling and data analyses to support progression from preclinical through late-stage clinical development. Manage external consultants and vendors supporting clinical pharmacology activities. Author high-quality regulatory documents, including INDs, IBs, briefing packages, study reports, and BLAs. Ensure timely and budget-conscious execution of clinical pharmacology deliverables. Collaborate across departments to support program advancement and corporate goals. Education and Experience Requirements PhD, PharmD, or equivalent in Pharmacology, Pharmaceutical Sciences, Engineering, Physics, Applied Mathematics, or Computational Sciences. Minimum of 10 years of experience in clinical pharmacology or biomarker-related functions within the biopharmaceutical industry. Strong knowledge of PK/PD modeling and simulation, regulatory guidance, and drug development processes—particularly for oligonucleotides, biologics, and rare diseases. Experience preparing regulatory documents including pre-IND, IND, IB, CTA, and BLA submissions. Proficiency in modeling tools such as R, Monolix (or equivalent), and data mining platforms. Proven ability to develop innovative dosing strategies for novel drug modalities. Excellent interpersonal and leadership skills with experience influencing in a matrixed environment. Strong communication skills with the ability to foster collaboration and open dialogue across teams. Self-motivated and adaptable, with the ability to manage multiple priorities in a fast-paced setting. &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Clinical Pharmacology

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: Director, CMC Management will be accountable for project and portfolio management activities globally for our products. This role will partner closely with colleagues across Dyne to ensure seamless development of CMC plans for Dyne projects towards commercial readiness. This role is based in Waltham, MA. Primary Responsibilities Include (but limited to): Lead project and portfolio management function to develop CMC timelines, risk register, budgets working with CMC teams (collaborate with CMC, Supply, Quality Control, Quality Assurance, and Clinical Operations) Act as main point of contact for CMC team leaders including working subteams and strategic business teams Responsible for supporting CMC teams with long term strategic plans including LRP, budget planning and timelines across the portfolio Prepare management review presentations with expertise in Smartsheets or MS Project Develop and maintain dashboards, Sharepoint folders and repository for CMC plans for each program Support CTO with LRP, timelines and budget planning across Tech Ops/CMC Act as collaboration point of contact with Dyne PMO and program managers Organize and maintain documentation related to project plans Support Reg CMC with submission timelines e.g. reviews, approvals internally within CMC Champion a strong winning culture, fostering teamwork and commitment to excellent through transparent communication, engagement and collaboration Education and Skills Requirements: Bachelor's Degree in Science or related field, or equivalent with 8-10 years of related work experience, or advanced degree and a minimum of 6 years of work experience Project and portfolio management certificate or expertise; deep knowledge of project management tools e.g. Smart sheet, MS Project, dashboards Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner. Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments. Ability to work, influence, and gain consensus across multiple functions (CMC, Quality and Regulatory Affairs) Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, including IND, BLA, and post-approval changes Strong analytical, problem solving and critical thinking skills; highly organized. Collaborative work style to be part of a team to identify process gaps and develop solutions Excellent interpersonal, verbal, and written communication skills with the ability to work in strong cross-functional relationships and communicate complex issues enterprise-wide, from the executive team to the manufacturing floor. Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, CMC Management

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: &nbsp; We are looking for an experienced and highly skilled Director, Pharmacovigilance Scientist to join our dynamic team. This person will be responsible for monitoring the safety of our pharmaceutical products, ensuring compliance with regulatory requirements, and contributing to the overall risk management strategy. The ideal candidate will have extensive knowledge of pharmacovigilance processes, strong leadership abilities, ability to work collaboratively with multidisciplinary teams, and a commitment to patient safety. This role is based in Waltham, MA without the possibility of being a fully remote role.&nbsp;&nbsp;Primary Responsibilities Include:&nbsp; Signal Detection and Risk Management: Identify and evaluate safety signals through comprehensive data analysis. Author safety signal assessment reports and aggregate safety reports Write and maintain relevant SOPs and procedures in compliance with global safety regulations and guidelines, and provide training within Dyne Drug Safety and Pharmacovigilance and cross-functionally Regulatory Compliance:&nbsp;Prepare and coordinate submission of safety reports (PSURs, DSURs, CIOMS, etc.) to regulatory authorities, ensuring compliance with all local and international regulations Collaboration: Work closely with cross-functional teams, including clinical operations, regulatory affairs, and medical affairs, to address safety issues and develop effective risk&nbsp;minimization strategies Documentation:&nbsp;Maintain accurate and thorough documentation of safety data and related activities in compliance with Good Pharmacovigilance Practices (GVP) Training and&nbsp;Development: Provide training and support to internal teams on pharmacovigilance processes, regulations, and best practices.&nbsp; Education and Skills Requirements:&nbsp; Advanced degree in life sciences (MD, PharmD, PhD, or equivalent) is required.&nbsp; Minimum of 10 years of experience in pharmacovigilance, with at least 2 year in a leadership role In-depth understanding of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH, etc.) Strong analytical and problem-solving skills; proficiency with safety databases and data analysis tools Exceptional written and verbal communication abilities, with a proven&nbsp;track record of effectively presenting complex information to diverse audiences Demonstrated ability to manage multiple projects and deadlines in a fast-paced environment Proven experience in leading teams and fostering a collaborative work environment.&nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Drug Safety & Pharmacovigilance Scientist

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Head of US Commercial Operations will bring their extensive experience to our product launches in neuromuscular disease with an initial focus on launch readiness and commercialization of our lead assets in Duchenne Muscular Dystrophy and myotonic dystrophy Type I (DM1). This individual will be a strategic and hands-on leader responsible for building and managing critical commercial infrastructure, including sales operations, analytics, forecasting, market access operations, and commercial systems. This role oversees sales operations, forecasting and analytics, incentive compensation, US market research, data management, CRM systems, field effectiveness, and commercial training.&nbsp; As part of a high performing team, this role seamlessly collaborates cross functionally to deliver a one Dyne approach, including close collaboration with field roles, Marketing, Medical Affairs, Patient Services, Global Value and Access, Finance, and IT to ensure cohesive and aligned go-to-market strategies and successful execution. As a member of the US leadership team, the ideal candidate has experience in rare disease or specialty pharmaceutical markets and thrives in an entrepreneurial, fast-paced environment.&nbsp;&nbsp; This role is based in Waltham, MA.&nbsp; Primary&nbsp;Responsibilities:&nbsp; Serve as a key member of the US Commercial Leadership Team, developing and executing commercial operations strategy and operating plans.&nbsp; Develops and execute the commercial operations infrastructure to support a successful rare disease product launch in DMD and DM1.&nbsp; Lead commercial planning processes, including sales forecasting, demand planning, incentive compensation design, and territory alignment.&nbsp; Build and oversee a high-functioning sales operations team and associated systems (CRM, data warehousing, reporting dashboards).&nbsp; Establish data governance processes and manage third-party vendors providing data (claims, specialty pharmacy, distribution).&nbsp; Partner cross-functionally with Marketing, Medical Affairs, Patient Services, Global Value and Access, Finance, and IT to ensure alignment of commercial operations with overall corporate goals.&nbsp; Design and manage KPIs and reporting frameworks to track performance and inform commercial decision-making.&nbsp; Lead field force enablement efforts, including CRM configuration, targeting, call planning, and field reporting.&nbsp; Support the development of compliant policies and processes for commercial activities in collaboration with Legal and Compliance teams.&nbsp; Manage operational budgets, contracts, and vendor relationships for commercial functions.&nbsp; Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; The successful candidate should be a dynamic individual with proven abilities as a biopharma commercial leader. S/he will have led successful product launches, driven revenue growth, have a strong reputation for excellent cross-functional collaboration and possess the following:&nbsp; BA/BS degree required; advanced degree (MBA, PhD, PharmD) preferred&nbsp; 10+ years of progressive experience in commercial operations within the biopharmaceutical industry, including at least 5 years in a leadership role.&nbsp; Proven track record of successfully launching and commercializing biotech products, with a strong understanding of the unique challenges and opportunities in the rare disease market&nbsp;&nbsp; Deep understanding of commercial data sources (e.g., specialty pharmacy, HUB services, patient services, claims data).&nbsp; Demonstrated success in building commercial infrastructure in a high-growth or startup environment.&nbsp; Proven analytical and problem-solving skills. Ability to analyze data, understand trends and develop recommendations for action based on analysis&nbsp; Strong project management skills, attention to detail, and ability to lead cross-functional initiatives.&nbsp; Excellent communication and leadership skills with a collaborative approach.&nbsp; Enterprise mindset that makes culture and values come to life in everyday activities&nbsp; Experience in a small, rapidly growing biotech with the ability to operate and maneuver in a start-up environment while keeping a solutions-oriented mentality &nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Head of US Commercial Operations

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director of IT validation leads the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders—especially within GXP environments. This role focuses on the development, execution, and management of IT validation strategies and initiatives for systems across the organization. The Associate Director, IT Validation works cross functionally with IT Security, Quality, Regulatory, and Operations teams to ensure the implementation and ongoing compliance of IT systems with FDA, EMA, SOX, and other global regulations. This role is based in Waltham, MA without the possibility of being a remote role. Primary Responsibilities Include: Lead the development, planning, and execution of IT validation strategies for GxP systems, ensuring compliance with industry standards such as 21 CFR Part 11, GAMP 5, and other relevant regulations Oversee the creation and review of validation documentation, including validation plans, protocols (IQ, OQ, PQ) risk assessments, and traceability matrices Ensure IT systems are maintained in a validated state throughout their life cycle, including upgrades, patches and decommissioning activities. Collaborate with cross functional teams such (e.g., Quality, Regulatory, IT and Operations) to ensure systems meet business needs and regulatory requirements Serve as the subject matter expert on IT Validation—providing guidance and training to protect teams and stakeholders Manage and mentor a team of validation engineers and specialists, ensuring best practices are followed Lead internal and external audits related to IT validation and compliance, preparing responses and driving corrective actions Maintain up-to-date knowledge of global regulatory requirements, validation methodologies, and industry trends, and implement continuous improvement initiatives. Partner with vendors and consultants to ensure external systems and applications are validated in accordance with company policies. Provide oversight of validation efforts for cloud-based systems and applications, ensuring compliance with GXP requirements Education and Skills Requirements: A bachelor's degree in computer science, Information Technology, engineering or related field. Advanced degree preferred Minimum of 10 years of experience in IT validation, including three years in a leadership role with GXP regulated environments In-depth knowledge of FDA regulations. Including 21 CFR Part 11, GAMP 5 and other relevant global regulatory requirements Experience with validation of cloud-based systems and platforms in AWS Proven ability to manage multiple validation projects in a fast-paced environment Strong leadership skills with experience in mentoring and developing high performing teams Excellent verbal and written communication skills with the ability to effectively communicate with stakeholders at all levels of the organization Experience in managing validation activities during internal and external audits Experience managing evidence Collection and dissemination for assessments and audits Excellent analytical and problem-solving skills Ability to thrive in a fast-paced and dynamic environment Outstanding vendor management skills Certification in quality or validation (e.g., ASQ, ISPE) a plus. &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, IT Validation

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director, Managed Markets Liaison (MML) is an experienced field medical expert who plays a strategic role on the field medical team with depth and breadth of business acumen, therapeutic knowledge and serves as an informal leader on the team. The person in this role will be a customer facing, field-based extension of our Medical Affairs team. The MML’s key objective is to create impact through advancing patient outcomes, medication access, and customer experience within an assigned set of national/regional payer accounts. This individual will serve as a key scientific resource, engaging with healthcare decision-makers and other medication access stakeholders to provide scientific, health economic, and clinical support for our portfolio.&nbsp; The Director, Managed Markets Liaison, will report directly to the Executive Director, Medical Affairs Managed Markets Team Lead. Primary Responsibilities Include: Serves as medical lead, engaging in timely and compliant scientific, health economic, disease state exchange with payers and other healthcare decision makers Develops strategic customer account plans that are aligned with both medical and access strategies, including identifying and building relationships with key customers at payer organizations and other healthcare decision makers Gathers high-level customer insights that shape and inform company and access strategy Responds to unsolicited medical information requests in a timely, accurate, and compliant manner Serves as an internal subject matter expert and provides training as needed for Market Access team and other divisions Provides insight, input, and support towards the development of payer facing field tools and resources Builds awareness of the company within the payer and access community Supports internal health economic and outcomes research (HEOR) initiatives Demonstrates thorough knowledge of the company, its investigational products and current research, and payer landscapes impacting the company portfolio Attends key national and regional payer, HEOR, and medical conferences to gather insights, assess the competitive landscape, and strengthen relationships Provides strategic leadership within the team as a peer leader and mentor, motivator, problem solver, and contributes to the overall team strategy Collaborates with internal teams (ie. Market Access, HEOR, MSLs, Patient Advocacy, Commercial, Legal, Compliance) to maintain a customer-centric, compliant approach within assigned territory Manages administrative tasks (e.g., Veeva CRM, expense reports, compliance modules) efficiently, including customer profiling and keeping CRM information up to date Education and Skills Requirements: Advanced scientific degree or equivalent required (e.g., PharmD, PhD, MD) 8+ years of experience in a relevant pharmaceutical industry, managed care, or HEOR role: Experience as a payer focused field medical liaison and/or Experience in account management, formulary management, trade/rebate, Director of Pharmacy, academic detailing, economic modeling/HEOR, etc. Experience with neuromuscular disorders (e.g., DMD, DM1), rare disease, specialty and accelerated approval drugs is highly desired Prior launch experience is a plus Strong understanding of the US payer system Proven ability to work effectively within multidisciplinary teams Clear understanding of the role and responsibilities Skilled in building and maintaining relationships through scientific expertise and follow-through Able to master clinical and health economic data and communicate complex information in a concise and effective way across diverse audiences Effective communication skills (written, verbal, presentation) Expert in planning, prioritizing, and executing tasks efficiently Capable of working independently and managing time in a home office Adaptable in ambiguous and dynamic environments &nbsp; &nbsp; #LI-RemoteThe pay range displayed below is the range of base pay compensation within which the company expects to pay for this role at the time of this posting. Individual compensation depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.Salary Range$215,000&mdash;$246,000 USDThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Managed Markets Liaison

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director, Program Management (PM) is a critical role within the cross-functional development team responsible for facilitating and driving execution across the wide spectrum of activities required for successful development of one or more molecules.&nbsp; The PM partners closely with Program Team Leader (PTL) and functional subject matter experts to ensure that plans are in place with appropriate detail and risk awareness to assure successful achievement of the goals of the development team.&nbsp; The PM ensures integration of these detailed functional plans into a holistic, cohesive and comprehensive program plan that achieves the strategic goals of the development program.&nbsp; Given the inherent uncertainty associated with drug development in rare disorders, the PM maintains an agile mindset in order to effectively incorporate and react to emerging data and course-correct as conditions dictate.&nbsp; Working in close partnership with PTL, the PM effectively frames and facilitates discussions with team members and external experts to elicit clear recommendations and decisions by fully engaging with team members to consider multiple options with a focus on impact on quality, time and cost.&nbsp; Their influencing and engagement skills allow them to work with a highly motivated team and manage stakeholders at all levels of the company. This individual is passionate about developing and commercializing life-transforming therapies for patients with severe and life-threatening diseases and will develop strong knowledge of the Dyne programs (scientific and clinical data, patient population, market environment, etc.). The Program Manager is adept at operating in cross-functional matrix teams, developing effective relationships based on mutual trust and effective communication and thrives in a fast-paced, patient-focused environment.&nbsp; This role is based in Waltham, MA without the possibility of being&nbsp;fully remote. Primary Responsibilities Include: Lead the operations of one or more high performing cross-functional team, with focus on both the “what”, such as priorities, goal achievement, and resources, and the “how” of maintaining a challenging, collaborative, and sustainable team environment Partner with the PTL to identify short, medium, and long-term team priorities and propose path to address Drive execution of the established and aligned Program vision and strategy for bringing a life-changing medicine to patients in need Facilitate creation &amp; maintenance of core program strategy documents including Target Product Profile (TPP), Clinical Development Plan, Regulatory Strategy, and Supply Strategy in collaboration with cross-functional representatives Ensure that non-clinical, clinical, regulatory, and commercial strategies and plans are aligned with the TPP and the overall Program Strategy Inspire development of an efficient plan to achieve development strategy, optimizing for quality, speed and cost Accountable for creation and maintenance of detailed cross-functional plans and effective visual summaries thereof to instill awareness, accountability and achievement Maintain clear and open communication with Program Team, Dyne Senior Leadership, and other stakeholders regarding program status, priorities, risks and needs, and facilitate appropriate strategic decision-making Keep abreast of emerging developments regarding research and development in the fields of muscle diseases and oligonucleotide drug discovery and development Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement &nbsp; Education and Skills Requirements: Bachelor’s degree in science or related field; Advanced degree in a scientific discipline or MBA preferred 10+ years of relevant experience in biotech/pharmaceutical industry in positions of increasing responsibility in drug development Exceptional communication skills (verbal, written, presentation) and ability to communicate with across a broad group of stakeholders and teams Proficient with SharePoint, Microsoft Teams, Smartsheet and other PM management workspace collaboration tools. Expert at cross-functional teamwork and influencing without direct authority Demonstrated experience in working with highly effective teams and guiding teams and organizations in making complex and high-stakes data-driven decisions Proven ability to establish and maintain credible and trust-based relationships Outstanding sense of urgency and ability to help pace the team’s work in highly competitive environment Orientation towards collective achievement and team credit, combined with individual sense of responsibility and accountability for teamwork and product Comfort with ambiguity and ability to provide steadiness and consistency in environment of shifting priorities Ability to lead by influence complex and ambitious projects in a cross-functional team environment and high-pressure circumstances Comfortable in a results-driven, highly accountable environment where you can make a clear impact Team player who listens effectively and invites response and discussion A collaborator who communicates in an open, clear, complete, timely and consistent manner &nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp; Role Summary: The Director, Statistical Programming is accountable for in-house statistical programming activities and oversight of related activities by vendors for assigned clinical development programs. In collaboration with functional line management and cross functional stakeholders, this position contributes to the process optimization and innovation for clinical development. This position serves as an in-house expert for statistical programing and data standards, and assists the team to develop functional strategies and drives the development and continuous improvement of departmental procedures, training and standards. Primary Responsibilities Include: Lead and manage the statistical programming activities for clinical trials and studies, ensuring high-quality deliverables and adherence to timelines Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements Develop, validate, and maintain analysis datasets (CDISC standards), tables, listings, and figures, TLFs) in accordance with regulatory guidelines and internal standards Review statistical analysis plans (SAPs) to provide feedback and strategy to the team to execute the plans Perform complex statistical analyses and simulations using SAS, and R, to support clinical trial design and data interpretation Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD) Build and maintain software agnostic solutions/macros to automate repetitive tasks. Provide novel solutions to the Biometrics and cross-functional teams to better understand the data Manage, mentor and provide guidance to junior programmers, ensuring their growth and development within the team Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis Education and Skills Requirements: MS or BS degree in Statistics, Computer Science, Mathematics, Public Health, or related quantitative fields. MS with a minimum of 12 years or BS with a minimum of 14 years of experience in a pharmaceutical industry or other clinical research setting with clinical trials; direct supervisory experience preferred Highly competent in SAS programming and Macro development; ability to understand the implementation of statistical analyses Preferred knowledge of other programming languages such as R Thorough understanding of ICH Guidelines and relevant regulatory requirements and CDISC standards Familiarity with expectations of regulatory agencies, like FDA, EMA etc. Direct experience with NDA/BLA or other regulatory filing, including ISS or ISE. Experience with departmental resource allocation and labor requirement assessment Excellent written, verbal, and interpersonal communication skills, and strong negotiation, and organizational skills Ability to work effectively and efficiently independently and as part of a functional and cross-functional team Ability to influence without authority Willing and able to demonstrate agility and flexibility as needed in a small biotech Ability to work effectively in a highly dynamic and fast-moving environment Awareness to escalate issues appropriately #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Statistical Programming

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Head of Market Access and Patient Services will bring their extensive market access experience to our first product launches in neuromuscular disease with an initial focus on launch readiness and commercialization of our lead assets in Duchenne Muscular Dystrophy and myotonic dystrophy Type I (DM1). This individual will play a pivotal role in establishing market access and patient services capabilities, partnering with cross-functional product teams to lead the planning and execution of strategies across Market Access, Payer Marketing, Pricing, Reimbursement, Trade &amp; Distribution, Patient Services, Payer Management, Health Policy, and Key Account Strategy. A successful candidate is a self-starter who is highly driven, collaborative, and embodies values such as bold thinking, agility, and an execution-focus.&nbsp; As part of a high performing team, this role seamlessly collaborates cross functionally to deliver a one Dyne approach, including close collaboration with field roles, Marketing, Medical Affairs, Patient Services, Global Value and Access, and Advocacy, to ensure cohesive and aligned go-to-market strategies and successful execution. This is a unique opportunity for an exceptional strategic thinker and commercial leader to play a key role on the US leadership team.&nbsp; This role is based in Waltham, MA &nbsp; &nbsp;Primary Responsibilities:&nbsp; Design a fit-for-purpose market access and patient services organization to enable broad and timely access to Dyne therapies.&nbsp; Build, recruit, and nurture a high-performing team of market access and patient services experts.&nbsp; Develop and implement a comprehensive market access strategy, including pricing, reimbursement, and payer engagement, to support the launch and lifecycle management of Dyne’s product(s)&nbsp; Collaborate with internal and external stakeholders to leverage and implement reimbursement, managed care, payer, and healthcare policies that ensure attainment of business objectives&nbsp; Develop pricing strategies consistent with customer and market indications, as well as US public policy, and the overall portfolio targeting long-term commercial success&nbsp; Design and drive Dyne’s development of market access capabilities within the US, including payer account management/outreach as well as pricing and contracting (as needed) for optimal reimbursement and robust market penetration&nbsp; Work closely with Medical Affairs, Value and Access, and HEOR team members to ensure the creation of a clinical value proposition for Dyne’s products incorporating differentiating and compelling product data to optimize product value&nbsp; Collaborate with cross-functional teams, including trade and distribution, patient services, R&amp;D, finance, marketing, sales, and legal to align market access strategies with business objectives&nbsp; Oversee patient affordability programs to ensure patients have access to Dyne’s products and support services&nbsp; Develop and manage departmental budget ensuring efficient allocation of resources to achieve strategic objectives&nbsp; Ensure compliance with corporate policies and procedures, US healthcare laws and regulations&nbsp; Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; The successful candidate should be a dynamic individual with proven abilities as a biopharma commercial leader. S/he will have led successful product launches, driven revenue growth, have a strong reputation for excellent cross-functional collaboration and possess the following:&nbsp; BA/BS degree required; advanced degree (MBA, PhD, PharmD) preferred&nbsp; Minimum 15 years’ experience in biopharmaceutical marketing and operations, including 5-7 years in market access roles, including leading channel and distribution strategies, government account, and payer account teams.&nbsp; Proven track record of successfully launching and commercializing biotech products, with a strong understanding of the unique challenges and opportunities in the rare disease market&nbsp;&nbsp; Deep understanding of value &amp; access, market structure, competitive landscape, industry trends, and regulatory environment in the US region required&nbsp;&nbsp; Proven analytical and problem-solving skills. Ability to analyze data, understand trends and develop recommendations for action based on analysis&nbsp; Influential personality with the ability to simplify and clarify complex issues to broad and diverse audiences&nbsp; Enterprise mindset that makes culture and values come to life in everyday activities&nbsp; Experience in a small, rapidly growing biotech with the ability to operate and maneuver in a start-up environment while keeping a solutions-oriented mentality&nbsp;&nbsp; Demonstrates an authentic willingness and capability to roll up sleeves rather than relying on others for delivery&nbsp; Ability to travel to meet business objectives.&nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Head of Market Access & Patient Services

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Head of US Marketing is an experienced and hands-on leader who defines US brand strategy across HCP and Patient communities in neuromuscular disease. This will require strong engagement and leadership of US teams to ensure effective and aligned cross-functional implementation of brand strategy, as well as strategic planning capabilities to ensure flawless execution and a successful launch of our products for DMD and DM1.&nbsp;&nbsp; As part of a high performing team, this role seamlessly collaborates cross functionally to deliver a one Dyne approach, including close collaboration with Field roles, Medical Affairs, Patient Services, Advocacy, and Market Access to ensure cohesive and aligned go-to-market strategies and successful execution. This is a unique opportunity for an exceptional marketer, strategic thinker, and commercial leader to play a key role on the US leadership team.&nbsp; This role is based in Waltham, MA.&nbsp; &nbsp;Primary Responsibilities:&nbsp; Marketing &nbsp; Developing differentiated marketing strategies including digital and omnichannel engagement tactics for the US; developing and implementing initial brand plans&nbsp; Leading the development and execution of integrated cross functional brand plans in strong partnership with above market team&nbsp; Coordinating with the US Marketing Team on tactics with global reach, including Congresses, KOL engagement, Education, Awareness, and digital initiatives&nbsp; Working in partnership with Medical Affairs on the development of initiatives to build HCP-level brand advocacy &amp; brand adoption&nbsp; Ensuring integration of Patient Advocacy across all relevant US deliverables, programs, and activities&nbsp; Drive innovation in commercial strategy and tactics to build brand awareness, excitement, and intent to prescribe while ensuring superior execution of market development efforts&nbsp; Working closely with Insights &amp; Analytics to support any message testing, market research, and insight generation – instilling a metrics driven mindset and strong focus on executional discipline including constant monitoring of impact on prescription behavior and other KPIs&nbsp;&nbsp; Working closely with legal to champion the compliance interface for commercial, ensuring appropriate governance, tracking and signoffs are in place for all commercial activities and materials (with support from cross-functional partners)&nbsp; Support definition, and achievement, targets, KPIs, and metrics including for HCP adoption, advocacy, and advocacy mobilization&nbsp; &nbsp;Launch Planning &nbsp; Leading coordination and execution of launch planning for DMD and DM1&nbsp; Developing launch strategy&nbsp; Building integrated cross-functional launch plans&nbsp; Developing core messages&nbsp; Identifying and coordinating critical educational and promotional activities supporting launch activities and market development&nbsp; Identifying and coordinating critical Patient Advocacy plans and media engagement&nbsp;&nbsp; Developing cross-functional launch plans for US markets, prioritizing activities and identifying key opportunities and challenges&nbsp;&nbsp; Effectively transferring key learnings between markets to accelerate the success of later launches&nbsp; Develop and implement KPI’s to ensure high quality and speed in execution to outperform in the marketplace and drive market share towards market leadership&nbsp;&nbsp; &nbsp;Leadership: &nbsp; Develop and lead the US Marketing team, fostering a culture aligned with company values&nbsp; Executive presence. Strong leadership qualities with the ability to attract talent, drive high performance and create a collaborative culture, fostering open communication, constructive conflict management and organizational flexibility.&nbsp; Establish Dyne as a trusted, enduring partner amongst the neuromuscular community and play a pivotal role in building and driving Dyne’s reputation&nbsp; Synthesize key customer insights and stakeholder dynamics and bring to leadership to inform evolution and optimization of strategy, tactics, messaging, and program execution&nbsp; Stay abreast of industry trends, market dynamics, and the competitive landscape to identify opportunities and drive competitive differentiation of Dyne’s platform and pipeline of novel treatments&nbsp; Secure necessary resources and collaborate with matrix teams to lead business planning, ensuring deep customer and competitive insights&nbsp;&nbsp; &nbsp; Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; The successful candidate should be a dynamic individual with proven abilities as a biopharma commercial leader. S/he will have led successful product launches, driven revenue growth, have a strong reputation for excellent cross-functional collaboration and possess the following:&nbsp; BA/BS degree required; advanced degree (MBA, PhD, PharmD) preferred&nbsp; Minimum 15 years’ experience in a biopharmaceutical marketing and operational experience&nbsp; Proven track record of successfully launching and commercializing biotech products, with a strong understanding of the unique challenges and opportunities in the rare disease market&nbsp;&nbsp; Deep understanding of value &amp; access, market structure, competitive landscape, industry trends, and regulatory environment in the US region required&nbsp;&nbsp; Proven analytical and problem-solving skills. Ability to analyze data, understand trends and develop recommendations for action based on analysis&nbsp; Influential personality with the ability to simplify and clarify complex issues to broad and diverse audiences&nbsp; Enterprise mindset that makes culture and values come to life in everyday activities&nbsp; Experience in a small, rapidly growing biotech with the ability to operate and maneuver in a start-up environment while keeping a solutions-oriented mentality&nbsp;&nbsp; Ability to collaborate with ex. U.S. colleagues in aligning on marketing objectives and key strategies&nbsp; Demonstrates an authentic willingness and capability to roll up sleeves rather than relying on others for delivery&nbsp; Ability to travel to meet business objectives.&nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Head of US Marketing

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Senior Director, Drug Product Manufacturing will be accountable for all activities related to successful development and manufacturing operations and drug product related activities globally for our products. This role will partner closely with colleagues across Dyne to ensure seamless supply of all drug product for clinical trials and will lead efforts for drug product commercial readiness and launch.&nbsp; This role is based in Waltham, MA without the possibility of being fully remote.&nbsp; Primary Responsibilities Include:&nbsp; Act as the subject matter expert in drug product development including formulation, container closure and sterile fill finish manufacturing&nbsp; Act as main point of contact for CDMO(s) including leading CDMO working teams and strategic business review chairperson&nbsp; Responsible for tech transfer, scale-up and cGMP manufacturing of drug product including PPQs&nbsp; Responsible for ensuring uninterrupted drug product supply for clinical studies, commercial readiness and launch&nbsp; Key contributor to drug product sections of BLAs/NDAs/INDs/IMPDs&nbsp; Collaborate with CMC, Quality Control, Quality Assurance, and Clinical Operations to ensure continuity of drug supply&nbsp; Responsible for driving execution of the production plan at CDMO (PO through delivery)&nbsp; Working with CMC, Legal, and Strategic Sourcing take the lead in identification and resolution of business/contract issues and supply agreements&nbsp; Partners with CMC, Quality and Regulatory to champion a culture of quality with our CDMO's and to ensure that all activities and documentation comply with regulatory requirements&nbsp; Partner with Strategic Sourcing to develop and implement long term external manufacturing strategies that provide a reliable, robust, and cost-effective manufacturing network&nbsp; Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration&nbsp; &nbsp;Education and Skills Requirements:&nbsp; Bachelor’s degree in science, chemical engineering or related field, or equivalent with 12+ years of related work experience, or advanced degree and a minimum of 8 years of work experience.&nbsp; Proven experience in clinical and commercial drug product formulation development including liquid fill finish, lyophilization and other injectables.&nbsp; Expertise in sterile fill finish manufacturing as well as understanding of analytical techniques that support manufacturing activities.&nbsp; Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing.&nbsp; Strong experience and knowledge of cGMP manufacturing requirements and experience in PPQ planning and execution to support BLAs/NDAs.&nbsp; Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.&nbsp; Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments.&nbsp; Ability to work, influence, and gain consensus across multiple functions (CMC, Quality and Regulatory Affairs).&nbsp; Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, including IND, BLA, and post-approval changes.&nbsp; Strong analytical, problem solving and critical thinking skills.&nbsp; Expertise in use of MS Excel, as well as demonstrated proficiencies in Smartsheet, Visio, ERP systems and Power BI (or similar application).&nbsp; Collaborative work style to be part of a team to identify process gaps and develop solutions.&nbsp; Excellent interpersonal, verbal, and written communication skills with the ability to work in strong cross-functional relationships and communicate complex issues enterprise- wide, from the executive team to the manufacturing floor.&nbsp; Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors.&nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Drug Product Manufacturing

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety profiles of Dyne products and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing). This role will provide short- and long-term strategic leadership of safety surveillance for Dyne’s clinical development programs, including resource planning and long-range capability development to ensure high quality characterization of the safety profiles of Dyne molecules and compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management. This role will oversee cross-functional Signal Detection and Safety Surveillance Teams, guiding the analysis, interpretation and presentation of safety data to stakeholders as needed. This role also contributes to the safety content of regulatory and study documents and collaborates actively with colleagues in numerous cross-functional departments. This role is based in Waltham, MA without the possibility of being&nbsp;fully remote. Primary Responsibilities Include: Conduct and/or oversee activities related to signal detection and evaluation, risk classification, management and communication, including leadership of Signal Detection and Safety Surveillance Teams, as part of continuous benefit-risk evaluation throughout the lifecycle of Dyne products from First-in-Human (FIH) to post-marketing Review safety data of non-clinical studies and from other sources to inform clinical development safety monitoring strategies and plans, including identification of safety-related biomarkers Contribute to the Safety Governance process through the preparation and presentation of safety data and provision of recommendations for review and approval by the Safety Management Committee Perform medical review of ICSRs in Dyne’s Global Safety Database including but not limited to case narrative, MedDRA coding, causality, company comment and queries Develop Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), and responses to health authorities’ requests for safety information Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), IB Reference Safety Information (RSI), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, and other relevant documents Provide strategic guidance and draft responses to safety-related requests and questions from Health Authorities Assist in planning the Pharmacovigilance Department budget, develop short-term and long-term goals for the department in accordance with overall Company and Development strategies Review safety content of scientific publications such as posters, abstracts, and manuscripts. Participate in cross-functional projects and teams Engage with external consultants and advisors as needed to inform interpretation of emerging safety signals. Serve as an exemplary leader, mentor, and trainer Education and Skills Requirements: MD is required Minimum 12 years’ experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety &amp; pharmacovigilance, including cross-functional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development Experience with safety data visualization tools and other technologies supporting safety surveillance Excellent verbal communication and presentation skills with ability to write clearly and concisely, and to formulate science-based arguments in addressing questions regarding safety from Health Authorities and other parties, and in characterization of the safety profiles of Dyne molecules in development Experience in authoring DSUR and other aggregate safety reports Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations, and ability to integrate relevant aspects of these documents into safety surveillance and reporting Line management / direct reports experience is strongly preferred In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies Strong knowledge of statistical methods used in PV Proven abilities to lead significant process improvements in PS Exceptional interpersonal skills and understanding of team dynamics. Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively inform the conduct of safety surveillance Ability to thrive in a fast-paced environment while providing appropriate attention to detail. Ability to effectively present recommendations / opinions in group environment both internally and externally &nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Drug Safety and Pharmacovigilance

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Vice President, Global Patient Advocacy is an experienced and hands-on leader who defines the strategy for and manages all patient engagement, communications and programs. This individual is a member of the Corporate and Patient Affairs (C&amp;PA) team where they contribute to overarching Dyne objectives and plans by developing and implementing global and regional advocacy strategies and initiatives. This role collaborates cross-functionally to cultivate and advance strategic partnerships with key stakeholders, including regional, national and global patient advocacy organizations (PAOs), policy stakeholders, healthcare professionals and medical organizations to drive shared objectives with patient communities and to support Dyne corporate and program goals. The VP, Global Patient Advocacy is the primary Dyne contact and relationship manager for PAOs and patients/families, and leads on coordination when other functions interface with these stakeholders. In addition to the C&amp;PA team, this role is expected to contribute to enterprise-wide thinking and projects with key cross-functional partners including Medical Affairs, Clinical Development, Clinical Operations, Regulatory Affairs, Legal, Compliance, Commercial, and Research. This role is based in Waltham, MA without the possibility of being a remote role. Primary Responsibilities Include: Define the strategic plan for and holistic company philosophy on patient advocacy Strategic plan should identify and drive corporate and program goals which are aligned with the shared goals of PAOs, individuals living with neuromuscular diseases and their families and caregivers Tactics within the plan may include but are not limited to webinars, educational programs, disease awareness initiatives, advisory boards, patient speaker engagement, clinical trial awareness, and policy advocacy, as well budget and metrics Ensure systematic inclusion of patient and caregiver perspectives at corporate and program levels, including into policy and access initiatives and clinical trial designs Lead cross-functional teams that develop programs, communications and collateral to educate patient/family and PAO audiences on Dyne programs Support PAOs with regulatory bodies and payors to reinforce innovation and access Identify, establish and ensure that the infrastructure, resources and processes are in place to execute the overall patient advocacy and engagement strategy Databases and related tracking tools for all Dyne PAO engagements Management, tracking and assessment of all engagements, key actions and insights obtained from interactions between Dyne and PAOs and individuals Lead Dyne’s cross-functional grants and sponsorships committee, plan and process with support from the C&amp;PA operations manager Manage intake, review and approval of PAO-related conference sponsorship and program support grant requests Own compliant individual patient engagement Develop and secure approval for patient facing responses to inquiries received from patient communities regarding Dyne’s clinical trials, drug development programs and other related topics Track all patient channels (email boxes, Facebook and other social media chat functions, etc.) and provide prompt and thoughtful responses Develop and maintain policies and procedures for patient engagement Drive presence at PAO events and meetings and share takeaways Lead the organization and execution of internal employee events involving and/or supporting patients and PAOs (i.e., patient speakers, Rare Disease Day, etc.) Contribute to insight generation and implications with cross-functional partners Serve as Dyne’s subject matter expert on patient-centric industry and advocacy practices and trends, and provide perspectives and education to senior leadership Define and manage budget to deliver on pre-specified metrics Understand and abide by all relevant compliance regulations Education and Skills Requirements: Minimum of a bachelor’s degree in life science-related discipline preferred Minimum of 10 years of experience in patient advocacy, including in a clinical-stage biotechnology company Expert understanding of the patient community, preferably with experience in neuromuscular disorders and/or rare disease Deep understanding of patient advocacy codes of conduct, regulations and guidelines across geographies Experience working on global cross-functional teams across development phases from discovery through commercialization Compelling leadership style with a willingness to be hands-on and – initially asan advocacy team of one Experience building and managing teams Ability to work independently with strong organizational, prioritization and analytical skills Strong cross-functional partner Strong verbal, written and interpersonal communication skills Vendor, project and budget management experience Ability to influence without authority at all levels of the organization Ability to travel in the U.S. and outside of the U.S. on a regular basis, approximately 25-30% of time, often over weekends &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

VP, Global Patient Advocacy

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The VP, Pharmaceutical Quality is the functional head of product quality for the company, overseeing quality assurance and quality control, and managing the total cGMP compliance function. This individual will be responsible for ensuring compliance with established company cGMP quality policies, practices, standard operating procedures (SOPs) and federal regulations.&nbsp; Managing and overseeing quality assurance and quality control at external vendors, auditing manufacturing, testing and supply sites, and providing support for regulatory filings and inspections. &nbsp; This role is based in Waltham, MA without the possibility of being&nbsp;fully remote. Primary Responsibilities Include: &nbsp; Design, implement and maintain cGMP QA and QC programs, and the compliance infrastructure. This includes the cGMP-related SOP system, training programs, and performing internal and external audits&nbsp; Work with the company’s external suppliers including clinical manufacturing organizations (CMOs) and contract labs to ensure consistent cGMP quality and compliance&nbsp; Direct development and implementation of cGMP quality systems to ensure product reliability, quality, efficacy, compliance with applicable SOPs, cGMP regulations; phase-appropriate quality systems and approach&nbsp; Lead resolution of product complaint, OOS and OOT investigations in phase-appropriate manner; lead and manage Material Review Board (MRB)&nbsp; Lead setting up and managing stability program for pre-commercial and commercial products; data analyses and stability sections of regulatory filings&nbsp; Oversee cGMP compliant auditing program to fulfill regulatory requirements&nbsp; Develop, manage and monitor adherence to the overall Quality and Compliance at Dyne&nbsp; Develop, analyze and report business metrics and highlights; manage department budget&nbsp; Manage inspections by the FDA, other regulatory agencies and commercial partners at CMOs&nbsp; Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements&nbsp; Manage and build a team suitable for the growing needs of the organization&nbsp; Education and Skills Requirements: Bachelor’s degree in science or a related field; advanced degree strongly preferred&nbsp; 15+ years’ experience in the pharmaceutical or biotechnology industry in cGMP quality and compliance role&nbsp; 5+ years’ experience as a functional head of a quality department&nbsp; Strong cGMP knowledge in the pharmaceutical industry and implementing a phase-appropriate cGMP quality system&nbsp; Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)&nbsp; Proven record of developing and maintaining successful working relationships with regulatory agencies &nbsp; Demonstrated understanding of the principles and applications associated with external&nbsp; manufacturing operations from development to clinical manufacturing.&nbsp; Strong experience and knowledge of cGMP manufacturing and stability to support BLAs/NDAs.&nbsp; Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.&nbsp; Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments.&nbsp; Ability to work, influence, and gain consensus across multiple functions (CMC, R&amp;D, and Regulatory Affairs).&nbsp; Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, including IND, BLA, and post-approval changes&nbsp; Strong analytical, problem solving and critical thinking skills&nbsp; Excellent interpersonal, verbal, and written communication skills with the ability to work&nbsp; in strong cross-functional relationships and communicate complex issues enterprise- wide, from the executive team to the manufacturing floor.&nbsp; Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors.&nbsp; &nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

VP, Pharmaceutical Quality

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Principal Scientist, ADME-PK in Preclinical Development (PCD) department utilizes their knowledge in drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles to advance Dyne’s efforts surrounding delivery of therapeutic payloads to muscle and CNS tissues with the FORCE platform.&nbsp; This role is based in Waltham, MA. Primary Responsibilities Include: Design and execute internal/external preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of Dyne’s drug candidates&nbsp; Represent PCD as the ADME-PK subject matter expert on discovery and program teams&nbsp; Partner with and support Research, Toxicology, Translational Biomarkers, Clinical, Regulatory, Project Management and other Dyne departments&nbsp; Collaborate with Clinical Pharmacology/Pharmacometrics to develop quantitative tools to translate PK/PD relationship from preclinical to clinical&nbsp; Author high quality Regulatory documents including INDs, CTAs, and NDA/BLA filings.&nbsp; Prepare strategic and science-based ADME strategies that meet regulatory requirements and program goals&nbsp; Facilitate strategic scientific communication via meetings, abstracts and manuscripts&nbsp; Education and Skill Requirements: PhD in Pharmacokinetics, Pharmacology, Pharmaceutics, Biomedical Sciences or other relevant field with &gt;6 years (MS with &gt;8 years, BS with &gt;12 years) of experience in the biopharmaceutical industry, with evidence of drug development experience&nbsp; Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamics and bioanalytical principles&nbsp; Familiarity with regulatory submission including FIH dosing strategy is highly desirable&nbsp; Proficient in using WinNonlin or other pharmacokinetic software&nbsp; Excellent communication (verbal and written) and presentation skills, as well as interpersonal skills and the ability to represent PCD in a team environment&nbsp; Experience with PK characterization of protein therapeutics or antibody-drug conjugates (ADCs) is desired&nbsp;&nbsp; #LI-OnsiteMA Pay Range$159,000&mdash;$195,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Principal Scientist, ADME-PK

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Senior Director, Drug Substance Manufacturing is responsible for leading GMP drug substance manufacturing, process performance qualification (PPQ), ensuring commercial supply, and overseeing all CMC activities related to Fab-oligonucleotide conjugates (drug substance). &nbsp;This role includes strategic vendor management for commercial drug substance production and coordination of external development and manufacturing activities with contract development and manufacturing organizations (CDMOs), contract testing laboratories (CTLs), and other key suppliers.&nbsp; This role works closely with key stakeholders including Development, R&amp;D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.&nbsp; This role is based in Waltham, MA.&nbsp; Primary Responsibilities Include:&nbsp; Responsible for bioconjugation activities including validation, characterization, scale-up, clinical and commercial manufacturing.&nbsp;&nbsp; Establish and manage contracts, supply agreements and CDMOs&nbsp; Oversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis&nbsp; Work closely with CMC Technical Development to support bioconjugation improvement activities and enhance the tech transfer process&nbsp; Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials&nbsp; Prepare and review CMC documentation for biologic INDs and BLAs and support FDA and EMEA interactions&nbsp; Support the development of regulatory CMC documentation and partner due diligence&nbsp; Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed and closed within target timeframes&nbsp; Provide patents and creative ideas to provide protection or creation of new or better products or processes&nbsp; &nbsp; Education and Skills Requirements:&nbsp; Bachelor’s degree in biology, biochemistry, chemistry, or a related scientific field required; advanced degree preferred.&nbsp; Minimum 12 years of experience in biopharmaceutical manufacturing, including CMC management and oversight of complex development programs.&nbsp; Proven expertise in bioconjugates, as well as strong knowledge of biologics and small molecule manufacturing, materials management, quality control/assurance, and CMC regulatory requirements.&nbsp; Demonstrated experience in leading contract manufacturing and managing external partners such as CDMOs and CTLs.&nbsp; Comprehensive experience with CMC regulatory submissions across all phases of development, ideally including post-approval activities, global regulatory interactions, and negotiations with health authorities on CMC issues related to biologic APIs.&nbsp; Strong understanding of processes and systems supporting biopharmaceutical development, with the ability to challenge current practices and drive continuous improvement.&nbsp; Exceptional leadership and interpersonal skills, including the ability to influence without authority, motivate teams, and collaborate effectively across functions and organizational levels.&nbsp; Highly organized with demonstrated ability to prioritize workload, manage multiple programs in a fast-paced, deadline-driven environment, and consistently deliver on objectives.&nbsp; Skilled in strategic thinking and problem-solving, with the ability to evaluate options, identify pros and cons, and implement creative solutions.&nbsp; Excellent communication and negotiation skills, capable of building consensus and achieving win-win outcomes across diverse stakeholders.&nbsp; Self-directed and adaptable, able to work independently with limited guidance in a complex and evolving environment.&nbsp; &nbsp; &nbsp; #LI-OnsiteMA Pay Range$217,280&mdash;$266,750 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Drug Substance Manufacturing

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. &nbsp;This position supports Dyne’s clinical registration, commercial development, and manufacturing efforts, as applicable. &nbsp;This position partners with the manufacturing team, clinical operations, quality, other regulatory team members, and program teams. &nbsp;&nbsp; This role is based in Waltham, MA&nbsp; Primary Responsibilities Include: Lead CMC&nbsp;Regulatory execution for specific programs at all stages of development&nbsp;&nbsp; Provide strategic Regulatory input to the Manufacturing and Quality organizations&nbsp;pertaining to&nbsp;global product development requirements&nbsp; Serve as a CMC strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with input&nbsp;and guidance&nbsp;from the&nbsp;team and leadership&nbsp; Lead the development of CMC documentation&nbsp;pertaining to&nbsp;global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests with authoring support from Manufacturing and Quality team members, including&nbsp;amendments to clinical and commercial manufacturing changes&nbsp; Responsible for the coordination and management of global submissions, maintenance of product compliance, and management of change control&nbsp;related activities&nbsp; Leverage both technical and regulatory knowledge to&nbsp;proactively&nbsp;mitigate risks&nbsp; Serves as the Regulatory Affairs CMC representative&nbsp;in functional&nbsp;and team&nbsp;meetings&nbsp; Act as point of contact to cross-functional teams on global Regulatory CMC project/program issues&nbsp; Execute regulatory policies and operational processes&nbsp;to&nbsp;deliver high quality regulatory submissions&nbsp; Education and Skills Requirements: Minimum of a bachelor’s degree in life science or related discipline is&nbsp;required&nbsp; Minimum of 7 years of experience in the biotech/pharmaceutical industry&nbsp;with&nbsp;a minimum of 5 years in regulatory affairs in a clinical-stage&nbsp;and/or commercial&nbsp;biotechnology company&nbsp; Experience in Rare Disease preferred&nbsp;&nbsp; Experience leading and developing CMC sections of&nbsp;Biologics&nbsp;marketing applications preferred&nbsp; Solid&nbsp;understanding&nbsp;of FDA regulatory guidance, ICH guidelines&nbsp; Strong experience with CTD format and content&nbsp;of&nbsp;regulatory filings&nbsp;&nbsp;&nbsp; Thorough understanding of drug development process&nbsp;and&nbsp;the pharmaceutical industry&nbsp;including&nbsp;global&nbsp;regulatory&nbsp;CMC&nbsp;requirements, guidance, accelerated regulatory review paths, and policy trends&nbsp; Knowledge of EU and international regulations related to clinical&nbsp;and&nbsp;nonclinical, development a plus&nbsp; Ability to work independently to manage multiple projects in a fast-paced environment&nbsp; Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones&nbsp; Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior management&nbsp; Outstanding communication skills (verbal and written), regulatory writing&nbsp;skills&nbsp;and willingness to share knowledge and lessons learned with strong attention to detail&nbsp; Recognized as a leader, team player, and&nbsp;possess&nbsp;a cross-functional collaborative skill set&nbsp; Ability to influence without authority&nbsp;&nbsp; Positive team member who embodies the Dyne Core Values&nbsp; Excitement about Dyne’s vision and mission&nbsp;&nbsp; &nbsp; &nbsp; #LI-OnsiteMA Pay Range$159,000&mdash;$195,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, Regulatory CMC

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director of Training leads the vision, strategy, and execution of Dyne’s training programs, ensuring all field-facing teams are equipped with the knowledge, skills, and capabilities needed to excel. This role oversees the development, integration, and continuous enhancement of training frameworks, curricula, digital learning assets, and capability-building initiatives that support both initial onboarding and ongoing professional development across all functions required for Account Management. The Director provides strategic oversight of vendors and training partners to ensure consistency, quality, and alignment across the commercial field. Working cross-functionally with Commercial Leadership, Medical Leadership, Compliance, Marketing, HR, and Field Leadership, this role translates strategic business priorities into high-impact learning solutions that elevate field performance and drive commercial excellence. This leader guides the development of modern learning systems and processes, identifying capability gaps through data, field insights, and performance metrics. The Director plays a key role in supporting product launches, enhancing field readiness, and strengthening leadership capabilities throughout the organization. Through innovative training strategies and disciplined execution, this role ensures Dyne’s field teams are prepared to deliver exceptional customer experiences and achieve business goals. This role is located at our office in Waltham, MA. Primary Responsibilities: Coordination of the new hire training and ongoing skills/knowledge training across all cross functional field-facing facing teams. Ensure that the training curriculum and on-boarding processes meet the current and emerging needs of the field-facing employees. Oversee the development, updating, and use of all training modules that are appropriate for field employees. Create training materials that enhance the learning process; including study guides, home study materials, assessments, frequently asked questions, competitive overviews, etc. Lead field employee training across all settings which include 1:1 meetings, conference calls, live classroom, etc. Gather and analyze data from direct field observations, focus groups, and other methods to identify potential training gaps and suggest areas for improvement that will enhance performance and achieve Dyne’s goals. Manage the training of field employees on cross functional business rules (ie. Veeva CRM, Concur, Patient Services data/CRM, etc.). Work closely with cross functional Leadership to ensure that the development of training initiatives is designed to strengthen the&nbsp;pull through of Dyne’s Field Leader capabilities and competencies. Cross Functional Collaboration Support leadership in leading content development workstreams across field meetings from an objective, content, and agenda standpoint. &nbsp; Work with the cross-functional teams to gather feedback on training needs and development of necessary meeting workshops to meet those needs. Work with account leadership to facilitate management-level “train-the-trainer” sessions. Assist field teams and account leadership with field coaching, recruiting, and interviewing as needed. Systems and Employee On-going Personal Development Create and manage the Learning Management System (LMS), and all vendors related to field training and development resources. Work with corporate compliance and/or our compliance agency partner to ensure field employees are trained and up to date on policies and procedures that affect their respective functional areas. Other duties as assigned Education, Experience, &amp; Skills: Bachelor’s degree (science or business preferred) or equivalent combination of relevant education and applicable job experience may be considered. MBA preferred. A minimum of 12 years’ progressively responsible experience in pharmaceutical or medical sales and training, with a minimum of 6 years in a training or field leadership role. A focus on neuroscience and Rare Disease preferred. Requires prior pharmaceutical field experience, first-line pharmaceutical/biotech field management experience, and vendor and contract management. Experience with product launches and Account Management experience is highly desired. Demonstrated leadership and teaching/facilitation ability. Proven ability in creating effective training materials. Proven application of adult learning principles. The ability to successfully navigate challenging situations and conversations with diplomacy, respect and flexibility when required. Experience in launching a product in a rare disease Excellent interpersonal and communication skills. Ability to complete verbal and written evaluations of others. Organization, initiative, and self-motivation. Project and vendor management experience. Professionalism, integrity, and the ability to comply with strict policy, work in a highly regulated environment and maintain confidential information and data. Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization. Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals. Ability to travel up to 30% overnight. #LI-OnsiteMA Pay Range$188,000&mdash;$230,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director of Training

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Director, Patient Marketing leads the development and execution of patient-focused strategies and initiatives that empower individuals and families affected by Duchenne Muscular Dystrophy. In an active launch environment, this role is pivotal in driving rapid, impactful patient engagement programs that support successful market entry and adoption. It blends strategic vision with hands-on execution, ensuring Dyne delivers meaningful engagement, education, and advocacy programs aligned with our mission and brand objectives. You operate with agility to meet critical launch milestones, leveraging innovative technologies and omni-channel tactics to maximize patient reach. Collaboration across Marketing, Patient Advocacy, Medical Affairs, Market Access, and Field teams is essential to create a cohesive patient experience from awareness through treatment, while continuously optimizing based on real-time insights and launch KPIs. This role is based in Waltham, MA Primary Responsibilities: &nbsp; Patient-Centric Strategy &amp; Execution Develop and implement comprehensive patient engagement strategies across Dyne’s therapeutic areas, grounded in deep understanding of the patient journey and unmet needs. Lead the development and rapid execution of launch-focused DSE and branded patient campaigns, ensuring alignment with brand objectives and critical timelines. Design and execute omni-channel campaigns (digital, social, email, events) to educate and empower patients and caregivers. Design and execute Patient Support Services branding and field resource pull through. Partner with creative agencies to develop patient-facing materials, websites, and educational resources. Community Engagement &amp; Advocacy Build and manage patient ambassador programs, including recruitment, training, and event participation. Collaborate with advocacy organizations and patient advisory boards to ensure authentic representation and feedback. Support national and regional advocacy events, conferences, and community programs, including occasional evenings/weekends. Education &amp; Compliance Ensure all patient marketing initiatives adhere to FDA regulations, privacy standards, and Dyne’s compliance policies. Insights &amp; Innovation Leverage market research and patient insights to inform strategy and optimize engagement tactics. Identify emerging trends and technologies to enhance patient experience and access. Cross-Functional Collaboration Work closely with US Marketing Brand Lead and Patient Advocacy teams to align patient initiatives with overall brand strategy. Coordinate with Medical Affairs and Market Access to ensure integrated support for patients and caregivers. Represent marketing function as the PRC reviewer for all promotional material. Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; BA/BS degree required; advanced degree (MBA, MPH) preferred 10+ years in biopharma marketing, with at least 5 years focused on patient engagement or advocacy Proven track record in rare disease or specialty markets; neuromuscular experience is a plus Strong understanding of patient literacy and ability to translate complex science into accessible language Excellent communication and cultural competency skills Ability to lead cross-functional teams and manage agency partners Familiarity with FDA regulations and compliance requirements Experience in a small, rapidly growing biotech with the ability to operate and maneuver in a start-up environment while keeping a solutions-oriented mentality Demonstrated strength in digital marketing, media strategy, and leveraging innovative technologies (including AI-driven solutions) to enhance patient engagement and education. Motivated by an unwavering commitment to patients Ability to travel up to 25% &nbsp; #LI-BJMA Pay Range$188,000&mdash;$230,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Patient Marketing

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: Dyne Therapeutics seeks a strategic and execution-oriented Executive Director, Corporate Development to lead external growth initiatives. Reporting to the Chief Business Officer (CBO), this role focuses on identifying and executing partnership and alliance opportunities aligned with Dyne’s neuromuscular focus and expansion of the FORCE platform into new therapeutic areas. The Executive Director, Corporate Development works closely with the CBO, Chief Innovation Officer, CSO, CFO, IR team, and other executives to drive strategic assessments and investor messaging.&nbsp; The role can be remote with travel to Waltham, MA.&nbsp; Key Responsibilities&nbsp; Business Development Execution:&nbsp; Support and drive business development efforts including preparing pitch decks, engaging with counterparties, supporting due diligence, and negotiations.&nbsp; Lead term-sheet development and negotiation in collaboration with CBO, Legal and Finance.&nbsp; Coordinate cross-functional diligence efforts across scientific, clinical, CMC, commercial, and IP domains.&nbsp; Manage external advisors, data rooms, and timelines to ensure efficient transaction execution.&nbsp; Strategic Planning:&nbsp; Define strategy and support indication assessments for Dyne’s initiatives to expand the reach of its FORCE platform beyond neuromuscular disease.&nbsp; Build market maps and identify strategic whitespace opportunities aligned with Dyne’s platform capabilities.&nbsp; Conduct competitive intelligence and landscape analysis to inform prioritization.&nbsp; Develop scenario models and strategic frameworks to evaluate new therapeutic areas and partnership opportunities.&nbsp; Investor Messaging:&nbsp; Support messaging for key investor meetings by conducting deep analysis of the competitive landscape and Dyne’s position within it.&nbsp; Lead end-to-end execution of partnership and alliance transactions, including diligence, valuation, and negotiation.&nbsp; Maintain a prioritized pipeline of external opportunities aligned with Dyne’s strategy.&nbsp; Collaborate cross-functionally to integrate scientific, clinical, and commercial insights into deal assessments.&nbsp; Develop board-ready investment cases and strategic recommendations.&nbsp; Represent Dyne externally with potential partners, investors, and at industry events.&nbsp; Qualifications&nbsp; 12+ years of experience in biotech/pharma corporate development, business development, strategy, or related fields.&nbsp; BA/BS required; MBA or advanced degree in life sciences (PhD/MD/PharmD) preferred.&nbsp; Proven track record of executing partnerships, alliances, and strategic transactions.&nbsp; Strong scientific literacy and ability to collaborate with R&amp;D and innovation teams.&nbsp; Excellent communication skills and experience preparing investor-facing materials.&nbsp; Timeliness and effectiveness of partnership execution.&nbsp; Impact of strategic assessments on corporate direction.&nbsp; Quality and clarity of investor messaging and materials.&nbsp; &nbsp; &nbsp;MA Pay Range$241,000&mdash;$295,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Executive Director, Corporate Development

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Overview: The Head of Portfolio Strategy and Operations (PS&amp;O) drives successful delivery of key corporate objectives by ensuring the robust development of portfolio and program strategy and effective translation of strategy into integrated planning and timely operational execution across Dyne. The Head of PS&amp;O reports into the Chief Executive Officer (CEO) and is a member of the Dyne Executive Committee (EC). The Head of PS&amp;O oversees Program Leadership, Program Management and Clinical Operations at Dyne by managing, coaching and guiding the Head of Clin Ops, Head of PM and the Program Team Leaders to enable exceptional performance of cross-functional Program Teams and clinical studies across the Dyne portfolio: Leads high-performing team of Program Team Leaders, driving the articulation of program strategy, vision, goals and priorities, bringing both a 'future- orientation' toward the ultimate goal of broad, global commercial access for patients in need, and a "pragmatic-orientation" to chart the path, mitigate risks, cultivate options, and lead the company through complex drug development decisions Oversees high-performing team of Program Managers, including direct management of the VP, Head of Program Management; driving achievement of company and program goals and the advancement of the company’s portfolio of programs ensuring effective cross-functional contributions from all company functions Oversees high-performing Clinical Operations team, including direct management of the VP, Head of Clinical Operations, and overall accountability for team based in US and EU; drives exceptional planning, start-up, conduct and close-out of Dyne clinical studies in line with corporate goals Articulates and drives the vision for how to build and scale the PTL, PM and Clin Ops organizations, capabilities, processes and infrastructure to support Dyne future growth As a member of Dyne Executive Committee, the Head of PS&amp;O partners with Dyne executive leadership team to integrate and harmonize Business Operations across the organization, driving portfolio level cross-program and cross-functional integration, coordination and operations across Dyne: Oversees Dyne governance, partnering with executive leadership to ensure timely, high-quality and cross-functional decision-making and information sharing to enable advancement of Dyne portfolio and programs Partners on the Dyne strategic planning process with CFO, ensuring development of robust program and project long- and short-range plans in line with corporate goals and resources Partners with CMO to build out integrated Development Operations capabilities to enable growth of late-stage development programs and the expansion of Dyne’s clinical pipeline. Oversees development of non-program operations to ensure harmonization and alignment of project management discipline and methodology across organization Key Responsibilities of the Role:&nbsp; Lead and develop team of Program Team Leaders and Program Managers to effectively advance Dyne Programs and foster seamless integration and communication across the company: Drive understanding and inspire the big picture thinking of corporate, portfolio and program strategy and cross-functional interdependencies in order to lead execution across all Programs Partner with Program Team Leaders to provide strategic and operational leadership to programs to achieve Program and company goal Ensure effective partnership with cross-functional representatives to develop comprehensive product development, commercialization and lifecycle management plans that optimize: value, time, resources, risk, and alignment with business objectives Oversee and enable high-performing cross-functional Program Teams, focusing on both the "what", such as strategy, priorities, output, and resources, and also the "how", such as maintaining a fulfilling, collaborative, and sustainable team environment Establish a robust and well-understood Program strategy for bringing a life-changing medicine to patients in need Effectively manage the Program Team model at Dyne: Develop and maintain clear Program plans understood by all team members with all key activities, deliverables, responsibilities, and timing Enable clear strategic decision making (articulate and align on timing and approach for key decisions; prepare effective analyses and materials for decisions; ensure decisions are understood and implemented), scenario planning and options analysis Ensure “health” of PT and Sub-Teams by proactively managing members’ engagement, communications, expectations, issue resolution, etc. Develop foundations for effective Portfolio Management (integrated portfolio views; key milestones and decisions; portfolio scenarios for effective optimization) Develop, maintain and make available Portfolio views in synch with Program plans and Dyne financials plans Drive Portfolio Review preparation and decisions Partner and Support yearly financial planning and LRP work Lead and develop Clinical Operations team to effectively advance Dyne portfolio of clinical studies: Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed to a high degree of quality across all clinical stage programs Develop and implement a clinical vendor oversight process with documentation to record transfer of regulatory responsibilities, evaluation of performance, and escalation of issues Establish, implement, and proactively manage clinical trial processes, strategic outsourcing, and performance indicators Ensure high standards for compliance and quality within the Clinical Operations team and across clinical trial vendors with company SOPs,&nbsp; ICH-GCP guidelines that govern regulations, and patient safety standards Regularly report clinical trial status, identify challenges and program/resource gaps, and devise and implements solutions Provide strategic input to clinical-trial related risk analysis and mitigation strategies Oversee the development and review of clinical program budgets, and track and forecast spend for initiated studies Lead or oversee the authorship of Clinical Operations SOPs and other function-specific documentation; participate in cross-functional SOP development and infrastructure initiatives Knowledge &amp; Skills Experience in Phase 1-3 drug development is required; product launch/early commercialization experience a strong plus Proven and respected leader with: Advanced degree in Medical or Life Science, MD, PhD or MBA or equivalent 15+ years of experience in pharmaceutical industry in leadership positions in drug development and proven track record in driving Programs through IND, early clinical, pivotal stages and approval And/or at least 12 years in pharmaceutical industry in significant development and/or commercial leadership or general management positions including working with development teams in cross-functional setting, with exceptional track record of delivering on business objectives, activity/milestones leading to filing and launching, and strong knowledge of neuromuscular diseases Experience in rare genetic diseases preferred Previous Clinical Operations functional and/or program leadership, including hiring and managing Clinical Operations staff, selecting and managing vendors/CROs, and optimizing resources across clinical studies Other Key Traits Include: Business-oriented leader, able to shape and communicate the vision for the Dyne portfolio and programs and guide the development of the product strategy and its execution Natural focus on team dynamics; insightful people leader supporting and coaching high-caliber functional experts to achieve their absolute best Demonstrated experience in building highly effective teams and guiding teams and organizations in making complex and high-stakes data-driven decisions Outstanding sense of urgency and ability to pace the team’s work to achieve milestone achievement in highly competitive environment Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams Comfort with ambiguity and ability to provide steadiness and consistency in environment of shifting priorities, demands and timelines &nbsp; &nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

SVP, Head of Portfolio Strategy and Operations

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The US Marketing Brand Lead is an experienced and hands-on strategic thinker who defines US brand strategy across HCP and Patient communities in neuromuscular disease. This position is a unique opportunity to drive the success of best-in-class treatments from the early stages of market introduction. You will be responsible for the strategic development and execution of the brand strategy, ensuring alignment with the company’s vision and the specific therapeutic needs of the target population. You will work cross-functionally with commercial leadership and peers in Field, omnichannel engagement, Market Access, Patient Advocacy, and Medical Affairs.&nbsp; As part of a high performing team, this role seamlessly collaborates cross functionally to deliver a one Dyne approach, including close collaboration with Field roles, Medical Affairs, Patient Services, Advocacy, and Market Access to ensure cohesive and aligned go-to-market strategies and successful execution. This is a unique opportunity for an exceptional marketer, strategic thinker, and commercial leader to play a key role on the US Marketing team.&nbsp; This role is based in Waltham, MA without the possibility of being a remote role.&nbsp; &nbsp;Primary Responsibilities: &nbsp; Develop and execute brand strategies and campaigns that elevate and drive product uptake and utilization at launch and beyond&nbsp; Lead development of value proposition, disease awareness, and promotional campaigns in collaboration with cross-functional partners&nbsp; Develop compelling messaging and programing to patients and caregivers, through close collaboration with patient advocacy team&nbsp;&nbsp; Select and direct a creative agency partner in development of disease awareness and promotional materials.&nbsp;&nbsp; Identify and execute personal and non-personal (e.g., digital) promotional tactics to optimize efficient reach to physicians and patients.&nbsp; Drive innovation in commercial strategy and tactics to build brand awareness, excitement, and intent to prescribe while ensuring superior execution of market development efforts&nbsp; Leverage market research, data, and customer insights to inform brand strategy and tactical decisions&nbsp; Working closely with Insights &amp; Analytics to support any message testing, market research, and insight generation&nbsp; Engage with thought leaders and maintain a strong understanding of scientific literature and disease landscape&nbsp; Maintain a strong relationship with field leadership and field teams; manage field advisory boards to understand key brand challenges and opportunities&nbsp; Manage and oversee brand-specific budgets&nbsp; Support definition, and achievement, targets, KPIs, and metrics including for HCP adoption, advocacy, and advocacy mobilization&nbsp; Provide leadership, motivation, and direction to cross-functional teams to achieve brand and audience goals&nbsp; Coordinating with the US Marketing Team on tactics with global reach, including Congresses, KOL engagement, Education, Awareness, and digital initiatives&nbsp; Working closely with legal to champion the compliance interface for commercial, ensuring appropriate governance, tracking and signoffs are in place for all commercial activities and materials (with support from cross-functional partners)&nbsp; Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; The successful candidate should be a dynamic individual with proven abilities as a biopharma commercial leader. S/he will have led successful product launches, driven revenue growth, have a strong reputation for excellent cross-functional collaboration and possess the following: &nbsp; Demonstrated brand and marketing expertise with experience developing comprehensive brand strategies in pharmaceutical or biotech companies&nbsp; Proven track record of successfully launching and commercializing biotech products, with a strong understanding of the unique challenges and opportunities in the rare disease market&nbsp;&nbsp; Strong track record of cross-functional leadership in high-growth environments, including setting expectations and delivering above plan.&nbsp; BA/BS degree required; advanced degree (MBA, PhD, PharmD) preferred&nbsp; Minimum 8-10 years’ experience in a in biopharmaceutical marketing and operational experience&nbsp; Enterprise mindset that makes culture and values come to life in everyday activities&nbsp; Experience in a small, rapidly growing biotech with the ability to operate and maneuver in a start-up environment while keeping a solutions-oriented mentality&nbsp;&nbsp; Ability to collaborate with ex. U.S. colleagues in aligning on marketing objectives and key strategies&nbsp; Demonstrates an authentic willingness and capability to roll up sleeves rather than relying on others for delivery&nbsp; Ability to travel as requested&nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

US Marketing Brand Lead

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: Dyne is seeking a Senior Research Associate, Platform Development, to help generate and advance the company’s therapeutics research and support its drug discovery programs. The Senior Research Associate, Platform Development, will be responsible for developing and executing analytical assays to characterize a variety of therapeutic candidates, collaborating closely with the platform group and colleagues across research to advance Dyne’s product pipeline and platform, and helping to establish and contribute to the operations of the company’s laboratories. Primary Responsibilities Include: Independently perform qualitative/quantitative LC-MS and other analytical/chromatography and biochemical assays for the characterization of various research materials Develop suitable analytical HPLC and LC-MS methods for proteins, peptides, and oligonucleotides in support of the Platform group Perform assays to analyze the stability, potency, purity, and efficacy of therapeutic materials Present research findings to cross-function project teams Contribute to critical discussions of therapeutic structure, function, and targets This role is based in Waltham, MA, without the possibility of being a hybrid role. Education &amp; Experience Requirements Either: Bachelor’s Degree or equivalent in Biochemistry, Chemistry, Pharmaceutical Sciences, or closely related and 4 years of hands-on industry experience in drug discovery and development, including: 4 years using liquid chromatography (e.g., SEC, IEX, RP, HIC, HILIC) and mass spectrometry analytical techniques and method development strategies 4 years performing protein, oligonucleotide, and/or small molecule LC-MS analysis (mass determination, intact mass analysis) 3 years using mass spectrometry and FLD/UV analysis software (BioPharma Finder, Empower) 4 years with protein quantification and binding assays (SDS PAGE, Western blotting, ELISA, UV Vis) Or: Master or higher degree or equivalent in Biochemistry, Chemistry, Pharmaceutical Sciences, or closely related and 2 years of hands-on industry experience in drug discovery and development, including: 2 years using liquid chromatography (e.g., SEC, IEX, RP, HIC, HILIC) and mass spectrometry analytical techniques and method development strategies 2 years performing protein, oligonucleotide, and/or small molecule LC-MS analysis (mass determination, intact mass analysis) 2 years using mass spectrometry and FLD/UV analysis software (BioPharma Finder, Empower) 2 years with protein quantification and binding assays (SDS PAGE, Western blotting, ELISA, UV Vis) And demonstrated proficiency in: Documenting experiments using electronic laboratory notebooks or similar systems Developing molecule-specific experimental workflows for characterization Maintaining and supporting a functioning analytical chemistry laboratory (instrument maintenance, buffer and mobile phase preparations, troubleshooting routine tasks) &nbsp; $113,297.72 USD The salary reflects the base pay Dyne reasonably expects to pay for this role at the time of posting &nbsp; #LI-DNIMA Pay Range$113,297.72&mdash;$113,297.72 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Research Associate, Platform Development

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Director of Trade and Distribution will bring their extensive market access experience to our first product launches in neuromuscular disease with an initial focus on launch readiness and commercialization of our lead assets in Duchenne Muscular Dystrophy and myotonic dystrophy Type I (DM1). The Director of Trade &amp; Distribution is responsible for managing and executing the distribution and channel strategy in the pre-launch, launch, and post-launch phases. This position will implement and manage all contracts with the 3PL, Specialty Distributors, Specialty Pharmacies, and other channels as needed. They will collaborate with Finance, Legal, Marketing, Sales, Market Access, Patient Services, Commercial Operations, Analytics, Quality, Supply Chain, and others as necessary. This position is critical to ensuring Dyne has the most efficient and seamless way possible of reaching our patients living with these severe diseases. A successful candidate is a self-starter who is highly driven, collaborative, and embodies values such as bold thinking, agility, and a focus on execution. &nbsp;S/he will have led successful product launches, driven revenue growth, have a strong reputation for excellent cross-functional collaboration&nbsp; As part of a high performing team, this role seamlessly collaborates cross functionally to deliver a one Dyne approach, including close collaboration with field roles, Marketing, Medical Affairs, Patient Services, Global Value and Access, and Advocacy, to ensure cohesive and aligned go-to-market strategies and successful execution. This is a unique opportunity for an exceptional strategic thinker and commercial leader to play a key role on the US leadership team.&nbsp; This role may be remote or based in Waltham, MA.&nbsp; &nbsp;Primary Responsibilities: &nbsp; Develop, lead, and implement the strategy of the trade and distribution approach.&nbsp; Partner with the payer team to ensure the distribution channel strategy meets the needs and expectations of the payer community and sites of care.&nbsp; Execute strategy and operationalize 3PL, wholesalers/specialty distributors, and specialty pharmacies to ensure availability and support for Dyne products.&nbsp; Collaborate with legal, finance and other internal operations functions to draft, execute, and implement, innovative compliant contracts with key trade and distribution partners to ensure business objectives are met.&nbsp; Monitor services agreements to ensure compliance and hold partners accountable to agreements.&nbsp; Partner with Patient Support, Marketing, Commercial Analytics and Sales to continually monitor, assess and evolve the distribution strategy and tactics to ensure objectives are met and exceeded.&nbsp; Identify, develop, and execute on practical compliance/adherence and other patient support programs that use our distribution and trade partners in collaboration with Dyne’s Patient Support Services team.&nbsp; Lead and manage channel engagement with all stakeholders associated with 3PL, Specialty Distribution, and Specialty Pharmacy/Specialty Infusion Providers. Develop and maintain relationships to ensure unfettered access to key personnel.&nbsp; Work with channel partners to ensure proper purchasing, stocking, and inventory to achieve corporate goals in a compliant manner. Continually monitor weekly sales to ensure purchases are aligned with demand and highlight any discrepancies to be investigated.&nbsp; Develop and implement performance metrics and tools such as dashboards and communicate results internally.&nbsp; Partner with Patient Support, Managed Markets, Finance, and Supply Chain to develop an appropriate return goods policy. Implement this policy within the distribution channel where necessary and monitor to ensure compliance and that appropriate objectives are met or exceeded.&nbsp; Spearhead an Infusion center/Site of Care distribution strategy&nbsp; Work cross-functionally with the manufacturing/supply chain and quality team on chain-of-custody and inventory tracking.&nbsp; Perform trade data reporting requirements in conjunction with commercial analytics to perform assessments in trade and network performance.&nbsp; Prepare and conduct quarterly business reviews with trade partners.&nbsp; Lead State Licensing initiatives.&nbsp; Lead budget and vendor management to ensure timely and fiscally responsible project execution.&nbsp; Support and provide Commercial input into CMC Supply Chain strategy and planning&nbsp; Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; BA/BS degree required; advanced degree (MBA, PhD, PharmD) preferred&nbsp; 12+ years of bio/pharmaceutical experience required with a key understanding of current US pharmaceutical distribution models&nbsp; 8+ years of US channel management experience (3PL, Specialty Distribution, Specialty Pharmacy)&nbsp; Previous rare disease experience and Buy-and-Bill models, including infusion products, preferred.&nbsp; Experience partnering with Specialty Pharmacies to establish fee-for-service programs&nbsp; Demonstrated experience in process development for coordination with HUB, co-pay, and other patient service providers&nbsp; A strong understanding of the policies, regulations, and compliance issues surrounding Trade and Distribution.&nbsp; Demonstrated skills in business planning and distribution strategy with strong problem-solving skills&nbsp; Demonstrated negotiation skills and financial acumen required to manage complex contractual agreements&nbsp; Lead strategy development, design, vendor selection, and implementation phases for end-to-end channel partnership&nbsp; Ability to translate and compile data into comprehensive and functional reports&nbsp; New product launch experience required&nbsp; Influential personality with the ability to simplify and clarify complex issues to broad and diverse audiences&nbsp; Enterprise mindset that makes culture and values come to life in everyday activities&nbsp; Experience in a small, rapidly growing biotech with the ability to operate and maneuver in a start-up environment while keeping a solutions-oriented mentality &nbsp; Demonstrates an authentic willingness and capability to roll up sleeves rather than relying on others for delivery&nbsp; Ability to travel to meet business objectives &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Trade & Distribution

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: Dyne is seeking a Senior Research Associate, CMC Process Sciences, to be responsible for internal process development of oligonucleotide conjugates and provide technical support for validation activities. The Senior Research Associate, CMC Process Sciences, will provide hands-on contributions to process establishment, process development, process characterization, and validation, and collaborate with other functions within the company including, but not limited to, analytical method development, quality control, and platform research, and directly participate in pre-clinical development and activities directly related to process validation of company’s clinical assets. Primary Responsibilities Include: Drug substance process development, including bioconjugation chemistry, purification, and analytical development Lead internal CMC Process Development activities via hands-on contribution in the lab Partner with Research to support bioconjugation development activities and enhance the tech transfer process to external manufacturing partners Represent CMC and Process Sciences as a technical leader in internal cross-functional teams Establish clear expectations and priorities, set objectives, and effectively apply resources to deliver on program goals Contribute creative ideas and new innovations that enable better products and processes. This role is based in Waltham, MA, without the possibility of being a hybrid role. Education &amp; Experience Requirements Master’s degree or higher in pharmaceutical sciences, biochemistry, or chemistry, or a closely related field 1 year in Research &amp; Development in a biopharmaceutical company. Experience must include: (1 year) working with bioconjugates including demonstrating a deep understanding of conjugation chemistries, preparative chromatography, and TFF (1 year) using analytical techniques for characterization of conjugates including HPLC/UPLC, SEC, SDS-PAGE, ion exchange chromatography, UV/vis, and LC-MS &nbsp; #LI-DNI MA Pay Range $120,712.22—$120,712.22 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Research Associate, CMC Process Sciences

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director of&nbsp;QA GMP&nbsp;Operations&nbsp;is responsible&nbsp;for&nbsp;management&nbsp;of&nbsp;GMP quality within our&nbsp;external&nbsp;manufacturing operations&nbsp;globally&nbsp;and internal GMP operations&nbsp;for development and commercial&nbsp;programs.&nbsp;The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes&nbsp;to advance programs within compliance.&nbsp;&nbsp;The Director&nbsp;is responsible for&nbsp;oversight of&nbsp;QA&nbsp;activities&nbsp;and&nbsp;ensuring the quality of deliverables within the role's purview.&nbsp;&nbsp; This is an onsite role based in Waltham, MA. &nbsp;Primary Responsibilities&nbsp;Include:&nbsp; Management of&nbsp;external quality operations in support of GMP manufacturing (clinical&nbsp;and&nbsp;commercial) activities.&nbsp; Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines.&nbsp; Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.&nbsp; QA support&nbsp;of&nbsp;Tech Transfer and Process Validation activities.&nbsp; Disposition of&nbsp;GMP&nbsp;batches&nbsp;and interfacing with the Qualified Person (QP).&nbsp; Change&nbsp;management to ensure proper evaluation of&nbsp;manufacturing and testing&nbsp;related changes&nbsp;by&nbsp;Quality, Regulatory, and Subject Matter Experts.&nbsp; Manage&nbsp;CDMO performance&nbsp;within&nbsp;Quality Agreement expectations&nbsp;and GMP compliance.&nbsp;&nbsp; Drive&nbsp;continuous&nbsp;improvement&nbsp;and&nbsp;inspection&nbsp;readiness.&nbsp;&nbsp; Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities&nbsp;are&nbsp;completed&nbsp;at the CDMOs&nbsp;and internally.&nbsp;&nbsp; Adjudicate on&nbsp;compliance discussions and negotiate any required corrective actions.&nbsp; Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence.&nbsp; Education and Skills Requirements:&nbsp; Minimum of a BA/BS degree&nbsp; Minimum of 10+ years of experience&nbsp;in GMP Quality Operations&nbsp;in a&nbsp;clinical late stage and/or commercial biotechnology&nbsp;company&nbsp; Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and&nbsp;allocate&nbsp;resources&nbsp;without direct authority&nbsp; Experience implementing and&nbsp;utilizing&nbsp;various outsourcing and support models&nbsp; Experience with&nbsp;disposition of&nbsp;product batches and interfacing with a&nbsp;Qualified Person&nbsp;(QP)&nbsp; Excellent written and oral communication skills, including well-developed presentation skills&nbsp; Excellent organizational skills&nbsp;and&nbsp;ability to manage multiple priorities&nbsp; Strong collaboration&nbsp;and interpersonal&nbsp;skills to effectively interact with internal or external stakeholders at all levels in the organization&nbsp; General business management knowledge to assess the impact of project decisions on financial and corporate objectives&nbsp; Ability to drive&nbsp;timelines, meet firm&nbsp;deadlines,&nbsp;and adapt quickly to changing requirements and priorities&nbsp; Embrace Dyne’s core values and culture&nbsp; &nbsp; #LI-OnsiteMA Pay Range$188,000&mdash;$230,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, QA GMP Operations

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Manager, Supply Chain Planning&nbsp;is responsible for&nbsp;end-to-end inventory and production planning across Dyne’s external supply network. This includes long-range planning (LRP), ensuring uninterrupted clinical supply, and supporting commercial launch readiness through scenario-based planning and risk assessments. This tactical role is critical in executing current planning activities and shaping future supply chain capabilities. The Manager collaborates cross-functionally with internal stakeholders (e.g. the wider CMC team, Regulatory, Quality, Clinical Operations, and Commercial teams) as well as external partners and service providers.&nbsp;&nbsp; This is a full-time position based&nbsp;in Waltham, MA&nbsp; Primary Responsibilities&nbsp;Include:&nbsp; Production Planning&nbsp; Collaborate with cross-functional partners in Technical Operations, Logistics, Quality, Clinical Operations, and Commercial to develop and&nbsp;maintain&nbsp;a reliable demand and supply plan, ensure supply continuity, uninterrupted clinical supply for patients, support commercial readiness, and align with the company’s business&nbsp;objectives.&nbsp;&nbsp; Maintain an understanding of external manufacturing site capacities, capabilities, and supply risks.&nbsp; Perform scenario planning to evaluate alternative demand and supply assumptions and inform risk mitigation strategies.&nbsp; Maintain vendor forecasts in alignment with clinical and commercial demand forecasts as well as contracted minimum production requirements.&nbsp;&nbsp; Balance production across supply network to&nbsp;maintain&nbsp;set inventory targets&nbsp; Manage master data, demand forecasts, and&nbsp;accurate&nbsp;stock levels in&nbsp;SCmple&nbsp;Supply Chain Planning tool.&nbsp; Manage purchase orders and invoice reconciliation from external vendor network.&nbsp; Support the Implementation of an&nbsp;Enterprise Resource Planning (ERP) system.&nbsp; Logistics Operations Support&nbsp; Coordinate and oversee shipments of materials between CMOs, warehouses, 3PLs, Test Labs and other supply chain nodes.&nbsp; Support network re-supply, working closely with internal stakeholders (Quality, Manufacturing) and external partners (couriers, CMOs, customs brokers, and warehouse providers).&nbsp; Ensure&nbsp;timely&nbsp;and compliant shipments, including documentation preparation, booking, tracking, and post-shipment follow-up,&nbsp;closure&nbsp;and archiving.&nbsp; Troubleshoot&nbsp;logistics&nbsp;issues and implement corrective actions as needed.&nbsp; Compliance &amp; Documentation&nbsp; Ensure all planning and&nbsp;logistics&nbsp;activities are conducted in compliance with GMP, GDP, and other applicable regulations.&nbsp; Author, implement and&nbsp;maintain&nbsp;the necessary Supply Chain-related standard operating procedures (SOPs) and work instructions.&nbsp; Collaborate with Quality and Regulatory teams to ensure proper handling of clinical and commercial materials.&nbsp; Collaborate with cross-functional teams to&nbsp;establish&nbsp;processes and capabilities to support ongoing clinical operations and future commercial operations.&nbsp; &nbsp; Education, Experience,&nbsp;and Skills Requirements:&nbsp; Bachelor’s degree in Life Sciences, or related field; Advanced degree or certification is a plus&nbsp;&nbsp; 5 years total experience, 3+ years in supply chain planning, preferably within the pharmaceutical or biotech industry&nbsp;&nbsp; Ability to effectively plan, prioritize, execute, follow&nbsp;up&nbsp;and&nbsp;anticipate&nbsp;challenges&nbsp;&nbsp; Experience managing complex schedules and priorities in dynamic pharmaceutical,&nbsp;biotech&nbsp;or related environments&nbsp;&nbsp; Ability to work, influence, and gain agreement across multiple functions&nbsp;&nbsp; Strong analytical, problem solving, and critical thinking skills&nbsp;&nbsp; Experience with ERP system implementation&nbsp;&nbsp; Proficiency&nbsp;in Excel and familiarity with planning and analytics tools such as Smartsheet, Visio, ERP systems (e.g., SAP, Oracle), and Power BI&nbsp;&nbsp; Collaborative work style to be part of a team to&nbsp;identify&nbsp;process gaps and develop solutions&nbsp;&nbsp; Excellent interpersonal, verbal, and written communication skills&nbsp;&nbsp; Experience supporting clinical and/or commercial supply chains&nbsp;&nbsp; Operational experience managing material movements across global CMOs, 3PLs, warehouses, and Test Labs&nbsp;&nbsp; Working knowledge of GMP/GDP standards&nbsp;&nbsp; Proactive problem solver with the ability to&nbsp;operate&nbsp;independently in a fast-paced environment&nbsp;&nbsp; High attention to detail and organizational skills&nbsp;&nbsp; Ability to manage multiple priorities and stakeholders simultaneously&nbsp; &nbsp; &nbsp; &nbsp; #LI-OnsiteMA Pay Range$122,000&mdash;$150,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Manager, Supply Chain Planning

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Medical Science Liaison&nbsp;(MSL)&nbsp;is an&nbsp;experienced field medical expert who plays a strategic role&nbsp;on&nbsp;the field medical team with depth and breadth of business acumen, therapeutic knowledge and serves as an informal leader on the team.&nbsp;The person in this role&nbsp;is&nbsp;a customer&nbsp;facing,&nbsp;field-based extension of our Medical Affairs team.&nbsp;The MSL’s key&nbsp;objective&nbsp;is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes.&nbsp;This individual serves&nbsp;as a key scientific resource, engaging with healthcare professionals (HCPs), key opinion leaders (KOLs), and other stakeholders to provide scientific and clinical support for our portfolio.&nbsp;&nbsp; This is a field-based role. Primary Responsibilities&nbsp;Include:&nbsp; Builds awareness of the company within the medical community and develops strategic KOL/territory engagement plans aligned with the medical strategy&nbsp;&nbsp; Supports clinical research (investigator-initiated and company-sponsored), speaker development, and training as needed&nbsp;&nbsp; Demonstrates thorough knowledge of the company, its investigational products, and current medical research&nbsp;&nbsp; Maximizes attendance at national and regional conferences to gather insights, assess the competitive landscape, and strengthen relationships&nbsp;&nbsp; Collaborates cross-functionally (clinical, regulatory, market access) to advance business and scientific goals&nbsp; Develops&nbsp;and&nbsp;executes&nbsp;regional medical strategies in alignment with company goals&nbsp; Leads&nbsp;KOL engagement strategies and&nbsp;identifying&nbsp;new scientific leaders&nbsp; Demonstrates business acumen within therapeutic area and understands broader organization and competitive landscape&nbsp; Leads identification and mapping of key KOLs within the therapeutic area, driving engagement strategies&nbsp; Provides strategic leadership within the MSL team as a peer leader, motivator, and problem solver&nbsp; Manages top-tier KOL relationships, synthesizes high-level medical insights, and informs company&nbsp;medical&nbsp;strategies&nbsp; Mentors junior MSLs and contributes to team strategy development&nbsp; Acts as a subject matter expert for internal stakeholders, including marketing, sales, and clinical teams&nbsp; Collaborates with internal teams (HEOR, access, marketing, sales) to&nbsp;maintain&nbsp;a customer-centric, compliant approach&nbsp;within assigned territory&nbsp; Establishes and develops HCP relationships, engaging in activities such as data discussions, clinical trials, and addressing patient journey barriers&nbsp; Responds to unsolicited information requests in&nbsp;a timely,&nbsp;accurate, and compliant manner&nbsp; Ensures compliant dissemination of scientific&nbsp;and clinical&nbsp;information to healthcare providers&nbsp; Manages administrative tasks (e.g., Veeva CRM, expense reports, compliance modules) efficiently, including customer profiling and keeping CRM information up to date&nbsp; &nbsp; Education&nbsp;and Skills Requirements:&nbsp; Advanced scientific degree or equivalent&nbsp;required&nbsp;(e.g., MD, PhD,&nbsp;NP, PharmD,&nbsp;PA)&nbsp; 10+ years of MSL&nbsp;experience is preferred Clinical experience within neuromuscular disorders (e.g., DMD, DM1) preferred; rare disease experience considered&nbsp; Strong knowledge of investigational products and the neuromuscular space, including emerging data&nbsp; In-depth understanding of clinical trial and investigator-sponsored study processes&nbsp; Proven ability to work effectively within multidisciplinary teams&nbsp; Clear understanding of MSL role and responsibilities&nbsp; Skilled in building and&nbsp;maintaining&nbsp;relationships with KOLs through scientific&nbsp;expertise&nbsp;and follow-through&nbsp; Ability&nbsp;to communicate research results clearly to diverse&nbsp;audiences&nbsp; Strong communication&nbsp;skills (written, verbal, presentation) for building relationships with colleagues&nbsp; Ability to influence without authority at all levels of the organization and externally&nbsp;&nbsp; Expert in planning, prioritizing, and executing tasks efficiently&nbsp; Capable of working independently and managing time in a home office&nbsp; Adaptable in ambiguous and dynamic environments&nbsp; Leverages past neuromuscular relationships to support study enrollment and site communication&nbsp; Experienced in relationship building to expand company reach&nbsp; Experience with relationship building and expanding a company’s reach&nbsp; Must be willing to travel extensively and occasionally on weekends&nbsp; Positive team member who embodies the Dyne Core Values&nbsp; Excitement about Dyne’s vision and mission&nbsp;&nbsp; Must be willing to travel extensively and occasionally on weekends &nbsp;MA Pay Range$183,000&mdash;$255,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Medical Science Liaison - East

Medical Science Liaison - North

Medical Science Liaison - South

Medical Science Liaison - West

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Senior Manager Clinical Supply manages, and monitors activities related to ongoing clinical trial operations and systems to ensure supply continuity. In addition, the role supports readiness of the clinical label and pack set up, global trial distribution network and clinical trial systems for upcoming clinical studies.&nbsp;&nbsp; The Senior Manager closely&nbsp;interfaces&nbsp;Clinical Operations, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Organization (CMO), Contract Research Operations (CRO’s)&nbsp;and clinical sites to ensure clinical trial supply material is available as&nbsp;required&nbsp;and readiness of the clinical supply network work support the clinical trial strategy. The clinical supply team also provides critical input to&nbsp;set&nbsp;the clinical trial strategy.&nbsp;&nbsp; This is a full-time position based&nbsp;in Waltham, MA&nbsp; Primary Responsibilities Include:&nbsp; Clinical Trial Supply&nbsp; Oversee clinical supply operations, including labeling, packaging, distribution, and resupply across global depots&nbsp; Manage depot and site inventory in collaboration with Trial Managers; ensure&nbsp;timely&nbsp;IMP and placebo shipments globally&nbsp; Coordinate labeling and packaging activities with Clinical CMOs and&nbsp;monitor&nbsp;international shipping and distribution&nbsp; Manage exceptions in Quality Systems (deviations, investigations, CAPAs, specifications, and change controls)&nbsp; Ensure readiness of labeling, packaging, and distribution networks for future trials&nbsp; Align with Supply Planning on demand forecasts, manufacturing outputs, and supply continuity; reconcile inventory and shipments monthly&nbsp; Lead development and updates of pharmacy manuals for Phase I–III trials; provide input to clinical strategy and study protocols&nbsp; Manage product returns, replacements, and destruction in collaboration with Clinical Operations and Quality&nbsp; Identify&nbsp;and implement process improvements; act as SME during regulatory audits&nbsp; Represent Clinical Supply on global project teams and collaborate cross-functionally to build capabilities&nbsp; Author and&nbsp;maintain&nbsp;SOPs and work instructions for inventory, IRT, labeling, distribution, returns, and destruction&nbsp; Network Logistics Support&nbsp; Coordinate shipments between CMOs, warehouses, 3PLs, test labs, and other nodes&nbsp; Support network resupply with internal teams and external partners (couriers, customs brokers, CMOs)&nbsp; Ensure compliant,&nbsp;timely&nbsp;shipments including documentation, booking, tracking, and closure&nbsp; Troubleshoot&nbsp;logistics&nbsp;issues and implement corrective actions&nbsp; Education, Experience,&nbsp;and Skills Requirements:&nbsp; BS/BA degree (Masters preferred) in life sciences or business major or equivalent&nbsp;required.&nbsp; 5+ years of related experience in the pharmaceutical or biotech industry with at least 3 years of direct experience in global clinical supply management.&nbsp; Experience leading contract manufacturing is&nbsp;required.&nbsp; Excellent interpersonal and organizational skills.&nbsp; Ability to work and influence across&nbsp;different functions&nbsp;and stakeholders&nbsp; High collaborative team-player who fosters open communication,&nbsp;facilitates&nbsp;mutual understanding, drives&nbsp;alignment&nbsp;and effectively&nbsp;maintains&nbsp;relationships with key internal and external stakeholders.&nbsp; Proven ability to manage external vendors&nbsp; Operational experience managing material movements across global CMOs, 3PLs, warehouses, and Test Labs.&nbsp; Proactive problem solver and self-directed individual with the ability to&nbsp;operate&nbsp;independently in a complex, fast-paced environment.&nbsp; Ability to set clear&nbsp;objectives, effectively plan, prioritize, and&nbsp;anticipate&nbsp;challenges and drive execution per plan.&nbsp;&nbsp; &nbsp; &nbsp; #LI-OnsiteMA Pay Range$143,000&mdash;$175,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Manager, Clinical Supply

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Clinical Trial Manager ensures that clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs). This position&nbsp;is responsible for&nbsp;initiating&nbsp;and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements. This position ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne’s policies and SOPs. This individual may&nbsp;be responsible for&nbsp;one medium complexity or multiple lower complexity clinical studies. This role may also support management of certain aspects of one or more high complexity studies led by a Clinical Study Lead.&nbsp;&nbsp; This role is based in Waltham, MA without the possibility of being a remote role. Primary Responsibilities Include: Manage, either independently or in partnership with COSL, all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations &nbsp; Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities &nbsp; Support the selection, oversight, and management of CROs and other vendors &nbsp; Monitor and assess vendor performance against contractual operational deliverables. &nbsp; Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors &nbsp; Provide oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track &nbsp; Participate in cross-functional teams and manage study team in partnership with the CRO &nbsp; Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities &nbsp; Participate in planning and conducting investigator meetings together with the CRO &nbsp; Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time &nbsp; Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data &nbsp; Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required &nbsp; Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances &nbsp; Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate &nbsp; Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always “inspection ready” &nbsp; Prepare high-quality reports and dashboards (financial, project, etc.) for senior management on program status and issues as required &nbsp; Education and Skills Requirements: Minimum of a B.A. or B.S. degree in life science or related discipline is required; advanced degree desirable&nbsp; Minimum of 3-5 years of clinical trial management experience in conducting Ph I-III International clinical trials in pharma/biotech organization&nbsp; Scientifically and clinically astute with very strong project management skills&nbsp; Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws&nbsp; Understand clinical study budgets, accruals and forecasting&nbsp; Experience with clinical studies in muscular dystrophies desirable&nbsp; Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously&nbsp; Understand technical, scientific and medical information, to plan, organize, project manage and analyze data&nbsp; Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships&nbsp; Experience in vendor selection and overseeing studies being managed by a CRO&nbsp; Ability to successfully engage and work collaboratively with clinical operations team members/colleagues&nbsp; Excellent interpersonal and decision-making skills&nbsp; Demonstrated innovation, possesses drive, energy and enthusiasm to deliver the program objectives&nbsp; Excellent planning, time management &amp; coordination skills&nbsp; Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs&nbsp; Experience in working in a small organization&nbsp; Ability to travel for up to 20% is required (including overnight stays and international travel)&nbsp; Excellent written and oral communication skills&nbsp; Full competency in Microsoft Office programs&nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Clinical Trial Manager

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Executive&nbsp;Director,&nbsp;Regulatory Affairs Advertising &amp; Promotion&nbsp;leads regulatory strategy and compliance for advertising and promotional activities across all external communications.&nbsp;This role serves as the subject matter expert, partnering with&nbsp;the launch team,&nbsp;commercial, medical affairs, R&amp;D, corporate communications, legal, and leadership to ensure messaging aligns with FDA regulations and company&nbsp;objectives.&nbsp;The person in this role&nbsp;provides&nbsp;strategic guidance on complex promotional claims,&nbsp;anticipates&nbsp;market and regulatory factors, and drives innovative, compliant solutions.&nbsp;This role chairs&nbsp;the&nbsp;regulatory review&nbsp;for&nbsp;the Promotion Review Committee&nbsp;(PRC)&nbsp;and&nbsp;for the Medical Review Committee (MRC), balancing legal requirements with business goals while mitigating risk across promotional campaigns and corporate communications.&nbsp; This role is based in Waltham, MA without the possibility of&nbsp;being a fully remote role.&nbsp;&nbsp; &nbsp;Primary Responsibilities&nbsp;Include:&nbsp; Serves as&nbsp;the&nbsp;subject matter expert for Regulatory Affairs Ad/Promo, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives&nbsp; Proactively&nbsp;identifies&nbsp;and evaluates fundamental issues, providing strategy and&nbsp;direction,&nbsp;anticipating&nbsp;factors that could influence strategies and company position in the market&nbsp; Leads&nbsp;the&nbsp;PRC&nbsp;to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance&nbsp; Serves as lead Regulatory Advertising &amp; Promotion expert on&nbsp;MRC&nbsp; Accountable for review and approval of external communications materials for promotion and scientific exchange, and corporate messaging in line with relevant goals and deliverables with a broad impact on the organization. When needed, delegates tasks effectively and appropriately to direct focus on strategic planning and execution&nbsp; Proposes creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business&nbsp;objectives&nbsp;and minimize risk&nbsp; Supports Commercial&nbsp;launch&nbsp;teams,&nbsp;participating&nbsp;in strategy discussions and extended team meetings&nbsp;to&nbsp;provide&nbsp;regulatory guidance and perspective on marketing strategies and promotion&nbsp;objectives&nbsp;and tactics&nbsp; Provides promotional regulatory input on concepts and draft materials to ensure they are aligned with promotional regulations, corporate standards and policies and business objectives&nbsp; Leads the development and implementation of guidelines and processes for the creation, review,&nbsp;approval&nbsp;and regulatory submission, where applicable, of external communications content&nbsp; Acts as the recognized authority on regulatory advertising and&nbsp;promotion&nbsp;matters. Able to work independently and deal with division or corporate functions, or with external agencies.&nbsp; Serves as&nbsp;primary Regulatory Advertising &amp; Promotion contact for Regulatory Agencies&nbsp; Actively&nbsp;participate&nbsp;in labeling and global regulatory team meetings to ensure support for&nbsp;anticipated&nbsp;promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it related to the use of study results in US and global promotion.&nbsp; Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement&nbsp;letters&nbsp;and policies issues affecting the pharmaceutical/biologics&nbsp;industry and&nbsp;Communicates&nbsp;significant changes in FDA perspective to relevant stakeholders.&nbsp; Contributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review&nbsp; Education and Skills Requirements:&nbsp; BS degree in scientific,&nbsp;clinical&nbsp;or related area&nbsp;required. Advanced degree&nbsp;highly&nbsp;desirable.&nbsp; 12+ years pharmaceutical/biotech industry experience with a minimum of 10 years of&nbsp;direct experience as primary Regulatory reviewer of advertising and promotional materials is&nbsp;required&nbsp; In-depth understanding of strategic regulatory advertising and promotion concepts as well as breadth of regulatory advertising &amp; promotion&nbsp;expertise&nbsp; Successful launch experience, preferably including global product launches&nbsp; Works comfortably with abstract ideas or situations across functional areas of the business&nbsp; Strong&nbsp;track record&nbsp;of implementing successful business strategies for branded and unbranded promotional campaigns&nbsp; Ability to see impact of decisions across various segments of the organization, including Medical Affairs and Corporate Communications activities.&nbsp; Strong interpersonal skills&nbsp;and&nbsp;proven negotiator&nbsp;with&nbsp;demonstrated&nbsp;ability to use constructive debate to&nbsp;identify&nbsp;and move others towards compliant promotional outcomes&nbsp; Ability to communicate and influence without authority at all levels of the organization and externally&nbsp; Well organized with exceptional communication skills, strong influencing skills, strong technical&nbsp;writing&nbsp;and documentation skills, as well as strong analytical and problem-solving skills&nbsp; Thinks innovatively and creatively,&nbsp;identifying&nbsp;the risks surrounding promotional claims and campaigns&nbsp;&nbsp; Proficient in computer applications and configurations including Microsoft Office Suite or related software, Veeva&nbsp;PromoMats&nbsp;and Veeva&nbsp;MedComms&nbsp;systems&nbsp; Demonstrated history of successful interactions with promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch&nbsp; Positive team member who&nbsp;embodies the Dyne Core Values&nbsp; Excitement about&nbsp;Dyne’s&nbsp;vision and mission&nbsp;&nbsp; MA Pay Range$250,000&mdash;$305,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Executive Director, Regulatory Affairs Advertising & Promotion

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The&nbsp;Medical Value&nbsp;Liaison&nbsp;(MVL)&nbsp;is an&nbsp;experienced field medical expert who plays a strategic role&nbsp;in&nbsp;the field medical team with depth and breadth of business acumen, therapeutic knowledge,&nbsp;and leader on the team.&nbsp;The person in this role&nbsp;is&nbsp;a customer&nbsp;facing,&nbsp;field-based extension of our Medical Affairs team.&nbsp;The&nbsp;MVL’s key&nbsp;objective&nbsp;is to create impact through advancing&nbsp;patient outcomes,&nbsp;medication&nbsp;access, and customer experience&nbsp;within&nbsp;an&nbsp;assigned&nbsp;set of national/regional&nbsp;payer&nbsp;accounts.&nbsp;This individual serves&nbsp;as a key scientific resource, engaging with healthcare decision-makers and&nbsp;other&nbsp;medication access&nbsp;stakeholders to provide scientific, health economic,&nbsp;and&nbsp;clinical support for our&nbsp;portfolio.&nbsp;&nbsp;&nbsp; This is a field-based role. Primary Responsibilities&nbsp;Include:&nbsp; Serves as medical lead, engaging&nbsp;in&nbsp;timely&nbsp;and compliant scientific, health&nbsp;economic,&nbsp;disease state exchange with payers and&nbsp;other&nbsp;healthcare decision makers&nbsp; Develops strategic&nbsp;customer&nbsp;account&nbsp;plans&nbsp;that are aligned with&nbsp;both&nbsp;medical&nbsp;and access&nbsp;strategies, including&nbsp;identifying&nbsp;and building relationships with key&nbsp;customers at&nbsp;payer&nbsp;organizations&nbsp;and&nbsp;other&nbsp;healthcare decision makers&nbsp;&nbsp; Gathers high-level&nbsp;customer&nbsp;insights that shape and inform company&nbsp;and access&nbsp;strategy&nbsp; Responds to unsolicited&nbsp;medical&nbsp;information requests in&nbsp;a timely,&nbsp;accurate, and compliant manner&nbsp; Serves as an internal subject matter expert and provides training&nbsp;as needed for Market Access&nbsp;team&nbsp;and other divisions&nbsp; Provides insight, input, and support towards the development of&nbsp;payer facing&nbsp;field tools and resources&nbsp; Builds awareness of the company within the payer and access community&nbsp; Supports&nbsp;internal&nbsp;health economic and outcomes&nbsp;research&nbsp;(HEOR)&nbsp;initiatives&nbsp;&nbsp; Demonstrates thorough knowledge of the company, its investigational products&nbsp;and current research,&nbsp;and payer landscapes&nbsp;impacting&nbsp;the&nbsp;company&nbsp;portfolio&nbsp;&nbsp; Attends key&nbsp;national and regional&nbsp;payer, HEOR, and medical&nbsp;conferences to gather insights, assess the competitive landscape, and strengthen relationships&nbsp;&nbsp; Provides strategic leadership within the team as a peer leader&nbsp;and mentor, motivator, problem solver, and contributes to&nbsp;the overall&nbsp;team strategy&nbsp; Collaborates with internal teams&nbsp;including&nbsp;Market&nbsp;Access,&nbsp;HEOR,&nbsp;MSLs,&nbsp;Patient&nbsp;Advocacy,&nbsp;Commercial,&nbsp;Legal,&nbsp;Compliance&nbsp;to&nbsp;maintain&nbsp;a customer-centric, compliant approach&nbsp;within assigned territory&nbsp;&nbsp; Manages administrative tasks (e.g., Veeva CRM, expense reports, compliance modules) efficiently, including customer profiling and keeping CRM information up to date&nbsp; &nbsp; Education&nbsp;and Skills Requirements:&nbsp; Advanced scientific degree or equivalent&nbsp;required&nbsp;(e.g.,&nbsp;PharmD,&nbsp;PhD,&nbsp;MD)&nbsp; 8+ years of&nbsp;experience&nbsp;in a&nbsp;relevant pharmaceutical&nbsp;industry, managed care,&nbsp;or&nbsp;HEOR&nbsp;role&nbsp; Experience&nbsp;as a payer&nbsp;focused&nbsp;field medical liaison&nbsp;and/or&nbsp;experience in account management, formulary management, trade/rebate, Director of Pharmacy,&nbsp;academic detailing,&nbsp;economic modeling/HEOR, etc.&nbsp; Experience with neuromuscular disorders (e.g., DMD, DM1), rare disease, specialty&nbsp;and accelerated approval drugs&nbsp;is highly desired&nbsp; Prior launch experience is a plus&nbsp; Strong understanding of the US payer system&nbsp; Proven ability to work effectively within multidisciplinary teams&nbsp; Skilled in building and&nbsp;maintaining&nbsp;relationships through scientific&nbsp;expertise&nbsp;and follow-through&nbsp; Able to&nbsp;master clinical and health economic data and&nbsp;communicate&nbsp;complex information in a concise and effective way&nbsp;across&nbsp;diverse audiences&nbsp; Effective communication&nbsp;skills (written, verbal, presentation)&nbsp;&nbsp; Expert in planning, prioritizing, and executing tasks efficiently&nbsp; Capable of working independently and managing time in a home office&nbsp; Adaptable in ambiguous and dynamic environments&nbsp; Must be willing to travel&nbsp;up to 60%, inclusive of overnight&nbsp;and occasional weekends&nbsp;to meet with customers, internal stakeholders, and attend relevant conferences&nbsp; Positive team member who embodies the Dyne Core Values&nbsp; Excitement about Dyne’s vision and mission&nbsp;&nbsp; MA Pay Range$183,000&mdash;$255,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Medical Value Liaison - Northeast

Medical Value Liaison - West / Southwest

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role&nbsp;Summary:&nbsp; The Manager, HR Operations &amp; Onboarding will&nbsp;partner with the HR team to&nbsp;continuously enhance Dyne’s core HR operational functions, including onboarding, HRIS administration, benefits coordination, and process optimization. This role will ensure&nbsp;a seamless&nbsp;and engaging experience for new hires,&nbsp;maintain&nbsp;data integrity across Dyne’s HR systems (ADP Workforce Now and Greenhouse ATS), and drive automation to enable scalability, efficiency, and&nbsp;a best-in-class employee experience.&nbsp; This role is based in Waltham, MA without the possibility of being remote.&nbsp; Key Responsibilities&nbsp; Support day-to-day HR operations, ensuring accuracy, efficiency, and compliance across onboarding, HRIS management, and benefits administration&nbsp; Oversee and&nbsp;optimize&nbsp;workflows within ADP Workforce Now and Greenhouse ATS, ensuring seamless data flow and system integration&nbsp; Design, manage, and continuously improve Dyne’s onboarding&nbsp;processes,&nbsp;systems,&nbsp;and programs to deliver an engaging and consistent new hire experience aligned with Dyne’s culture and values&nbsp; Serve as the first point of contact for&nbsp;general&nbsp;HR inquiries, providing&nbsp;timely&nbsp;and&nbsp;accurate&nbsp;support to employees and managers&nbsp; Ensure compliance with all employment-related documentation and recordkeeping requirements&nbsp; Collaborate closely with Talent Acquisition, IT, and HR Business Partners to streamline processes and enhance service delivery&nbsp; Partner with external vendors to manage&nbsp;Service Level Agreements&nbsp;and ensure high-quality service delivery&nbsp; Oversee contract lifecycle and&nbsp;purchase&nbsp;order management, including creation, tracking, and reconciliation, ensuring alignment with procurement policies and&nbsp;timely&nbsp;vendor invoicing and payment processing&nbsp; Identify, recommend, and implement automation or process improvements that enhance operational efficiency and employee experience&nbsp; Support HR policy development, ensuring alignment with Dyne’s culture and compliance with applicable laws and regulations&nbsp; Generate, analyze, and&nbsp;maintain&nbsp;accurate&nbsp;HR reports and dashboards by extracting data from HRIS and other systems to support strategic decision-making, compliance, and operational efficiency&nbsp; Own the&nbsp;data&nbsp;submission of compensation benchmarking reports&nbsp; Assist&nbsp;with immigration-related requests, documentation, and processes&nbsp; Assist&nbsp;with benefits administration&nbsp;&nbsp; &nbsp; Education and Skills Requirements:&nbsp; Bachelor’s degree in Human Resources, Business Administration, or a related field&nbsp; 5+&nbsp;years of HR operations experience, preferably within biotech, pharmaceutical, or high-growth life sciences environments&nbsp; Hands-on experience with ADP Workforce Now and Greenhouse ATS preferred&nbsp; Experience designing and managing onboarding programs that provide a seamless introduction to Dyne’s culture and mission&nbsp; Strong analytical and problem-solving skills with attention to detail and data accuracy&nbsp; Excellent communication and organizational skills, with the ability to manage multiple priorities&nbsp; Demonstrated curiosity, continuous improvement mindset, and ability to drive process innovation&nbsp; Sense of urgency and&nbsp;intrinsic motivation to drive projects, generate solutions/ideas, and&nbsp;build knowledge and&nbsp;expertise&nbsp;&nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Manager, HR Operations & Onboarding

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role&nbsp;Summary:&nbsp; The Vice President of Total Rewards, People Operations &amp; Analytics is Dyne’s enterprise owner for Compensation, Benefits, HR Compliance, HR Operations. and HRIS and People Analytics. As a key member of the HR Leadership Team, this leader will develop comprehensive total rewards and recognition programs, operations and analytics strategies that align to Dyne’s people philosophy and culture, build scalable programs and infrastructure, and serve as a key advisor to the CHRO and Compensation Committee to ensure Dyne’s rewards and people systems are competitive, equitable, compliant, and insight-driven.&nbsp; &nbsp;This is a strategic and hands-on leadership role that will ensure Dyne is a top employer by offering competitive compensation, meaningful benefits, and seamless people operations that enhance the employee experience.&nbsp; This role is based in Waltham, MA without the possibility of being remote.&nbsp; Key Responsibilities&nbsp; Compensation (executive &amp; broad-based)&nbsp; Own Dyne’s global compensation philosophy and frameworks (market positioning, pay mix, salary structures, job architecture, geographic differentials) Lead annual compensation planning (merit, promotions, adjustments), short- and long-term incentive design, sales/field comp as applicable, and equity strategy (grant guidelines, refresh cadence, burn rate/share pool stewardship) Partner with the CHRO to prepare materials for and present to the Board Compensation Committee; provide external benchmarking, pay-for-performance insights, and risk/compliance guidance Maintain competitive market intelligence (surveys, biotech equity practices), and advise on underwater equity, refresh approaches, and executive offers/retention mechanisms &nbsp;Benefits, Wellbeing &amp; Leaves&nbsp; Own&nbsp;strategy and administration of health &amp; welfare plans, retirement, time-off/leave&nbsp;programs, and wellbeing&nbsp;offerings that reflect our patient-centric culture and growth stage Lead annual plan design/renewals, vendor management, fiduciary compliance, communications, and required testing/reporting&nbsp;&nbsp; Ensure benefits and wellness programs align to biotech peer standards for attraction/retention &nbsp;People Operations (HR Ops)&nbsp; Lead Dyne’s People Operations function with a particular focus on&nbsp;ADP Workforce Now (WFN) as our core HRIS/payroll/benefits platform: oversee system configuration, integrations, access control, data flows, maintenance, and upgrades&nbsp; Ensure ADP WFN and integrated modules (HR, payroll, benefits, talent, time &amp; attendance) support process scalability and data integrity Stand up or refine processes across the employee lifecycle (hire-to-retire), including onboarding/offboarding, employee records, policy execution, compliance, and multi-state/global payroll in partnership with Legal/Finance Own vendor ecosystem (benefits administration, brokers, payroll, HR tech); negotiate SLAs and performance Deliver operational excellence that improves employee experience while ensuring accuracy, audit readiness, and regulatory compliance Drive continuous innovation and intelligent automation across all HR systems and processes to enhance scalability, efficiency, and data accuracy as Dyne grows &nbsp; People Analytics &amp; Workforce Insights&nbsp; Build Dyne’s&nbsp;people analytics strategy and operating model with data pulled from ADP WFN and integrated sources—standardize definitions, data pipelines, secure governance, and self-serve dashboards Provide recurring, decision-grade insights: headcount planning, hiring funnel analytics, DEI metrics, rewards effectiveness, engagement/retention risk, organization health, and productivity Partner with Finance on workforce planning, scenario modeling, and budget alignment &nbsp;Leadership &amp; Governance&nbsp; Lead and scale the team across Total Rewards, People Ops (especially the ADP domain), and Analytics;&nbsp;establish clear operating rhythms and SLAs&nbsp; Serve as thought partner to CHRO/CFO and a credible voice with the Compensation Committee Ensure policies and practices are compliant,&nbsp;equitable, and consistent with Dyne’s values and patient-first mission &nbsp; Education and Skills Requirements:&nbsp; Bachelor’s required; MBA/MS HR/Analytics preferred CEP, CCP, CBP, SHRM-SCP/CEBS helpful for depth in comp/benefits and governance 15+ years in HR with deep leadership in Total Rewards, specifically global&nbsp;compensation&nbsp;and benefits.&nbsp;&nbsp;Biotech/pharma experience is highly preferred Expert knowledge of executive and broad-based compensation (market pricing, incentive/Equity design, job architecture) and benefits strategy/administration Experience preparing and presenting to Compensation Committees; strong grasp of governance, disclosure, and regulatory considerations Experience with benefits administration, program design, vendor management, and employee communication related to health, welfare, and retirement plans Working familiarity with ADP Workforce Now (or a similar HRIS/Payroll system) is preferred, with the ability to oversee system functionality, vendor partnerships, and process efficiency People analytics fluency: metrics design, dashboarding, data governance, and storytelling to influence senior leaders &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

VP, Total Rewards, People Operations & Analytics

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The&nbsp;Associate&nbsp;Director,&nbsp;Managed Markets&nbsp;will&nbsp;bring their extensive&nbsp;Market Access&nbsp;marketing&nbsp;experience to our first product launches in neuromuscular disease&nbsp;with&nbsp;an&nbsp;initial&nbsp;focus on launch readiness and commercialization of our lead assets in Duchenne Muscular Dystrophy&nbsp;(DMD)&nbsp;and myotonic dystrophy Type I (DM1).&nbsp;The&nbsp;Associate&nbsp;Director&nbsp;is&nbsp;responsible for&nbsp;developing and implementing&nbsp;Access&nbsp;Marketing&nbsp;strategies and&nbsp;tactics across Payer Marketing and Patient Support Services.&nbsp;They will collaborate with Legal,&nbsp;Compliance,&nbsp;Marketing, Sales, Market Access, Patient Services, Commercial Operations, and&nbsp;others&nbsp;as necessary. This position is critical to ensuring&nbsp;Dyne&nbsp;has&nbsp;the most efficient and seamless way possible of reaching our&nbsp;HCPs,&nbsp;patients, payers, and other key stakeholders&nbsp;living with&nbsp;these&nbsp;severe diseases.&nbsp;A successful candidate is a self-starter who is highly driven, collaborative, and embodies values such as bold thinking,&nbsp;agility,&nbsp;and&nbsp;an&nbsp;execution-focus.&nbsp; This is a unique opportunity for an exceptional strategic thinker and commercial leader to play a key role&nbsp;in bringing critical therapies to the patients who need them.&nbsp; This role is based in Waltham, MA.&nbsp; Primary Responsibilities: &nbsp; Support development of&nbsp;Payer Value Propositions&nbsp;and associated resources.&nbsp;Craft compelling, evidence-based value propositions tailored to payers (commercial, Medicare, Medicaid).&nbsp;&nbsp;Align messaging with product clinical, economic, and humanistic value.&nbsp; Create Access Marketing Tools &amp; Resources.&nbsp;&nbsp;Develop payer-facing materials such as AMCP dossiers, value decks, budget impact models, and objection handlers.&nbsp;Ensure materials are compliant with regulatory and legal standards.&nbsp; Market Access Strategy Development.&nbsp;Collaborate with cross-functional teams (e.g., HEOR, Pricing, Medical Affairs, Sales) to build&nbsp;payer&nbsp;strategy across product&nbsp;lifecycle.&nbsp; Support Pricing &amp; Contracting Strategy.&nbsp;&nbsp;Provide marketing input to guide contract pull-through strategies.&nbsp; Payer &amp; Stakeholder Engagement.&nbsp;&nbsp;Support Account Directors and Field Access teams with payer engagement initiatives.&nbsp; Develop customized tools and communication strategies&nbsp;for key stakeholders (e.g., payers, IDNs, ACOs).&nbsp;&nbsp; Partner&nbsp;with Patient Support, Marketing, Commercial Analytics and Sales to continually&nbsp;monitor, assess and evolve the distribution strategy and tactics to ensure&nbsp;objectives&nbsp;are met and exceeded.&nbsp; Develop HCP and patient-facing resources&nbsp;in support of Patient Support Services and Distribution, inclusive of services across Hub, Financial Assistance, and accessing&nbsp;product.&nbsp; Training &amp; Enablement.&nbsp;&nbsp;Train Market Access and Sales teams on payer messaging, tools, and tactics.&nbsp;&nbsp;Create and&nbsp;maintain&nbsp;access&nbsp;marketing&nbsp;training content.&nbsp; &nbsp; Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; BA/BS degree&nbsp;required; advanced&nbsp;degree (MBA, PhD, PharmD) preferred&nbsp; 10+ years of bio/pharmaceutical experience required with a key understanding of current US pharmaceutical payer, patient support, and distribution processes.&nbsp; Previous&nbsp;rare disease experience and Buy-and-Bill models, including infusion products, preferred.&nbsp; Demonstrated&nbsp;access marketing&nbsp;experience in process development for coordination with&nbsp;Payers,&nbsp;HUB, co-pay,&nbsp;distribution,&nbsp;and other patient service providers&nbsp; Influential personality with the ability to simplify and clarify complex issues to broad and diverse audiences&nbsp; Enterprise mindset that makes culture and values come to life in everyday activities&nbsp; Experience in a small, rapidly growing biotech with the ability to&nbsp;operate&nbsp;and maneuver in a start-up environment while keeping a solutions-oriented mentality&nbsp;&nbsp; Demonstrates an authentic willingness and capability to roll up sleeves rather than relying on others for delivery&nbsp; Ability to travel to meet business&nbsp;objectives.&nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, Managed Markets

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; We are seeking a Director, Global HEOR, to lead the strategy and execution of how we define, substantiate, and communicate the value of one or more medicines approaching commercialization. This role is responsible for ensuring that, from clinical development through real-world evidence generation and payer engagement, we are making the strongest and best-supported arguments to secure access to our medicines. Accordingly, the Director, Global HEOR, helps shape development plans, evidence strategies, and value narratives so that they align with how payers and health technology assessment (HTA) bodies make decisions, balancing analytical rigor with a clear focus on what is relevant for decision-making. This is a highly cross-functional, hands-on role for someone who combines deep analytical thinking with sound judgment, intellectual curiosity with pragmatism, and a strong orientation toward results. The role directly influences how our medicines are developed, positioned, and ultimately accessed by patients worldwide. Success in this role requires continually asking not just “Is this analysis methodologically defensible?” but “Does this help us make a better case for access, and if not, what would?” This role is based in Waltham, MA. Primary Responsibilities Include: Informing development strategies from HEOR / market access perspective Represent the HEOR and market access perspective in internal clinical development and regulatory forums Provide critical input into clinical development plans, including protocol design, endpoint selection, and other aspects of clinical trial evidence generation, to ensure alignment with future payer and HTA expectations Communication of value to payers and HTA bodies Lead development of AMCP dossiers for US payers Lead development of cost-effectiveness models for NICE and other HTA bodies requiring formal cost-effectiveness analyses Serve as a core team member for HTA submissions outside the US, with responsibility for shaping and stress-testing value narratives included in pricing and reimbursement dossiers and interpreting and recommending evidence to support such narratives, in a way that optimizes both credibility and relevance for payer decision-making Make substantial contributions to other payer communication materials (e.g., Medical Value Liaison slide decks) and launch readiness activities as needed Leading real-world evidence strategy and execution of real-world analyses Lead planning of real-world evidence generation activities to address evidence gaps as needed for informing decision-making by payers, HTA bodies, and clinicians Oversee execution of real-world data analyses, ensuring analytical rigor and fitness for purpose Interpret and translate results from real-world analyses into peer-reviewed publications and other external communications intended to meaningfully inform clinical practice and payer/HTA decision-making Education and Skills Requirements: Bachelor’s degree or equivalent experience in a relevant field such as economics, public health, epidemiology, biostatistics, health policy, life sciences, or a related discipline. Advanced degrees (Master’s, PhD, PharmD, MD) are welcome but not required. 10+ years of progressive experience in HEOR, health analytics, value demonstration, market access, or a closely related quantitative or scientific field. Demonstrated success leading complex evidence‑generation, modeling, or analytical programs within biopharma, healthcare consulting, payer organizations, or academic research environments. Experience influencing senior leaders and driving strategic decisions through evidence and structured analysis. We are looking for candidates who demonstrate the following skills and qualities: Analytical ability: Strong reasoning and structured problem‑solving capabilities, with curiosity, persistence, and creativity to tackle complex, open‑ended problems. Sophisticated understanding of evidence: Clear judgment about what different analytical methodologies can and cannot tell you, and what makes an analysis more or less robust. Understanding of value frameworks: Familiarity with decision‑making frameworks that inform how medicines are valued, priced, and reimbursed. Strong mathematical intuition: Deep understanding of how numbers work, how models behave, and how assumptions propagate through analyses. Critical evaluation of scientific literature: Ability to read, interpret, and rigorously critique medical, scientific, and health economics publications. Biological and clinical literacy: Sufficient grounding in biology and clinical science to engage effectively with development teams and external clinical experts. Results orientation: Focus on organizational priorities—balancing rigor with pragmatism and avoiding analysis for analysis’ sake. Bias toward solutions and progress: Mindset oriented toward finding solutions, offering alternatives, and maintaining momentum. &nbsp;MA Pay Range$210,000&mdash;$252,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Global Health Economics & Outcomes Research (HEOR)

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: Dyne seeks an experienced Data Integration Engineer to lead, manage, and&nbsp;optimize&nbsp;data integration across our organization and with external partners. The ideal candidate has deep&nbsp;expertise&nbsp;in integration architecture, hands-on experience with the stand-up and operation of Boomi and Snowflake, and a strong background in biotech or pharmaceutical environments where compliance and data integrity are paramount.&nbsp; This role is based in Waltham, MA. &nbsp; &nbsp;Primary Responsibilities Include: &nbsp; Integration Ownership &amp; Development:&nbsp; Serve as the primary owner of the Boomi integration platform and Snowflake data lake environment. &nbsp; Design, build, and deploy integrations between internal systems and external partners (e.g., 3PL, specialty pharmacy, CROs, data aggregators). &nbsp; Develop and&nbsp;maintain&nbsp;integration&nbsp;workflows, connectors, APIs, and ETL/ELT processes for data ingestion and transformation. &nbsp; Ensure integrations are secure, scalable, and compliant with industry standards and regulatory requirements (e.g.,&nbsp;GxP). &nbsp; Support the onboarding of the company’s data aggregator &nbsp; Platform Management:&nbsp; Configure,&nbsp;optimize, and&nbsp;maintain&nbsp;Boomi and Snowflake environments. &nbsp; Manage user access, roles, and permissions for integration and data platforms. &nbsp; Implement best practices for security, performance, and scalability. &nbsp; Monitor integration and system performance, troubleshoot issues, and implement error handling, logging, and alerting. &nbsp; Data Modeling &amp; Analytics Enablement:&nbsp; Design and build robust data models and schemas to support business functions (Commercial, Clinical, R\&amp;D). &nbsp; Layer on visualization tools (Power BI, Tableau) for reporting and dashboards. &nbsp; Support BI and dashboarding initiatives and provide guidance on data access.&nbsp; &nbsp; Collaboration &amp; Documentation:&nbsp; Work closely with IT, Commercial, Clinical, Finance, and other areas of the business as well as external vendors to understand integration requirements. &nbsp; Document&nbsp;integration&nbsp;architecture, processes, and best practices. &nbsp; Provide ongoing support, enhancements, and documentation for existing integrations and platforms.&nbsp; &nbsp; Education and Skills Requirements: &nbsp; Bachelors in&nbsp;Computer&nbsp;Science&nbsp;required,&nbsp;Master’s&nbsp;degree preferred&nbsp; 5+ years of experience in integration engineering, data engineering, or related roles&nbsp; Hands-on experience with Boomi (design, deployment, administration) and Snowflake (configuration, optimization, data modeling)&nbsp; Strong understanding of APIs, web services (REST/SOAP), data formats (JSON, XML), and SQL&nbsp; Experience integrating ERP, CRM, HRIS, and other data platforms&nbsp; Proficiency&nbsp;with Power BI and Tableau for data visualization&nbsp; Experience in biotech or pharmaceutical environments, including integrations with 3PLs, specialty pharmacies, CROs, and clinical systems&nbsp; Understanding of compliance requirements (e.g.,&nbsp;GxP, HIPAA) and data governance in life sciences&nbsp; Ability to work independently and manage multiple priorities in a fast-paced environment&nbsp; Strong communication&nbsp;and collaboration skills across technical and business teams&nbsp; Familiarity with NetSuite, Veeva, ADP, and Snowflake integrations&nbsp; Knowledge of cloud platforms such as AWS and security best practices&nbsp; Experience with clinical trial data, commercial sales data, and regulatory reporting&nbsp; Snowflake&nbsp;SnowPro&nbsp;certification preferred&nbsp; Boomi Developer certification preferred&nbsp; &nbsp; #LI-OnsiteMA Pay Range$143,000&mdash;$175,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Data Integration Engineer

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director, Medical&nbsp;Information&nbsp;is responsible for&nbsp;establishing&nbsp;and leading the medical information function to ensure&nbsp;timely,&nbsp;accurate, balanced, and compliant scientific responses to unsolicited inquiries from healthcare professionals. This role plays a critical part in supporting the safe and&nbsp;appropriate use&nbsp;of the company’s products by delivering high-quality medical information and enabling scientific exchange. The&nbsp;person in this role&nbsp;has strong scientific&nbsp;expertise, experience in regulated environments, and the ability to build scalable medical information processes in a biotech setting.&nbsp; This role is based in Waltham, MA without the possibility of being remote.&nbsp;&nbsp;Primary Responsibilities&nbsp;Include: &nbsp; Establish and lead the medical information function, including strategy, processes, and execution.&nbsp; Establish scalable medical information infrastructure, including inquiry intake, documentation, and response workflows.&nbsp; Oversee&nbsp;the implementation&nbsp;and training&nbsp;of&nbsp;the medical inquiry intake portal and call center vendors and manage&nbsp;relationships&nbsp;going forward.&nbsp; Develop high-quality medical information response documents (standard response letters, FAQs,&nbsp;backgrounders)&nbsp;and&nbsp;maintain&nbsp;medical information content aligned with product labeling, clinical data, and evolving scientific evidence.&nbsp; Ensure responses are scientifically&nbsp;accurate, balanced, up-to-date, and compliant with regulations.&nbsp; Ensure&nbsp;appropriate escalation&nbsp;and coordination of safety, quality, and off-label inquiries.&nbsp; Analyze inquiry trends to&nbsp;identify&nbsp;knowledge gaps, unmet medical needs, and opportunities to inform medical strategy.&nbsp; Monitor metrics and quality indicators to ensure continuous improvement and compliance.&nbsp; &nbsp; Education and Skills Requirements:&nbsp; Doctorate degree (MD, PhD, PharmD) with&nbsp;10+&nbsp;years of experience&nbsp;in&nbsp;medical information or medical affairs in rare diseases, neuromuscular diseases, or a related field&nbsp; Experience&nbsp;establishing&nbsp;or leading a medical information function is strongly preferred&nbsp; Strong understanding of regulatory, compliance, and pharmacovigilance requirements&nbsp; Excellent scientific writing and verbal communication skills&nbsp; Strong organizational and process-building capabilities&nbsp; High attention to detail and commitment to compliance and scientific integrity&nbsp; Ability to work effectively in a matrixed, fast-paced biotech environment&nbsp; Strong judgment in handling complex or sensitive inquiries&nbsp; MA Pay Range$183,000&mdash;$255,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Medical Information

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The&nbsp;Executive Director, Business &amp; Digital Platforms Lead&nbsp;at Dyne&nbsp;is a strategic leader and trusted advisor who will help architect&nbsp;Dyne’s business systems and associated processes across R&amp;D, G&amp;A,&nbsp;and&nbsp;Technical Operations&nbsp;with a strong focus on Commercial and Medical.&nbsp;This role is&nbsp;beyond&nbsp;systems&nbsp;-&nbsp;it’s&nbsp;about&nbsp;leading and&nbsp;shaping how Dyne connects with patients and providers, how we deliver therapies efficiently, and how we scale for future launches.&nbsp;This individual&nbsp;will work in lockstep with our Business Operations teams, Commercial and Medical,&nbsp;and&nbsp;cross-functional partners&nbsp;across all business areas.&nbsp;&nbsp;This individual will define and execute a roadmap that integrates&nbsp;cutting-edge&nbsp;platforms, data-driven insights, and compliant processes to support Dyne’s commercialization strategy in the US and globally.&nbsp; This role is based&nbsp;in Waltham, MA. Primary Responsibilities Include: &nbsp; Serve as the primary technology leader and business partner&nbsp;across the business with a focus on&nbsp;Commercial&nbsp;and Medical&nbsp;functions, building strong relationships with&nbsp;senior&nbsp;leadership and stakeholders to understand business&nbsp;objectives, priorities, and technology&nbsp;and&nbsp;process&nbsp;needs&nbsp;and gaps.&nbsp; Collaborate with Medical Affairs, Commercial Operations, Marketing, Market Access,&nbsp;Patient Services&nbsp;as well as G&amp;A, R&amp;D and other business functions&nbsp;to design&nbsp;and implement&nbsp;a technology roadmap that supports Dyne’s launch strategy and long-term growth.&nbsp; Lead the delivery, support, and continuous improvement of&nbsp;business&nbsp;technology platforms (e.g., CRM, data management, omnichannel engagement, analytics), ensuring they are robust&nbsp;and scalable.&nbsp; Align IT initiatives with business priorities, ensuring scalability for multiple product launches and global expansion.&nbsp; Serve as the primary IT liaison for&nbsp;medical and&nbsp;commercial teams, translating business needs into actionable technology solutions.&nbsp; Lead&nbsp;and manage&nbsp;future IT&nbsp;Business&nbsp;Partners to&nbsp;support business areas as Dyne grows.&nbsp;&nbsp; Foster strong relationships with internal stakeholders and external vendors to deliver best-in-class platforms.&nbsp; Enable Dyne’s Omnichannel Engagement model incorporating field learning, digital, and data insights.&nbsp; Lead initiatives to implement and&nbsp;optimize&nbsp;CRM systems (e.g., Veeva Vault CRM and Patient services CRM), digital engagement tools, and analytics platforms that empower field teams and enhance customer experience.&nbsp; Lead with Compliance and Trust—embedding regulatory compliance (e.g.,&nbsp;GxP, GDPR) into every solution, safeguarding our data and&nbsp;maintaining&nbsp;Dyne’s reputation for integrity.&nbsp; Oversee the lifecycle of commercial technology solutions, including&nbsp;requirements&nbsp;gathering, vendor management, implementation, and ongoing support.&nbsp; Be a champion of innovation--Identifying&nbsp;emerging technologies that can elevate Dyne’s commercial&nbsp;and medical&nbsp;capabilities and patient engagement strategies.&nbsp; Bring forward ideas that challenge the status quo and deliver measurable business impact.&nbsp; Education and Skills Requirements: &nbsp; Bachelor's&nbsp;degree&nbsp;required, preferably in Computer Science or Business Administration, MBA preferred&nbsp; 18+ years&nbsp;of&nbsp;experience&nbsp;as an&nbsp;IT&nbsp;leader&nbsp;in&nbsp;roles supporting commercial and medical functions, R&amp;D and&nbsp;G&amp;A functions&nbsp;in biotech&nbsp;or pharmaceutical industry&nbsp; 10+&nbsp;years overseeing cross functional implementations,&nbsp;running task plans (Smartsheet preferred), setting&nbsp;goals&nbsp;and aligning dates with business&nbsp;needs.&nbsp; AI Fluency Preferred—deploying workforce automation or using LLM enhanced processes as workforce multipliers.&nbsp; Experience “building from scratch” an&nbsp;IT business partner team,&nbsp;commercial ecosystem&nbsp;required&nbsp;for launch of a rare disease product.&nbsp; Deep understanding of&nbsp;requirements and methods to build and&nbsp;operate&nbsp;CRM platforms&nbsp;(preferably Veeva),&nbsp;patient services,&nbsp;omnichannel&nbsp;marketing,&nbsp;business&nbsp;analytics, and&nbsp;other&nbsp;digital engagement technologies.&nbsp; Strong business acumen with the ability to influence senior stakeholders, motivate and lead project&nbsp;teams, and&nbsp;shape strategy.&nbsp; Expertise&nbsp;working collaboratively--ensuring&nbsp;the right people are “at the table” when making key&nbsp;business and technology&nbsp;strategy decisions.&nbsp; A passion for Dyne’s mission and a commitment to building systems that make a difference for patients.&nbsp;&nbsp; Ability to articulate a commercial business&nbsp;technology ecosystem at all levels of our business&nbsp; &nbsp; &nbsp; #LI-OnsiteMA Pay Range$241,000&mdash;$295,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Executive Director, Business & Digital Platforms Lead

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.&nbsp; This role is based in Waltham, MA without the possibility of being a remote role. &nbsp; Primary Responsibilities Include: Inform and contribute to audit planning and strategy&nbsp; Perform and/or coordinate clinical site and vendor audits&nbsp; Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs&nbsp; Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends&nbsp; Support inspection readiness activities and co-host regulatory inspections&nbsp; Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements&nbsp; Conduct and/or manage the qualification and oversight of service providers&nbsp; Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness&nbsp; Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity&nbsp; Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings&nbsp; Support investigational new drug (IND) applications and related correspondence with global regulatory authorities Education and Skills Requirements: Bachelor’s degree in a scientific, allied health, or medical field required; Master’s degree preferred&nbsp; Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience)&nbsp; Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements&nbsp; Broad clinical development experience across all phases (Phase I through BLA/NDA)&nbsp; Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages&nbsp; Proven experience developing and implementing risk-based clinical quality assurance programs&nbsp; Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings&nbsp; Skilled at effectively communicating quality events and outcomes to internal stakeholders&nbsp; Excellent interpersonal, verbal, and written communication skills&nbsp; Working knowledge of multiple therapeutic areas is a plus&nbsp; Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines&nbsp; Flexible and creative problem solver with a proactive mindset&nbsp; Highly collaborative team player who fosters open communication and cross-functional cooperation&nbsp; Willingness to travel up to 20% based on business needs&nbsp; &nbsp; #LI-OnsiteMA Pay Range$190,000&mdash;$232,800 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Clinical Quality Assurance

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The&nbsp;Associate Director,&nbsp;US Marketing Operations&nbsp;establishes&nbsp;and leads the tactical execution of marketing operations, with an immediate focus on launch readiness for Dyne’s lead assets in Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1). As Dyne transitions into a fully integrated biotechnology company, this role plays a critical part in building the systems, processes, and operational infrastructure&nbsp;required&nbsp;to enable compliant, impactful, and efficient delivery of therapeutic education to US external stakeholders.&nbsp; The Associate Director serves as a key partner across Marketing, Commercial Operations, Medical Affairs, Market Access, Patient Services, Regulatory, Legal, Compliance, and Information Technology, driving operational excellence and enabling speed to market in highly regulated and complex therapeutic landscapes. This role is located in our Waltham, MA office. Primary Responsibilities&nbsp; Commercial MLR Review Committee Leadership&nbsp; Chair the Dyne Commercial Medical, Legal, and Regulatory review committee and manage the end-to-end content review and approval process for Commercial-led therapeutic education&nbsp; Partner closely with Marketing, Medical, Legal, and Regulatory teams to foster a collaborative, solution-oriented review culture&nbsp; Ensure&nbsp;timely, compliant review of HCP, payer, and patient-facing materials and&nbsp;optimize&nbsp;systems supporting content workflows such as Veeva Vault&nbsp;PromoMats&nbsp; Collaborate with Regulatory, Legal, and Compliance to&nbsp;maintain&nbsp;policies, procedures, and governance aligned with evolving regulatory standards&nbsp; HCP and Consumer Engagement&nbsp; Design and implement a fit-for-purpose HCP and consumer peer-to-peer engagement model that meets the unique educational needs of rare disease launches in DMD and DM1&nbsp; Oversee HCP and consumer engagement operations across the Commercial organization, including nomination, contracting, onboarding, training,&nbsp;logistics, and relationship management&nbsp; Ensure compliance with all applicable industry regulations and internal policies, including&nbsp;fair market value&nbsp;requirements and Sunshine reporting&nbsp; Marketing Excellence and Performance&nbsp; Serve as a strategic partner to Dyne Brand Teams, aligning Marketing Operations capabilities to commercial&nbsp;objectives&nbsp;to enhance executional effectiveness&nbsp; Drive continuous improvement across marketing operations processes to support agility, scalability, and compliance&nbsp; Oversee print fulfillment operations and manage promotional asset lifecycle planning&nbsp; Partner with Commercial Operations, Information Technology, and Analytics teams to enable systems that track performance and integrate insights into campaign design and optimization&nbsp; Ensure personalized and precise customer engagement through effective use of data, segmentation, and targeting strategies&nbsp; Congress and Meeting Management&nbsp; Lead planning and execution of US HCP and consumer-facing congresses, conventions, and field-sponsored events to maximize Dyne’s presence and engagement impact&nbsp; Partner closely with Marketing, field-facing teams, and Medical Affairs to coordinate KOL engagement strategies at congresses, ensuring operational excellence, brand alignment, and compliance&nbsp; Qualifications&nbsp; Bachelor’s degree&nbsp;required; advanced degree such as MBA or MPH preferred&nbsp; 8+ years of experience in the pharmaceutical or biotechnology industry, with experience supporting rare disease or accelerated approval launches preferred&nbsp; Demonstrated ability to thrive in fast-paced environments with strong prioritization and problem-solving skills&nbsp; Proactive, adaptable, and solution oriented, with&nbsp;a track record&nbsp;of delivering results under tight timelines&nbsp; Proven experience leading promotional review processes in regulated environments&nbsp; Deep understanding of US regulatory requirements and compliance standards governing promotional activity&nbsp; Excellent communication, interpersonal, and stakeholder management skills&nbsp; Strong business acumen with the ability to translate strategic&nbsp;objectives&nbsp;into operating execution&nbsp; Experience with commercial systems and platforms such as Veeva Vault&nbsp;PromoMats&nbsp;highly preferred&nbsp; Experience&nbsp;operating&nbsp;effectively in a small, rapidly growing biotech environment with comfort navigating ambiguity&nbsp; &nbsp;MA Pay Range$155,000&mdash;$190,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, US Marketing Operations

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: In this role, the Franchise Counsel will serve as the lead counsel for clinical therapies and pharmaceutical brands.&nbsp; The Franchise Counsel will provide legal guidance on a wide range of commercialization issues as Dyne scales and prepares for the anticipated launch of its first therapies.&nbsp; These topics include advertising and promotion, compliance with FDA regulations, health care fraud and abuse laws, Value &amp; Access matters, patient support programs, data privacy, and various federal and state laws governing the pharmaceutical industry. The Franchise Counsel will work closely with Medical, Commercial, Regulatory Affairs and G&amp;A colleagues.&nbsp; This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area. Primary Responsibilities: Commercialization &amp; Launch Readiness Serve as lead counsel for Dyne’s therapeutic franchises, advising on commercial and medical strategies from development through launch. Provide legal review and counsel for promotional and non-promotional materials, including sales and marketing collateral, scientific exchange, digital media, and disease-state education. Advise on pricing, value &amp; access strategies, contracting, trade and distribution matters, and patient access programs to ensure compliance with FDA, OIG, and industry standards. Support launch, inspection, and filing readiness activities across cross-functional teams. Compliance &amp; Risk Management Advise on FDA regulations, federal and state fraud and abuse laws, and obligations under U.S. federal health care programs. Support the development, implementation, and monitoring of Dyne’s compliance program. Review and approve grants, sponsorships, and medical education programs in alignment with company policy and industry codes. Oversee transparency reporting, data privacy (including GDPR and U.S. state laws), and other global health care compliance obligations. Partner with Legal and Compliance colleagues to provide training and proactive risk assessments. Business Partnership &amp; Leadership Act as the primary legal business partner to key functions including Commercial, Medical Affairs, Regulatory, and G&amp;A. Represent Legal on cross-functional project and governance teams to support launch readiness and commercial objectives. Collaborate with internal stakeholders and external partners to ensure compliant and effective business operations. Help mature Dyne’s health care law capabilities and identify opportunities for process improvement and proactive legal risk management. Support the Head of Legal in health care, compliance, and operational matters. Education, Knowledge &amp; Skill Requirements: JD from an accredited law school; licensed to practice in at least one U.S. jurisdiction. 10+ years of health care law and compliance experience, ideally within a global biotechnology company and a top-tier law firm. Deep expertise in FDA regulations, U.S. health care laws, and federal health care programs; familiarity with ex-U.S. frameworks (e.g., EFPIA, GDPR). Strong understanding of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy, and transparency laws. Demonstrated content review committee experience in the pharmaceutical industry. Proven success advising cross-functional teams (Medical, Commercial, Regulatory, Technical Operations, and G&amp;A) on complex, time-sensitive matters. Skilled at balancing strategic legal guidance with practical business judgment in fast-paced, evolving environments. Exceptional communication, analytical, and project management skills with attention to detail and execution excellence. Collaborative leadership style and enterprise mindset that reinforces organizational culture and values. Experience thriving in a small, rapidly growing biotech or start-up environment with a solutions-oriented approach. &nbsp; &nbsp; #LI-OnsiteThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Franchise Counsel

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Associate Director, Commercial Insights and Analytics is responsible for driving the development and execution of market insights to support commercial preparation for Dyne’s first product launches in rare neuromuscular diseases. Key areas of focus include data analytics and reporting, forecasting, market research, and competitive intelligence. This individual, who reports directly into the Senior Director, Insights and Analytics, also works closely with many other functions, including but not limited to, marketing, market access, and program teams to support insights generation that will drive brand strategy and execution. This role is based in Waltham, MA. Primary Responsibilities Include: Commercial Data Analytics and Reporting Build and maintain reporting systems using tools like Tableau, Power BI, etc. Partner with IT/Data teams to ensure data integrity and integration across platforms (CRM, claims, EMR, etc.) Standardize reporting templates for executive, field, and cross-functional use Support implementation of KPIs and performance dashboards across functions Educate internal stakeholders on data literacy and dashboard usage Stay current on industry trends and emerging tools to continuously elevate analytics capabilities Ensure compliance with data governance and privacy standards Manage vendor relationships for data acquisition and analytics platforms Forecasting Develop forecasting models and scenario planning tools for product uptake, access, and revenue using best-in-class forecast modeling approaches. Actively evaluate current forecasting processes/methodologies for opportunities to enhance capabilities, with a focus on accuracy and agility Triangulate and pressure-test assumptions with various data sources (primary research, competitive intelligence, analogs, etc.) and clearly communicate assumptions to key stakeholders Support long-range planning and scenario modeling activities for internal assets (including lifecycle management) Leverage strong analytical capabilities and experience to create clear actionable insights and provide strategic recommendations Serve as a strategic business partner for commercial leads and cultivate strong relationships with key stakeholders and peers across Brand Teams, Market Access, Finance, Supply, Trade, and IT Market Intelligence&nbsp; Collaborate with commercial leads to develop, refine, and implement insights generation plans for decision support Lead competitive analysis to assess market dynamics, product positioning and to monitor emerging threats. Manage projects and relationships with market research and intelligence vendors, ensuring alignment with business needs and quality standards Present key insights and recommendations to senior leadership with clarity and strategic context Education and Skills Requirements: Bachelor’s degree required; advanced degree (MBA, PhD, PharmD) preferred&nbsp; 8+ years of experience in analytics, reporting, or commercial insights in biotech/pharma (either in-house or at vendor). Experience supporting new product launches and/or rare diseases preferred. Familiarity with regulatory requirements and industry standards related to market research and data analytics in the pharma/biotech sector Strong proficiency in analytical tools, models, software and data visualization platforms used to work with large and complex datasets(e.g., Tableau, Power BI) Exceptional communication and presentation skills with a track record of effectively conveying insights to diverse audiences of internal and external stakeholders Strong data storytelling skills with ability to distill complex information into concise and impactful visuals, messages, and presentations Ability to operate in a fast-paced, dynamic environment, managing multiple tasks and priorities simultaneously Knowledge of AI tools and digital technologies Comfortable manging and negotiating with external vendors Upholds the highest standards of professionalism, ethics, and integrity &nbsp;MA Pay Range$155,000&mdash;$190,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, Commercial Insights and Analytics

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The Director, Strategy &amp; Business Operations is a strategic and operational partner to Dyne’s leadership, playing a central role in enabling effective Executive Committee (EC) and Board decision-making. This leader drives the end-to-end process for EC and Board submissions; synthesizes complex, cross-functional insights into decision-ready narratives; and leads high-priority, cross-enterprise initiatives tied to corporate strategy and operational excellence. The ideal candidate is proactive, highly organized, analytically strong, and thrives in a fast-paced, highly visible environment. They combine executive presence with rigorous analysis, clear storytelling, and an ability to orchestrate alignment and execution across R&amp;D, Manufacturing, Commercial, Finance, and G&amp;A teams. This role is based in Waltham, MA without the possibility of being a remote role. Primary Responsibilities Executive &amp; Board Support Partner closely with executive leadership to plan, coordinate, and manage EC and Board agendas and operating rhythms Lead the development and refinement of EC/Board materials (presentations, dashboards, briefing documents, pre-reads) that are clear, concise, and decision-oriented Ensure leadership materials consistently highlight tradeoffs, risks, scenarios, dependencies, and recommendations Collaborate with HR and other stakeholders on leadership meeting design, cadence, and execution Prepare high-quality briefing materials, presentations, and reports for the CEO and executive team Analytics, Insights &amp; Enterprise Performance Synthesize complex, cross-functional data into executive-level insights, visualizations, and storylines that enable strategic choices and accountability Develop integrated views of performance, progress, risks, and dependencies using data from multiple functions; ensure consistency, accuracy, and relevance Elevate the use of analytics in EC/Board discussions by framing metrics in context (benchmarks, trends, thresholds) and proposing clear actions Strategic Initiatives &amp; Cross-Functional Leadership Lead enterprise-wide, high-priority initiatives that advance corporate strategy and operational priorities Establish project plans, milestones, owners, and success metrics; drive execution and accountability across teams Use data and insights to track progress, identify risks, and recommend course corrections; escalate issues with solutions Lead special initiatives requiring senior leadership engagement and cross-functional coordination Process Excellence &amp; Operating Rhythm Optimization Own and continuously improve the end-to-end process for EC and Board submissions (timelines, templates, standards, content expectations) Drive consistency and quality across leadership materials, including analytical rigor, visual clarity, and narrative coherence Identify and implement opportunities to streamline decision processes, operating rhythms, and cross-functional workflows to enhance organizational effectiveness Stakeholder Engagement &amp; Executive Communications Serve as a trusted liaison between executive leadership and functional teams to ensure alignment, transparency, and timely decision-making Foster strong relationships with internal stakeholders and Board members Draft and refine executive-level presentations and correspondence; support leaders with data-backed storytelling for leadership forums and internal communications Qualifications Bachelor’s degree required; advanced degree (MBA, MS) preferred or equivalent practical experience 10+ years of relevant experience in Strategy &amp; Operations, Corporate Strategy, Management Consulting, PMO/Transformation, or related roles; experience supporting executive/Board governance strongly preferred Demonstrated ability to translate complex, cross-functional data into executive-ready insights, scenarios, and recommendations; strong quantitative and qualitative problem-solving skills Exceptional written and verbal communication skills with a track record of producing concise, compelling leadership materials Proven ability to lead enterprise initiatives, influence without authority, and drive accountability across diverse teams Experience designing and improving operating rhythms, governance processes, and submission standards Advanced proficiency with Microsoft PowerPoint and Excel. Familiarity with dashboarding/visualization tools (e.g., Power BI, Tableau) is a plus MA Pay Range$196,000&mdash;$240,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Business Strategy & Operations

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Contracts Manager is responsible for managing a wide range of contract negotiations and agreements to support Dyne Therapeutics' business operations and collaborations. This role focuses on drafting and negotiating service agreements, clinical trial agreements, consulting agreements, pharmacy benefit manager agreements, license agreements, confidential disclosure agreements. Additionally, the Contracts Manager handles other commercial phase agreements and mitigates risk.&nbsp;The person in this role will be able to manage multiple priorities and work collaboratively in an environment with multiple stakeholders.This role is based in Waltham, MA without the possibility of being a remote role. Primary Responsibilities Include: Drafts, reviews, and negotiates a wide range of contracts Ensure contracts align with company policies, legal standards, and business objectives Assist with the maintenance of a centralized contract repository; ensuring all contracts are properly filed, tracked, and accessible; monitoring contract deadlines and renewals; and assisting with the contracts execution process Identify and mitigate potential risks in contract terms and conditions in partnership with Contracts leadership Work closely with internal departments (e.g., Sales, Finance, IT, Clinical Operations, Commercial, and Medical Affairs) to understand their contract needs and provide support Assist in developing and updating contract templates, policies, and procedures to improve efficiency and reduce risk Assist in training and educating employees on contract-related processes and best practices As needed, prepare reports on contract status and key metric &nbsp; Education and Skills Requirements: Bachelor’s degree in Law, Business Administration, or a related field preferred Paralegal certification or equivalent experience may be considered. Minimum of 5 years of experience in contract management, preferably in the biotechnology or pharmaceutical setting Experience with Conga Contracts preferred Proven experience drafting, reviewing, and negotiating complex contracts Strong understanding of contract law and legal terminology Excellent negotiation, communication, and interpersonal skills High attention to detail and organizational skills Proficiency in contract management software and Microsoft Office Suite. Ability to work with minimal supervision and manage multiple priorities in a fast-paced environment Certified Commercial Contracts Manager (CCCM) or equivalent certification is strongly preferred. &nbsp; &nbsp; #LI-OnsiteMA Pay Range$118,340&mdash;$145,500 USDThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Contracts Manager

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Executive Director, Head of Bioanalytical Development will lead the bioanalytical capabilities and work on our programs to develop, validate and implement robust PK and immunogenicity assays that allows accelerated transition from the bench to the clinic, from discovery through IND, late-stage clinical development and licensure. This role will help lead and build internal capability for ligand binding, mass spectrometry and molecular assay development of PK and ADA for Dyne Therapeutics’ portfolio. In addition, this role will lead the selection of strategic partner labs for the use of these assays in toxicology studies and clinical trials in keeping with all applicable regulatory expectations. This position will report to the head of Translational Biomarkers at Dyne Therapeutics. The role will work collaboratively across multiple research and clinical teams for the development, technology transfer and oversight of vendors running those bioanalytical assays to support preclinical studies and clinical trials conducted by Dyne Therapeutics.&nbsp; This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area &nbsp; Primary Responsibilities Include:&nbsp; Lead and evolve the Bioanalytical Development function, overseeing assay development, validation, and implementation for PK and immunogenicity endpoints.&nbsp;&nbsp; Develop and execute strategic plans aligned with pipeline priorities, ensuring timely and high-quality data delivery.&nbsp;&nbsp; Build and mentor a high-performing team with diverse technical expertise and an innovative mindset.&nbsp;&nbsp; Serve as the primary scientific interface with CROs and external partners, ensuring alignment on quality, timelines, and regulatory compliance.&nbsp;&nbsp; Collaborate cross-functionally with Clinical Pharmacology, Preclinical Development, Regulatory Affairs, Quality Assurance, and Therapeutic Area leads to support integrated development strategies.&nbsp;&nbsp; Ensure compliance with global regulatory standards (FDA, EMA, ICH, GCP, GLP) and contribute to regulatory filings (IND, BLA, MAA).&nbsp;&nbsp; Champion the adoption of cutting-edge technologies and methodologies in bioanalysis, including ligand-binding assays, LC-MS/MS, and cell-based assays.&nbsp;&nbsp; Drive continuous improvement initiatives and implement best practices in bioanalytical operations and data integrity.&nbsp; Education and Skills Requirements:&nbsp; Ph.D. or equivalent in Biochemistry, Pharmacology, or related field with 10-12+ years of experience in bioanalytical sciences within the biopharmaceutical industry.&nbsp;&nbsp; Proven leadership experience managing large, multidisciplinary teams and external partnerships.&nbsp;&nbsp; Deep expertise in bioanalytical assay development for biologics and small molecules, including PK, ADA, and biomarker assays.&nbsp;&nbsp; Strong understanding of regulatory requirements and experience supporting global regulatory submissions.&nbsp;&nbsp; Demonstrated ability to influence cross-functional teams and drive strategic initiatives.&nbsp;&nbsp; Excellent communication, organizational, problem-solving and project management skills.&nbsp; Experience with overseeing vendors.&nbsp; Experience in a fast-paced biotech environment.&nbsp;&nbsp; Track record of innovation and scientific contributions in bioanalysis.&nbsp; &nbsp; #LI-OnsiteMA Pay Range$241,530&mdash;$295,850 USDThe statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.&nbsp; The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Executive Director, Bioanalytical Development

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Director, US Commercial Business Operations is a critical role within the commercial organization, driving strategic initiatives and operational excellence to fuel business growth. Reporting to the Head of US Commercial Operations, this individual is a highly visible commercial leader responsible for building foundational capabilities from the ground up, including operational infrastructure, data strategy, management, and governance; commercial effectiveness program development and execution; and sales enablement. This role requires strong cross‑functional collaboration across commercial stakeholders in marketing, market access, patient services, finance, IT, and US Commercial leadership to ensure launch readiness and sustained execution. The Director, US Commercial Business Operations serves as a champion of innovation and operational efficiency, streamlining processes and enhancing collaboration with a patient‑first mindset. This is an individual contributor role requiring strong communication, self‑initiative, and consultative engagement skills.&nbsp; This role is based in Waltham, MA Primary Responsibilities Include: Operational Excellence and Business Analytics Establish scalable processes for forecasting, demand and sales planning, and performance tracking to ensure operational efficiency. Manage Veeva, BI tools, and other commercial technology systems to identify market trends, optimize resource allocation, and make data driven-informed decisions. In collaboration with Trade and Distribution lead and finance, create channel analytics to inform forecast demand. Collaborate with marketing operations for Medical/Legal Review Process logistics Partner with marketing operations on National, regional, and local meeting management. Lead automation of BI reporting for HQ, executive leadership and field in collaboration with IT commercial business partner. Embed AI tools and capabilities into key processes and workflows to improve efficiency, decision-making, and business outcomes. Scalable process for alignments, targeting, and Veeva call cycle planning. Lead for market access analytics and developing reports through requirement gathering with HUB, SP, SIP and data aggregator. Data Strategy, Management and Governance Implement and refine data strategy as needed. Oversee all data channels for US market, ensure quality, and set up processes to identify data issues Lead SP and data aggregator data integrity meeting process, setting weekly cross-functional team engagements. Ensure data quality and compliance with security and regulatory standards. Lead data processes and foster collaboration to align organizational goals while driving continuous improvement. Commercial Effectiveness and Execution-Field Enablement Lead field force programs and services, circle of excellence program development, award trip, and administration. Fleet program development and management. Optimize field enablement tools and materials for maximum field productivity. Education and Skills Requirements Bachelor’s degree and 10+ years of experience in biotech/pharma/life sciences in field sales, sales leadership, commercial business operations or strategy. Proven track record of success in launching rare disease neuromuscular, neurodegenerative or neurodevelopmental therapies. Strong leadership experience, managing vendors, and scaling commercial infrastructure. Strategic thinker with strong business acumen and results-oriented mindset Proficiency with commercial technology and software platforms, and data (CRM, BI tools, Snowflake, Boomi, SP &amp; SIP and HUB data) Excellent communication skills and problem-solving skills. Strong writing and verbal communication skills, including ability to present to senior management. #LI-OnsiteMA Pay Range$196,000&mdash;$240,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, US Commercial Business Operations

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Director, US Data and Advanced Analytics plays an instrumental role in building and synthesizing a data ecosystem to answer key business questions by generating recommendations that optimize Dyne’s readiness for neuromuscular rare disease launches. Reporting to the Head of US Commercial Operations, this individual is a highly visible commercial leader who tests, evaluates, and introduces advanced analytical techniques; leverages sophisticated analytical methodologies; and incorporates predictive analytics to inform decision‑making related to brand and channel strategies, patient journeys, promotional response, ROI measurement, demand forecasting, and omnichannel analytics. This role requires strong cross‑functional collaboration across commercial stakeholders in marketing, market access, patient services, finance, IT, and US Commercial leadership. The Director demonstrates advanced knowledge and proficiency in using large and complex data sets to drive innovative thinking that results in value creation. This is an individual contributor role that requires strong communication, self‑initiative, and consultative engagement skills. This role is based in Waltham, MA Primary Responsibilities Include: Lead the utilization of advanced analytical techniques (AI/ML, predictive modeling) in collaboration with IT, leveraging structured and unstructured data across market research, demand forecasting, promotional mix, ad-hoc analytics, and customer/market insights to inform US execution strategy. Deep understanding of real-world data, such as anonymized longitudinal patient claims data, lab/diagnostic testing data, EMR, to provide patient-level analytics Proficiency with claims data sets such as Komodo, IQIVA, Definitive Healthcare. Partner with I&amp;A lead for US market research and US forecasting. Lead market research, demand planning and forecasting for DMD and DM1 markets by end of 2026. In collaboration with IT, build a best-in-class data ecosystem to answer key business questions and create insightful visualizations, making sense of complex datasets and methodologies. Lead story development and presentation of commercial analytics to ensure stakeholder buy-in. Develop promotional marketing mix response process and omnichannel effectiveness analytics in collaboration with head of omnichannel and digital. Plan, direct, oversee and provide thought leadership for advanced analytical approaches, including artificial intelligence and machine learning Develop high quality solutions and answers to ad-hoc business questions with commercial and senior leadership. Lead KPI workshop identification to develop KPI dashboards and commercial scorecards. Leverage large and complex data from HUB, SP’s, SIP’s, data aggregator, claims, EMR and diagnostic to build a patient finding capability. Manage vendor relationships and overall project management with external vendors, IT commercial business partner, commercial leadership, brand teams, and other commercial stakeholders across the US commercial organization. &nbsp;Education and Skills Requirements: Bachelor’s degree and 10+ years of relevant experience, advanced quantitative analytics preferred. 7+ years of biotech/pharma/life sciences experience industry experience with relevant experience in commercial analytics, sales operations, predictive modeling, omnichannel analytics and patient level data analytics; consulting experience preferred Past rare disease launch experience preferred. Proven track record of developing and implementing AI and ML solutions. Relevant expertise using analytical tools such as excel, SAS, SQL, Snowflake, R or Python. In-depth understanding and experience using advanced analytical techniques to assess strategic business questions, resulting in value creation. Strong analytical and organizational skills experienced in managing multiple projects, analytical resources, vendors/consultants and cross-functional teams. Expertise working with patient level claims data sets and other large data sets. Ability to think strategically and anticipate future analytical trends. Excellent communication skills and problem-solving skills. Strong writing and verbal communication skills, including ability to present to senior management. Strong writing and verbal communication skills, including ability to present to senior management. #LI-OnsiteMA Pay Range$196,000&mdash;$240,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, US Data and Advanced Analytics

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The&nbsp;Senior&nbsp;Director,&nbsp;DMD&nbsp;Scientific and Medical Education&nbsp;Lead&nbsp;provides&nbsp;leadership for the planning,&nbsp;development, and execution of&nbsp;an integrated scientific communications&nbsp;strategy&nbsp;for Dyne’s&nbsp;Duchenne muscular dystrophy&nbsp;program. This role&nbsp;is responsible for&nbsp;defining long-term strategies that&nbsp;translate&nbsp;complex scientific,&nbsp;clinical, and real-world&nbsp;data into clear,&nbsp;accurate, and compliant communications for internal and external stakeholders, including healthcare professionals&nbsp;and&nbsp;payers.&nbsp;The ideal candidate brings deep expertise in strategic&nbsp;scientific communication planning&nbsp;and cross-functional leadership&nbsp;ensuring close partnership with&nbsp;other functions withing the Global Medical Affairs team, as well as&nbsp;with&nbsp;Clinical Development, Biostatistics, Research,&nbsp;HEOR,&nbsp;Commercial,&nbsp;and Corporate Communications to ensure cohesive planning and execution of Dyne’s scientific and medical education strategy.&nbsp; This role is based in Waltham, MA.&nbsp;&nbsp;Primary Responsibilities&nbsp;Include: &nbsp; Develop&nbsp;and lead the global scientific communications strategy&nbsp;for DMD&nbsp;aligned with&nbsp;program and&nbsp;corporate objectives&nbsp; Develop&nbsp;and ensure the execution of&nbsp;a&nbsp;long-term&nbsp;strategic publication&nbsp;plan, including&nbsp;integration of preclinical, clinical, and real-world evidence data into&nbsp;dissemination roadmaps and evidence-generation narratives, and&nbsp;maintain&nbsp;visibility into timelines,&nbsp;dependencies&nbsp;and risks to ensure on-time delivery&nbsp; Assist&nbsp;in developing Dyne’s overall congress strategy and presence, including planning medical booth assets, symposia, and presentations&nbsp; Plan and execute global medical communications initiatives (e.g., IME, roundtables) that support product strategy&nbsp; Serve as strategic advisor to cross-functional teams on scientific messaging and data interpretation&nbsp; Partner closely with Patient Advocacy and regional medical teams on the development of publications and educational materials for their respective audiences&nbsp; Manage agency partners and external vendors to deliver high-quality outputs&nbsp; Manage budgets and resources to support long-term planning and execution&nbsp; Mentor junior members of the team&nbsp; &nbsp; Education and Skills Requirements:&nbsp; Doctorate degree (MD, PhD, PharmD) with&nbsp;12+&nbsp;years of experience with a focus on rare diseases, neuromuscular experience, or related discipline&nbsp; Analytical skills, with&nbsp;a track record&nbsp;of delivering against goals while working in high performing, diverse teams&nbsp; Demonstrated success in&nbsp;operating&nbsp;effectively in highly matrixed organizations where influencing skills are critical to day-to-day success&nbsp; Experience in building strong and effective relationships with thought leaders&nbsp; Experience in managing vendor partners&nbsp; Excellent written and verbal communication skills&nbsp; Launch experience preferred&nbsp; Travel up to ~20%&nbsp; MA Pay Range$233,000&mdash;$285,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, DMD Scientific and Medical Education Lead

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Clinical Site Liaison&nbsp;is&nbsp;responsible for&nbsp;developing and nurturing strong Dyne Therapeutics – Clinical Trial Site relationships while also&nbsp;optimizing&nbsp;site performance, particularly enrollment, and overseeing CRO site management and&nbsp;monitoring&nbsp;activities, using a risk-based approach.&nbsp;The primary goal of this role is to build/support site relationships while also ensuring quality monitoring oversight and delivery of data of high integrity.&nbsp;The individual in this role&nbsp;is responsible for&nbsp;working directly with the internal study teams, CRO&nbsp;partners&nbsp;and clinical trial sites.&nbsp;&nbsp;Primary Responsibilities&nbsp;Include:&nbsp; Site&nbsp;Relationship&nbsp;Management&nbsp; Enhance the development and maintenance of&nbsp;Dyne’s&nbsp;relationships with clinical investigators&nbsp;and site staff&nbsp;&nbsp; Provide an interface among study sites, Dyne Therapeutics and CRO partners to create&nbsp;an optimal&nbsp;environment for clinical trials, enabling&nbsp;timely&nbsp;and high-quality output&nbsp; Coordinate regular, fit for purpose, communication with clinical sites to align interactions with CRO and relevant internal stakeholders to assure a harmonized approach to site relationship and&nbsp;optimize&nbsp;site performance and quality delivery&nbsp; May attend SIVs and Motivational/Booster visits/calls in collaboration with CRO partner&nbsp; &nbsp;Recruitment Support&nbsp; Maintain an operational knowledge of the protocol(s), answer site/CRO questions as applicable and&nbsp;assist&nbsp;in the escalation process in connecting site/CRO to Dyne Therapeutics personnel&nbsp; Leverage experience and deep insight from interactions with clinical sites to provide strategic input on effective recruitment, outreach, and optimization strategies.&nbsp; Maintain and&nbsp;assist&nbsp;with the development of plans and tools to carry out these strategies, as appropriate&nbsp; Monitoring Support&nbsp; In collaboration with CRO partners and as approved by the Clinical Operations&nbsp;Study&nbsp;Lead&nbsp;(COSL), perform on-site visits in support of continued site engagement and data quality,&nbsp;identify&nbsp;and remove barriers to performance and to oversee on-site outsourced monitoring activities&nbsp; Document and communicate observations from onsite monitoring activities (such as key areas of risks and noncompliance)&nbsp; Provide ongoing risk&nbsp;assessment review&nbsp;of available data resources, review the site performance/CRO monitoring performance to&nbsp;identify&nbsp;trends, risks, and opportunities.&nbsp; In collaboration with the&nbsp;COSL, perform review of monitoring visit reports (on-site and central review reports) completed by CRO partner&nbsp; Contribute to process improvements and knowledge/ sharing of best practices&nbsp; Education and Skills Requirements:&nbsp; Bachelor’s Degree or international equivalent&nbsp;required; Life Sciences preferred. Advanced degree highly desirable&nbsp; Strong knowledge of ICH/GCP&nbsp; At&nbsp;least&nbsp;8&nbsp;years of relevant clinical trial research experience&nbsp; Onsite/central monitoring and/or clinical lead/study-management experience&nbsp; Clinical site facing experience&nbsp;required&nbsp; Monitoring experience in rare disease preferred&nbsp; Biotech or pharma industry experience is&nbsp;required&nbsp; Experience overseeing/managing outsourced site management and monitoring activities&nbsp; Excellent verbal and written communication skills&nbsp; Excellent attention to details&nbsp; Ability to travel,&nbsp;30%&nbsp;or more&nbsp;frequently&nbsp;at times&nbsp;&nbsp; MA Pay Range$155,000&mdash;$190,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, Clinical Site Liaison

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: In this role, the&nbsp;VP,&nbsp;Commercial &amp; Corporate Counsel&nbsp;serves as counsel to the commercial organization and&nbsp;leads&nbsp;the corporate, contracts, and employment functions of the legal department. The VP,&nbsp;Commercial &amp; Corporate Counsel&nbsp;provides&nbsp;legal guidance on a wide range of commercialization issues as Dyne scales and prepares for the&nbsp;anticipated&nbsp;launches&nbsp;of its first therapies. These topics include advertising and promotion, compliance with FDA regulations, health care fraud and abuse laws, Value &amp; Access matters, patient support programs, data privacy, and various federal and state laws governing the pharmaceutical industry. The VP,&nbsp;Commercial &amp; Corporate Counsel&nbsp;also&nbsp;leads and manages&nbsp;corporate governance and public filing matters, contracting, and employment matters.&nbsp;&nbsp;&nbsp; This role is based in Waltham, MA&nbsp; Primary Responsibilities:&nbsp; Serve as counsel for Dyne’s&nbsp;commercial organization.&nbsp; Advise on&nbsp;global&nbsp;pricing, value &amp; access strategies, contracting, trade and&nbsp;distribution&nbsp;matters, and patient access programs.&nbsp; Assess legal risk related to federal and state laws including the Anti-Kickback Statute, False Claims Act, FDA promotional regulations, antitrust, privacy, and&nbsp;pricing&nbsp;transparency laws. Propose practical, compliant solutions aligned with business strategies.&nbsp; Lead and manage&nbsp;the corporate, contracting, and employment legal functions for Dyne&nbsp;including:&nbsp; Oversee&nbsp;and lead the drafting, review, and filing of SEC disclosures, including Forms 10-K, 10-Q, 8-K, and proxy statements. Ensure compliance with the Securities Exchange Act of 1934, Regulation FD, and relevant stock exchange rules. Support insider trading policy administration and public disclosure processes.&nbsp; Oversee and lead&nbsp;legal support for Board of Directors and committee meetings;&nbsp;oversee&nbsp;management of&nbsp;governance documents and corporate records; oversee legal aspects of the annual stockholder meeting and proxy development; advise on governance best practices.&nbsp; Advise on&nbsp;corporate transactions including&nbsp;partnerships,&nbsp;mergers, acquisitions, and financings.&nbsp;&nbsp; Business Partnership &amp; Leadership&nbsp;within the Legal team&nbsp; Provide mentorship and leadership to members of the Legal team.&nbsp; Serve as a proactive&nbsp;and collaborative&nbsp;partner with&nbsp;key functions including Commercial,&nbsp;Finance,&nbsp;Medical&nbsp;and Human Resources.&nbsp; Represent Legal on cross-functional&nbsp;project&nbsp;and governance teams to support launch readiness and commercial&nbsp;objectives.&nbsp; Support the Head of Legal and help&nbsp;mature Dyne’s&nbsp;commercial,&nbsp;corporate, contracting and employment&nbsp;capabilities&nbsp; Identify&nbsp;opportunities for process improvement and proactive legal risk management.&nbsp; Education, Knowledge &amp; Skill Requirements:&nbsp; JD from an accredited&nbsp;Law&nbsp;School; licensed to practice in at least one U.S.&nbsp;jurisdiction.&nbsp; 15+ years of&nbsp;global&nbsp;commercial and&nbsp;health care law&nbsp;ideally within a&nbsp;commercial stage&nbsp;global biotechnology company&nbsp;and a top-tier law firm&nbsp; Deep&nbsp;expertise&nbsp;in FDA regulations, U.S. health care laws, and federal health care programs;&nbsp;rare disease; product launches;&nbsp;familiarity with ex-U.S. frameworks.&nbsp; Strong understanding of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy&nbsp;&amp; security, and transparency laws.&nbsp; Demonstrated content review committee experience in the pharmaceutical industry.&nbsp; Experience advising on securities regulation, including securities law reporting, compliance and disclosure issues, shareholder meeting matters, stock exchange listing requirements, corporate governance, board matters, and executive and equity compensation&nbsp; Experience leading corporate transactions&nbsp; Proven success advising cross-functional teams (Commercial,&nbsp;Finance,&nbsp;Medical, Human Resources) on complex, time-sensitive matters.&nbsp; Skilled at balancing strategic legal guidance with practical business judgment in fast-paced, evolving environments.&nbsp; Exceptional communication, analytical, and project management skills with attention to detail and execution excellence.&nbsp; Collaborative leadership style and enterprise&nbsp;mindset that&nbsp;reinforces organizational culture and values.&nbsp; Experience thriving in a small, rapidly growing biotech or start-up environment with a solutions-oriented approach.&nbsp; MA Pay Range$296,000&mdash;$355,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Vice President, Commercial & Corporate Counsel

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director of Compliance&nbsp;provides&nbsp;compliance guidance on a wide range of commercialization issues as Dyne scales and prepares for the&nbsp;anticipated&nbsp;launch of its first therapies. These topics include HCP and patient engagement, disease‑state education, compliance with FDA regulations, health care fraud and abuse laws, Value &amp; Access matters, patient support programs, data privacy, and various federal and state laws governing the pharmaceutical industry.&nbsp; The Director of Compliance helps design and implement a global compliance program to ensure that Dyne&nbsp;complies with&nbsp;all applicable laws, regulations, and ethical codes where the company&nbsp;operates. The Director of Compliance works closely with Medical, Commercial, Regulatory Affairs, and G&amp;A colleagues. We&nbsp;seek&nbsp;a strategic, collaborative, solutions‑oriented leader with deep knowledge and experience. Prior rare‑disease and launch experience enables the Director of Compliance to help Dyne navigate the challenges of our first therapy launches.&nbsp; This role is based&nbsp;in&nbsp;Waltham, MA,&nbsp;without the possibility of being a remote role.&nbsp;&nbsp; &nbsp;Primary Responsibilities&nbsp;Include:&nbsp; Design and implement a comprehensive health care compliance program consistent with all laws, regulations,&nbsp;policies&nbsp;and industry standards.&nbsp; Establish and refresh corporate policies,&nbsp;procedures&nbsp;and guidelines to ensure compliant operations across all Commercial, Medical and&nbsp;research&nbsp;activities.&nbsp; Lead risk assessments to&nbsp;identify&nbsp;and prioritize compliance risks.&nbsp; Develop and deliver risk-based compliance training for employees.&nbsp; Develop and implement auditing &amp; monitoring plans and related dashboards.&nbsp; Lead confidential, thorough investigations into potential violations.&nbsp; Establish Compliance as an approachable, knowledgeable, practical, helpful, solutions-oriented business partner.&nbsp; Collaborate closely with the Franchise Counsel to&nbsp;align on&nbsp;consistent, actionable legal and compliance solutions.&nbsp; Champion Dyne’s core values and culture of integrity.&nbsp; Serve as a trusted advisor to senior leadership and cross-functional teams on business and compliance strategies.&nbsp; Perform&nbsp;additional&nbsp;duties as&nbsp;required.&nbsp; Education, Experience,&nbsp;and Skills Requirements:&nbsp; Advanced degree in law, business&nbsp;administration&nbsp;or related field.&nbsp; 10+ years of overall professional experience, including at least 7+ years of healthcare compliance experience, ideally within a global rare disease biotechnology company.&nbsp; Deep&nbsp;expertise&nbsp;in U.S. health care laws, federal health care programs, and therapy launches.&nbsp; Strong understanding of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy,&nbsp;and transparency laws.&nbsp; Experience supporting&nbsp;compliant patient engagement, HCP engagement, scientific exchange, and innovative patient support programs.&nbsp; Proven success advising cross-functional teams (Medical, Commercial, Regulatory, Technical Operations, and G&amp;A) on complex, time-sensitive matters.&nbsp; Skilled at balancing strategic&nbsp;compliance&nbsp;guidance with practical business judgment in fast-paced, evolving environments.&nbsp; Exceptional communication, analytical, and project management skills with attention to detail&nbsp;and execution&nbsp;excellence.&nbsp; Collaborative leadership style and enterprise&nbsp;mindset that&nbsp;reinforces organizational culture and values.&nbsp; Experience thriving in a small, rapidly growing biotech or start-up environment with a solutions-oriented approach.&nbsp; MA Pay Range$200,000&mdash;$240,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Compliance

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Vice President, Customer Experience leads Dyne’s nationwide field organization, setting strategic direction and driving operational execution for our first commercial launch. This role orchestrates cross-functional collaboration across key accounts, medical affairs, patient services, and reimbursement to ensure patients with neuromuscular diseases, including DMD, DM1, and FSHD, receive optimal care. The VP builds and directs a high-performing team focused on delivering Dyne’s innovative therapies to patients, starting with our lead candidate in DMD. Success requires exceptional leadership, deep launch expertise, and a strong understanding of market dynamics, customer insights, and the competitive landscape. This leader ensures seamless coordination across all field functions to position Dyne for sustained growth and impact. This is a field-based role. Key Responsibilities Sets the Strategy Craft a cohesive go-to-market strategy that resonates with the target audience, distinguishes Dyne from competitors, and creates market impact Implement business plans to achieve performance goals, including regional launch readiness reviews with senior leadership.&nbsp; Develop and implement national and regional account and marketing plans to achieve business objectives within the rare disease therapeutic area.&nbsp; Understand the specific market landscape and trends within each region to identify opportunities and adapt strategies.&nbsp; Develop and implement long-term strategies for growth and expansion within each region.&nbsp; &nbsp;Operational Execution &amp; Launch Excellence Drive cross-functional collaboration with Medical Affairs, Patient Services and Distribution, Commercial Operations, Market Access, Corporate Affairs, Human Resources, Compliance, Legal and Patient Advocacy Serve as the orchestrator for customer-facing teams to build strong relationships with healthcare providers, KOLs, payers, and other key stakeholders Builds and maintains strong relationships with key opinion leaders (KOLs), healthcare professionals (HCPs), and other stakeholders within sites of care Manage and grow key accounts across the nation, ensuring the successful adoption of Dyne’s rare disease products.&nbsp; Navigate the complex US access environment with innovative approaches and patient services support to ensure optimal patient access Ensuring customer satisfaction and addressing any issues within the region Ensuring that all activities and interactions comply with relevant regulations and guidelines.&nbsp; &nbsp;Business Performance &amp; Financial Management Develop and oversee financial plans for the region, including revenue maximization and budget management.&nbsp; Deliver on key performance indicators for appropriate KOL/HCP interactions, market access, and product adoption Ensure operational efficiency across all aspects of the region Allocate resources strategically to maximize impact and ROI People Leadership &amp; Development Build and inspire high-performing, cross-functional teams that drive innovation, excellence, and an entrepreneurial spirit. Motivate, empower and coach the team, delegating tasks and ensuring they meet performance expectations.&nbsp;&nbsp; Mentor regional team members to drive performance and development.&nbsp; Foster strong partnerships across functions to ensure aligned objectives and seamless implementation Education/Experience/Skills: Bachelor's degree with a minimum 20 years of progressive experience in Pharmaceutical/Biotech Rare disease commercial launch experience is required Prior experience leading a national sales organization in a biotech or pharma company is strongly preferred Culture builder &amp; talent magnet that attracts, hires, develops, retains, and promotes top talent; sets a people-first, performance-driven culture. Experience leading cross-functional teams in at least one other discipline (e.g., marketing, market access, patient services, clinical specialty or medical, other) is strongly preferred Exceptional leadership ability to lead and motivate teams, set clear goals, and deliver performance.&nbsp; Experience managing field organizations through change, innovation, or growth is highly valued. Excellent interpersonal and communication skills to build and maintain strong relationships with all stakeholders. Strong strategic thinking, business acumen, communication and enterprise leadership and ability to develop and execute operational plans, adapt to changing market conditions, and identify opportunities. Experience navigating complex regulatory and compliance environments including strong understanding of relevant policies guiding the Pharmaceutical Industry Innovative mindset with ability to drive transformation while delivering results. Willingness and ability to travel more than 50% of the time, including frequent overnight stays. MA Pay Range$300,000&mdash;$355,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

VP, Customer Experience

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Senior Director, Omnichannel &amp; Digital serves as a strategic leader responsible for developing and executing Dyne’s enterprise-wide omnichannel and digital engagement strategy across the Neuromuscular Disease (NMD) community. This role drives awareness of unmet needs in DMD and DM1, elevates Dyne’s visibility, and enables impactful engagement with HCPs, patients, and caregivers—both pre- and post-approval. This individual leads omnichannel planning, execution, and performance measurement. They collaborate cross-functionally with IT, Insights &amp; Analytics, US Marketing, Global and US Commercial Operations, and external partners to ensure alignment and agility across global and market-specific initiatives. This role ensures alignment between global initiatives while remaining agile to meet specific rules and regulatory-driven market needs. This role is based in Waltham, MA. &nbsp; Primary Responsibilities Include:&nbsp; Develop and execute a comprehensive omnichannel strategy in partnership with the Head of Commercialization, CDIO, and IT, embedded within Dyne’s broader launch preparedness and commercialization plans.&nbsp; Serve as Dyne’s subject matter expert and change agent for digital-first engagement, championing innovative programs across HCP and patient/caregiver channels.&nbsp; Lead omnichannel planning and execution across web, CRM, mobile, email, social, search, live/virtual events, and field-triggered channels.&nbsp; Partner with external agencies and vendors to deliver high-impact omnichannel tactics.&nbsp; Collaborate with Commercial, Medical, Advocacy, and Corporate Communications teams to translate unbranded and branded content into integrated digital engagement plans.&nbsp; Retrofit existing platforms and content to align with omnichannel strategy and ensure seamless integration across functions.&nbsp; Establish a robust performance tracking and analytics framework to measure channel effectiveness, field feedback, and inform data-driven optimization.&nbsp; Manage associated budgets and ensure compliance with Dyne’s financial processes.&nbsp; Stay current on industry trends, emerging technologies, and best practices to inform strategic planning and operational improvements.&nbsp; Education and Skills Requirements:&nbsp; Bachelor’s degree required; advanced degree in Digital Marketing, Communications, Life Sciences, or related field preferred.&nbsp; 12+ years of experience in biotech/pharma, including 8+ years in digital marketing and omnichannel strategy; experience in another industry is a plus.&nbsp; Proven track record of developing and executing omnichannel strategies for both HCP and patient audiences.&nbsp; Deep understanding of CRM, content orchestration, and marketing automation platforms (e.g., SFMC).&nbsp; Launch experience in pharma/biotech required, including familiarity with MLR/PRC processes and regulatory considerations.&nbsp; Knowledge of global data privacy regulations and compliance.&nbsp; Experience in rare disease preferred.&nbsp; Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.&nbsp; Minimal travel expected.&nbsp; #LI-OnsiteMA Pay Range$241,000&mdash;$275,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Omnichannel & Digital Engagement

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Senior Director, Pricing and Reimbursement is an experienced and strategic leader who is responsible for developing and executing global pricing and market access strategies to ensure optimal market positioning, pricing, and patient access solutions for our innovative products. This strategic leader establishes the overarching pricing and reimbursement strategy in alignment with the market access and commercialization strategy and has a proven track record of leading and coordinating strategic activities aimed at building, shaping, and accelerating access, securing reimbursement across global markets. They create effective and productive partnership with cross-functional partners to influence strategic clinical development and commercialization decisions, as well as driving and executing pricing and market access strategies to support the differential value of Dyne assets for payer and HTA stakeholders across all stages of the product lifecycle. The person in this role has strong leadership skills, a broad understanding and deep experience of global pharmaceutical markets (US &amp; global markets) and a proven track record of bringing products to market successfully. This role is based in Waltham, MA. &nbsp; Primary Responsibilities Include:&nbsp; Lead the development and implementation of global pricing and market access strategies for our late-stage and early pipeline products, including value proposition and messaging, payer engagement, early access programs, pricing strategies, market access plans, launch sequence optimization, pricing narratives, pricing policy and governance. Collaborate cross-functionally with HEOR, R&amp;D, Program Teams, Commercial, Medical Affairs, and other teams to integrate pricing, reimbursement and market access considerations throughout product lifecycles Develop and communicate compelling value story narratives and messaging for payers, health technology assessment (HTA) bodies, and other stakeholders Develop market access and pricing strategies to optimize product value and patient access globally, including innovative non-traditional market access solutions and contracting approaches to meet evolving payer needs Ensure integration of market access and pricing strategies into clinical development plans, brand plans, launch strategies, and launch sequencing decisions Provide pricing guidance and assumptions for strategic planning, annual forecasting, and brand budget processes Develop resources and materials to be leveraged by the local teams in the engagement with market access stakeholders Collect actionable insights through market research, expert input forums, advisory boards, early payer advice, and engagement with external stakeholders Represent the company externally on pricing and market access topics with payers, policymakers, and industry groups Build, lead and coach a high-performing global pricing and reimbursement team Represent Dyne pricing and market access on key senior-level governance forums, working groups, and teams Understand and abide by global compliance regulations Education and Skills Requirements:&nbsp; Advanced degree (PhD, PharmD, MD, or MBA) in a relevant field) 12+ years of experience in pharmaceutical/biotech industry with significant leadership experience in global pricing, reimbursement and market access roles 5+ years’ experience in people management, with experience building and leading high-performing global teams Deep understanding of global healthcare systems, pricing dynamics, and market access requirements Proven track record developing successful global pricing and market access strategies for specialty and rare disease products Excellent communication and presentation skills, with ability to influence senior leadership Experience building and leading high-performing global teams Strategic mindset with ability to navigate complex stakeholder environments Ability to travel globally on a regular basis #LI-OnsiteMA Pay Range$241,000&mdash;$275,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Pricing & Reimbursement

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Director, Hub Operations, is responsible for providing strategic and tactical oversight in the development, implementation and management of patient service programs in alignment with market needs and the patients we serve.&nbsp; The Director will work closely with Market Access, Marketing, Legal &amp; Compliance stakeholders to build and oversee the Hub and patient assistance programs.&nbsp; The Director is accountable for understanding and aligning to the brand strategy and to identify and recommend solutions for addressing barriers to patient access.&nbsp; This is a field-based role. Primary Responsibilities Include:&nbsp; Provide the strategic framework and guidance in the development and deployment of the patient access and support Hub Build and manage relationships with Hub partner who will perform benefits investigations and other related support to help ensure patients and health care providers understand coverage Manage day-to-day operations of Hub program Monitor Key Performance Indicators (KPIs) and Service Level Agreements (SLAs) to ensure Hub partner is meeting contractual obligations Exhibit ownership and accountability for all projects and internal assignments Proactively identify potential enhancements to the patient services programs while maintaining compliance Facilitate routine operational meetings to address potential barriers in access to therapy Maintain open communication throughout the organization Exercise sound judgment and oversight to ensure integrity and compliance with company policies in all activities and communications Monitors industry trends such as copay accumulators and maximizers, Alternative Funding Programs and incorporate into program design and execution Works closely with internal teams to ensure continuous feedback loop on program utilization and improvements Partner with Marketing on development of patient support program materials Facilitate business reviews with Hub partner Attend/staff/participate in meetings and/or conferences as requested by management Develop annual strategies and tactics plan in collaboration with leadership Education and Skills Requirements:&nbsp; Bachelor’s degree required 10+ years in healthcare, biotech, or pharmaceutical industry, including 4+ years in Hub Services, Patient Support Programs, Reimbursement, Access, Marketing, or Sales Proven experience in new product launches and rare disease markets Deep understanding of access and patient cost dynamics (Medicare Part B, Medicaid, commercial insurance) Ability to work independently, exercise sound judgment, and collaborate cross-functionally in dynamic environments Strong planning, organizational, and communication skills (oral and written) Entrepreneurial mindset with a passion for building, learning, and innovation Highly organized, detail-oriented, and committed to delivering quality results Skilled at translating complex concepts for diverse audiences Demonstrated problem-solving, intellectual curiosity, and ability to lead fast-paced projects with urgency Hands-on expertise and proven track record as a team player and collaborator Upholds the highest standards of professionalism, ethics, and integrity Travel up to 50% required #LI-OnsiteMA Pay Range$241,000&mdash;$275,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Hub Operations

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The US Medical Director of Medical Affairs leads&nbsp;Dyne’s medical strategy and execution within the United States, focusing on launch readiness, US-specific KOL engagement, congress planning and execution, and&nbsp;supports&nbsp;real-world evidence (RWE) initiatives. This role ensures alignment with global strategy while tailoring activities to US regulatory, payer, and healthcare landscapes.&nbsp;This role leads efforts to communicate and disseminate scientific and clinical information, engage with medical professionals in the&nbsp;field&nbsp;and contribute to the overall success of the company’s portfolio.&nbsp;The US Medical Director collaborates&nbsp;closely with&nbsp;Global Medical Affairs,&nbsp;US Commercial, Regulatory, Market Access, and Clinical teams to drive successful product introduction and lifecycle management in the US market.&nbsp;&nbsp; This role is located in our Waltham, MA office. Primary Responsibilities&nbsp;Include:&nbsp; Develop and execute&nbsp;US Medical Affairs strategy aligned with global&nbsp;objectives&nbsp;and US market needs&nbsp; Act as point person for all&nbsp;US&nbsp;Medical Affairs&nbsp;launch readiness activities, including&nbsp;working closely with&nbsp;global medical director and&nbsp;scientific communications on development of&nbsp;scientific platform development,&nbsp;local&nbsp;congress planning, and&nbsp;local&nbsp;medical education programs&nbsp; Support congress strategy execution in the US, including booth activities, symposia, and scientific presentations&nbsp; Work closely and with the Head&nbsp;of the&nbsp;Medical Science Liaison (MSL)&nbsp;team on&nbsp;US KOL engagement strategy:&nbsp;identify, map, and build relationships with key US experts&nbsp; Support&nbsp;insight collection and synthesis,&nbsp;and supporting the&nbsp;development of field material, working with the MSL team&nbsp; Develop US&nbsp;Medical Affairs advisory&nbsp;board&nbsp;strategy and&nbsp;organize&nbsp;and execute&nbsp;advisory boards and expert panels&nbsp; Work collaboratively with&nbsp;HCP and Patient&nbsp;Marketing&nbsp;as well as&nbsp;cross-functional stakeholders to integrate medical perspectives into brand strategy, ensuring alignment with scientific and commercial objectives&nbsp; Partner with Clinical Development&nbsp;and Clinical Operations&nbsp;to support US trial site engagement&nbsp;and recruitment strategies&nbsp; Working with&nbsp;the&nbsp;Global Medical Director,&nbsp;identify&nbsp;opportunities to generate&nbsp;real-world evidence (RWE) and&nbsp;phase IV data&nbsp;to address data gaps and support&nbsp;HCP&nbsp;and payer&nbsp;treatment decisions&nbsp; Ensure compliance with US regulatory and legal requirements for all medical activities&nbsp; Serve as subject matter expert on neuromuscular diseases and Dyne’s therapeutic platforms for US stakeholders&nbsp; Support&nbsp;the review and approval of externally&nbsp;presented materials through the Medical Review committee and Promotional Review Committee&nbsp;&nbsp; Act as a role model for integrity and compliance in all interactions&nbsp; Education&nbsp;and Skills Requirements:&nbsp; Doctorate degree (MD, PhD, PharmD) with experience in rare diseases; neuromuscular experience preferred&nbsp; Minimum&nbsp;8&nbsp;years of relevant experience in Medical Affairs within the US pharmaceutical/biotech industry&nbsp; Proven ability to lead US launch readiness and medical strategy execution&nbsp; Excellent communication and relationship-building skills with US KOLs and cross-functional teams&nbsp; Ability to interpret and communicate complex scientific data to diverse audiences&nbsp; Effective communication skills (written, verbal and presentation)&nbsp; Must be willing to travel up to 30%, inclusive of overnight and occasional weekends to meet with customers, internal stakeholders and attend relevant conferences&nbsp;&nbsp; Candidates must&nbsp;be authorized to&nbsp;work in the U.S.&nbsp; Positive team member who embodies Dyne’s Core Values&nbsp; Excitement about Dyne’s vision and mission&nbsp;&nbsp; Experience managing direct reports&nbsp;&nbsp; MA Pay Range$196,000&mdash;$285,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Medical Director, US Medical Affairs

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Associate Director, Clinical Quality Assurance plays a key role&nbsp;in ensuring that Dyne meets the highest standards of quality and compliance in our clinical efforts. This role&nbsp;is responsible for&nbsp;building and running a robust quality operations function across clinical sites and vendors, with a core focus on audit management,&nbsp;inspection&nbsp;readiness, and quality&nbsp;study support. This role&nbsp;drives quality assurance activities and&nbsp;work&nbsp;closely with cross-functional&nbsp;teams to enhance the quality of our clinical trials and ensure regulatory compliance. This role&nbsp;is responsible for&nbsp;the end-to-end lifecycle of clinical site audits, vendor audits, and regulatory inspections, while also leading SOP development and cross-functional quality projects.&nbsp; This is a hands-on&nbsp;role for someone who can&nbsp;contribute to strategy&nbsp;and&nbsp;operate&nbsp;at the&nbsp;tactical level,&nbsp;setting standards, driving execution, and ensuring the organization&nbsp;is always&nbsp;inspection ready.&nbsp; This&nbsp;role&nbsp;is&nbsp;based&nbsp;in&nbsp;Waltham,&nbsp;MA&nbsp;without&nbsp;the&nbsp;possibility&nbsp;of&nbsp;being&nbsp;a&nbsp;remote&nbsp;role.&nbsp;&nbsp; Primary&nbsp;Responsibilities&nbsp;Include&nbsp; Plan, execute, and oversee clinical site audits and vendor audits (routine, for-cause, and follow-up)&nbsp; Develop, implement, and continuously refine QA strategies, policies, and procedures to support clinical trial integrity&nbsp;&nbsp; Serve as the primary point of contact for audit activities, including audit preparation, conduct, reporting, and CAPA management&nbsp; Ensure&nbsp;timely&nbsp;identification, documentation, and resolution of audit findings&nbsp; Track audit trends and proactively drive continuous quality improvement&nbsp; Support inspection readiness activities across the organization, including mock inspections, readiness assessments, and&nbsp;training&nbsp; Act as a key quality representative during regulatory inspections, supporting responses, document requests, and inspection follow-up&nbsp; Maintain a state of ongoing inspection readiness rather than reactive preparation&nbsp; Author, review, and&nbsp;maintain&nbsp;SOPs, work instructions, and quality documentation aligned with&nbsp;GxP&nbsp;and applicable regulatory requirements&nbsp; Ensure SOPs are practical, scalable, and embedded into day-to-day operations&nbsp; Partner with cross-functional teams to ensure consistent interpretation and adoption of quality processes&nbsp; Lead and manage quality-related projects across clinical operations, vendors, and internal teams&nbsp; Collaborate closely with&nbsp;cross functional teams, and external partners&nbsp; Provide clear reporting, dashboards, and status updates to leadership on audit outcomes, risks, and remediation progress&nbsp; Collaborate with cross-functional teams to develop and implement corrective action plans to address audit findings and enhance quality&nbsp;&nbsp; Work in partnership with clinical operations, regulatory affairs, and data management teams to ensure alignment and consistency in quality standards and regulatory compliance&nbsp;&nbsp; Stay abreast of industry trends and regulatory updates to enhance Dyne’s QA framework and practices&nbsp; Lead initiatives aimed at improving clinical&nbsp;trial&nbsp;quality, efficiency, and operational excellence&nbsp;&nbsp; Education&nbsp;and&nbsp;Skills&nbsp;Requirements&nbsp; Bachelor’s degree in&nbsp;scientific, allied health, or medical field&nbsp;required&nbsp; 8+&nbsp;years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience)&nbsp; In-depth knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP,&nbsp;GxP), including safety reporting requirements&nbsp; Demonstrated experience managing clinical site audits,&nbsp;vendor audits, and&nbsp;managing quality assurance programs&nbsp;&nbsp; Experience supporting regulatory inspections (FDA, EMA, or equivalent).&nbsp; Skilled at&nbsp;effectively&nbsp;communicating quality events and outcomes to internal stakeholders&nbsp; Excellent interpersonal, verbal, and written communication skills&nbsp; Results-oriented, with the ability to set clear&nbsp;objectives, manage competing priorities, and meet dynamic timelines&nbsp; Flexible and creative problem solver with a proactive mindset&nbsp; Highly collaborative team player who fosters open communication and cross-functional cooperation&nbsp; Willingness to travel&nbsp;up to&nbsp;10%&nbsp;based on business needs&nbsp; MA Pay Range$155,000&mdash;$190,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, Clinical Quality Assurance

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The Director of Imaging Biomarkers leads&nbsp;the development and execution of innovative imaging strategies across Dyne’s therapeutic programs.&nbsp;This&nbsp;pivotal&nbsp;role&nbsp;will&nbsp;ensure&nbsp;that imaging biomarker strategies are scientifically rigorous, clinically relevant, and conducive to robust therapeutic development. The person in this&nbsp;role focuses on enhancing the understanding of disease&nbsp;mechanisms,&nbsp;patient populations,&nbsp;evaluating therapeutic efficacy, and supporting clinical&nbsp;trial&nbsp;designs through innovative imaging approaches.&nbsp;This role is critical to linking early phase research to clinical development,&nbsp;providing&nbsp;essential insights that drive decision making.&nbsp;The person in this role&nbsp;leverages&nbsp;their&nbsp;expertise&nbsp;in various imaging modalities to develop novel biomarker applications that assess therapeutic efficacy, drive patient-centric trial designs, and&nbsp;facilitate&nbsp;regulatory approval processes.&nbsp;This role combines scientific depth with strategic vision, driving the discovery, validation, and application of advanced imaging modalities to enable precision medicine and accelerate drug development. The&nbsp;person in this role&nbsp;serves&nbsp;as a trusted expert and collaborative leader, fostering innovation and ensuring scientific rigor in both preclinical and clinical settings.&nbsp;&nbsp; This role is based in Waltham, MA.&nbsp; &nbsp; Primary Responsibilities&nbsp;Include:&nbsp; Collaborate with cross-functional&nbsp;teams including clinical development, biostatistics, and regulatory affairs to&nbsp;ensure&nbsp;that imaging biomarkers are effectively integrated into clinical trial protocols&nbsp; Enable the delivery of high-quality data supporting both internal decision making and external communications with stakeholders, including regulatory authorities&nbsp;&nbsp; Define and execute the imaging biomarker strategy aligned with clinical and translational objectives&nbsp; Serve as the subject matter expert for imaging biomarkers across&nbsp;pre-clinical&nbsp;and clinical programs&nbsp; Lead the&nbsp;development, validation, and qualification of imaging biomarkers for disease characterization, patient stratification, and pharmacodynamic assessment&nbsp; Partner with Clinical Development, Translational Biomarkers, Biostatistics, Data Management and Regulatory teams to integrate imaging biomarkers into Dyne clinical trials&nbsp; Evaluate and implement&nbsp;cutting-edge&nbsp;imaging technologies (e.g., MRI, PET, CT, ultrasound, optical imaging)&nbsp; Ensure compliance with regulatory standards for imaging biomarker development and qualification&nbsp; Collaborate with external imaging CROs, academic institutions, and technology vendors to deploy imaging biomarkers into Dyne clinical trials&nbsp; Oversee vendor selection and budget management for imaging-related activities&nbsp; Manage imaging biomarker operations in clinical studies including protocol development, support site training, and data quality assurance&nbsp; Foster a culture of innovation and scientific rigor&nbsp; Education and Skills&nbsp;Requirements:&nbsp; Ph.D., M.D., or equivalent in Biomedical&nbsp;Engineering,&nbsp;Medical Physics, Radiology, or related&nbsp;scientific disciplines&nbsp; 10+ years of experience in imaging biomarker development within pharma, biotech, or academic research&nbsp; Blend of technical knowledge, scientific acumen, and strategic vision to foster collaborations with academic institutions, industry partners, and clinical&nbsp;experts&nbsp;&nbsp; Deep scientific&nbsp;expertise&nbsp;in at least one major imaging modality&nbsp;(preferably MRI)&nbsp;and a strong understanding of image acquisition, processing, and analysis&nbsp; Proven&nbsp;track record&nbsp;in applying imaging biomarkers in clinical trials and regulatory submissions&nbsp; Expertise&nbsp;in&nbsp;quantitative imaging methodologies, image analysis software, and&nbsp;imaging&nbsp;data interpretation&nbsp; Strong leadership and project management skills with ability to influence across functions&nbsp; Excellent communication and presentation skills&nbsp; Preferred Experience:&nbsp; Familiarity with AI/ML approaches for image analysis&nbsp;to improve efficiency, accuracy, and uncover complex patterns in imaging data&nbsp; Understanding and implementation of digital biomarkers using wearables, sensors, or other digital health technologies&nbsp; Knowledge of disease-specific imaging biomarkers (e.g., neurology, cardiology&nbsp;or neuromuscular)&nbsp; MA Pay Range$196,000&mdash;$240,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Imaging Biomarkers

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role&nbsp;Summary:&nbsp; The Director, Trade Relations (DTR), serves as the lead point of contact for Trade Relations activities across key channel accounts. The DTR is responsible for managing weekly customer Dyne product purchases and Trade customer inventories. They are responsible for developing, maintaining, and executing Trade customer business plans that deliver on distribution agreements. The DTR works with Management to assist with any Dyne product, pharmacy, or other issues that may arise.&nbsp; This role is a field-based role.&nbsp;&nbsp;&nbsp; Primary Responsibilities:&nbsp; Execute distribution strategy and maximize channel partner opportunities&nbsp;in accordance with&nbsp;product labeling and Company policies&nbsp; Develop and grow business partnerships within designated accounts and ensure the proper purchasing,&nbsp;stocking&nbsp;and inventory of&nbsp;Dyne&nbsp;products to achieve performance goals&nbsp;&nbsp; Analyze&nbsp;and understand trade customer business and align&nbsp;Dyne&nbsp;priorities to create Trade customer plans that deliver results that contribute to the defined business objectives&nbsp; Monitor Trade customers adherence to Distribution Services Agreements and&nbsp;act&nbsp;as&nbsp;appropriate (monitor customer contracts, service fees, 852 &amp; 867&nbsp;data&nbsp;and market share)&nbsp; Review and&nbsp;monitor&nbsp;daily Trade Sales to ensure purchases are aligned with demand&nbsp; Collaborate with&nbsp;Supply Chain&nbsp;to review and&nbsp;monitor&nbsp;all returns to ensure they occur&nbsp;in accordance with&nbsp;the&nbsp;Dyne&nbsp;Returns Policy&nbsp; Identify&nbsp;opportunities and barriers to ensure corporate success&nbsp; If applicable, negotiate and contract with all&nbsp;appropriate channel&nbsp;accounts, including Site&nbsp;of Care&nbsp;&nbsp; Provide leadership and development to internal and external matrix teams to support strong relationships&nbsp;&nbsp; Maintain open communication throughout the organization&nbsp;&nbsp; Review and analyze contracted Trade customers’ performance and communicate account performance broadly with key internal stakeholders&nbsp; Exercise sound judgment and oversight to ensure integrity and compliance with company policies in all activities and communications&nbsp; Attend/staff/participate&nbsp;in meetings and/or conferences as requested by management&nbsp; The employee will&nbsp;be responsible for&nbsp;developing and implementing his/her own business plans&nbsp; Foster&nbsp;Dyne&nbsp;core values and leadership behaviors&nbsp; Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; Bachelor’s degree&nbsp;required&nbsp; A minimum of 10&nbsp;years of pharmaceutical industry experience&nbsp; 5+&nbsp;years’&nbsp;successful experience in Trade and Distribution (contracting and negotiation experience&nbsp;required)&nbsp; Working knowledge of Trade customer segments&nbsp;and&nbsp;distributors&nbsp;&nbsp; Ability to work independently and make decisions, but with the knowledge of the situations where supervisory input is essential&nbsp; Strong interpersonal skills, ability to develop strong working relationships and work collaboratively&nbsp; Fosters innovation in account approaches and practices&nbsp; Excellent planning and organizational skills to work within date-sensitive deadlines&nbsp; Ability to work cross-functionally in a highly dynamic environment&nbsp; Recent launch and&nbsp;Rare&nbsp;disease experience&nbsp;preferred&nbsp; Strong&nbsp;track record&nbsp;of collaboration and leadership of key initiatives&nbsp; Cross-functional project management experience&nbsp; Travel up to 50%&nbsp;required&nbsp; &nbsp;MA Pay Range$188,000&mdash;$230,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Trade Relations

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The&nbsp;Senior Manager, Clinical&nbsp;Programming&nbsp;is responsible&nbsp;for&nbsp;overseeing and managing programming activities related to clinical trial data.&nbsp;The person in this role&nbsp;will&nbsp;ensure high-quality management of clinical trial data through effective programming strategies, driving best practices in programming, and ensuring that all clinical data is captured, processed, and reported to meet regulatory expectations and internal standards.&nbsp;This role collaborates closely with cross-functional teams, including clinical operations, biostatistics, and data management, to&nbsp;facilitate&nbsp;the successful execution of clinical trials. The person in this role&nbsp;leverages&nbsp;their&nbsp;expertise&nbsp;in programing and data management to create robust analytical databases, support regulatory submissions, and contribute to clinical study reports that&nbsp;showcase&nbsp;the efficacy and safety of our therapies.&nbsp; This role&nbsp;leads&nbsp;Clinical Programming&nbsp;projects and initiatives&nbsp;by&nbsp;navigating complex problems in support of&nbsp;Electronic Data Capture (EDC), external&nbsp;data handling, and data visualization.&nbsp;&nbsp;This role&nbsp;performs&nbsp;programming&nbsp;tasks from study start-up to close-out according to the&nbsp;Standard&nbsp;Operating&nbsp;Procedures&nbsp;(SOPs),&nbsp;International Council for&nbsp;Harmonisation&nbsp;- Good Clinical Practice (ICH-GCP),&nbsp;and all applicable regulatory requirements.&nbsp;&nbsp; This role is based in Waltham, MA.&nbsp; Primary Responsibilities Include:&nbsp; Oversee&nbsp;assigned&nbsp;day-to-day&nbsp;clinical&nbsp;programming&nbsp;activities, timelines,&nbsp;and deliverables&nbsp;for assigned projects&nbsp; Collaborate with clinical operations, biostatistics, and data management teams to develop project timelines and ensure alignment of programming deliverables with clinical study objectives&nbsp; Monitor project progress,&nbsp;identify&nbsp;potential issues, and implement solutions to mitigate risks&nbsp; Provide technical and business&nbsp;expertise&nbsp;in support of data deliverables&nbsp; Ensure compliance with&nbsp;internal polices,&nbsp;SOPs,&nbsp;and Work Instructions&nbsp;as well as external regulatory&nbsp;requirements related to clinical data management and programming&nbsp;&nbsp; Conduct quality checks and audits of programming deliverables to guarantee accuracy and integrity&nbsp; Identify&nbsp;opportunities for process improvements&nbsp;within clinical programming and data management practices and implement changes to enhance efficiency and quality&nbsp; Effectively interact with vendors&nbsp; Anticipate internal business challenges and successfully drive towards the best solution for the organization&nbsp; Participate in&nbsp;effective planning and execution of&nbsp;programming&nbsp;tasks&nbsp;&nbsp; Ensure timeliness and quality of data&nbsp;report&nbsp;deliverables in collaboration with&nbsp;Clinical Data Management&nbsp;team members and cross-functional&nbsp;colleagues&nbsp; Enable consistent&nbsp;programming&nbsp;approaches, standards&nbsp;adoption,&nbsp;and best practices&nbsp; Work closely with&nbsp;stakeholders to support data analysis and reporting needs&nbsp; Participate in initiatives around process development, standardization, and technology&nbsp; Contributes&nbsp;to&nbsp;selection&nbsp;and use of complex&nbsp;programming solutions to enhance clinical data collection&nbsp;and reporting&nbsp; Provide oversight of&nbsp;programming&nbsp;tasks performed by&nbsp;third-party vendors and data management&nbsp;Contract Research Organizations (CROs)&nbsp;as assigned&nbsp; Stay current with emerging technologies and methodologies relevant to the role&nbsp; Education and Skills Requirements:&nbsp; 6+ years of experience clinical&nbsp;programming with a focus on&nbsp;clinical&nbsp;data management and analysis within the pharma/biotech industry&nbsp; Bachelor’s degree in life science or related discipline&nbsp;required,&nbsp;advanced&nbsp;degree preferred&nbsp; Has in-depth&nbsp;knowledge&nbsp;of clinical database design, data standards, and data output&nbsp;programming&nbsp;expertise&nbsp; Demonstrates ability to&nbsp;anticipate&nbsp;internal business challenges and successfully drives towards the best solution for the organization&nbsp; Ability&nbsp;to perform&nbsp;short term tactical planning,&nbsp;typically&nbsp;for&nbsp;a&nbsp;6-month&nbsp;horizon&nbsp; Able to work in a&nbsp;highly matrixed,&nbsp;fast-paced environment with changing priorities and deadlines&nbsp; Highly organized and detail oriented&nbsp; Demonstrates&nbsp;strong&nbsp;collaboration&nbsp;skills&nbsp;with&nbsp;external&nbsp;service&nbsp;providers&nbsp;and&nbsp;cross-functional&nbsp;teams&nbsp; Experience with&nbsp;project management and meeting facilitation skills&nbsp; Able to manage time effectively and prioritize&nbsp; GCP knowledge&nbsp; Demonstrated experience in writing professional correspondence and clinical study documentation&nbsp; Data modeling, listing, and visualization development experience with&nbsp;elluminate&nbsp; EDC&nbsp;experience&nbsp;in various EDC systems,&nbsp;e.g.,&nbsp;Medidata Rave&nbsp; SAS programming experience a plus&nbsp; Strong working knowledge of&nbsp;CDISC Standards (CDASH,&nbsp;SDTM,&nbsp;ADaM)&nbsp; Strong understanding of clinical trial data&nbsp; Strong communication&nbsp;skills&nbsp;both verbal and written, with the ability to collaborate effectively with diverse teams&nbsp; Excellent problem-solving&nbsp;abilities and attention to detail&nbsp; MA Pay Range$143,000&mdash;$175,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Manager, Clinical Programming

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: As Dyne advances toward commercial launch across multiple therapy areas, we are seeking an experienced Business Strategy and Operations leader to play&nbsp;a central role&nbsp;in shaping and executing our transition from late-stage development to a fully integrated commercial company.&nbsp; The Director,&nbsp;Business Strategy &amp; Operations&nbsp;-&nbsp;Commercialization&nbsp;will play a critical role in enabling the Commercial organization to&nbsp;operate&nbsp;with clarity, alignment, and executional excellence as Dyne advances toward launch. Acting as a senior strategic and operational partner to the Chief Commercial Officer, this leader ensures that commercial priorities are translated into well‑defined, coordinated, and measurable action across the organization. This role sits at a key intersection of strategy, operations, and cross‑functional leadership, ensuring that commercial perspectives, priorities, and readiness are clearly embedded in key priority projects and initiatives. The role provides strong operational leadership and continuity to&nbsp;establish&nbsp;a world class CCO team, helping translate commercial strategy into coordinated action across the organization.&nbsp;The Director will help&nbsp;establish&nbsp;the systems, processes, and operating rhythm needed to drive commercial readiness, support the CCO and Commercial Leadership Team, and ensure the organization&nbsp;remains&nbsp;focused on the highest‑value priorities. They will&nbsp;anticipate&nbsp;needs, connect workstreams, and bring structure and consistency to a rapidly evolving environment.&nbsp; The ideal candidate brings significant biotech experience, strong strategic and analytical capabilities, and excellent judgment. They are comfortable navigating ambiguity, influencing without authority, and simplifying complexity for senior audiences. This is a high‑impact role with broad visibility across the enterprise, suited for a leader who thrives in a fast‑paced, high‑growth setting and is energized by building and enabling high‑performing teams.&nbsp; This is a full-time position based in Waltham, MA.&nbsp; &nbsp;Primary Responsibilities&nbsp;Include:&nbsp; Partner closely with the CCO to translate commercial strategy and priorities into actionable and measurable plans, ensuring clarity, structure, and consistency across initiatives.&nbsp;&nbsp; Establish and manage the operating rhythm for the Commercial organization, including leadership forums, governance processes, decision-focused meetings, and business reviews that drive alignment and follow-through.&nbsp; Lead and coordinate high‑priority, cross‑functional initiatives essential to commercial readiness, serving as the central connector between Commercial and partner functions with clear roles, responsibilities, and timelines.&nbsp; Develop and deliver high‑quality executive materials, including Board updates, enterprise presentations, town hall content, and cross-functional communications in partnership with Corporate Affairs.&nbsp; Support preparation and coordination for the CCO’s engagement with key external stakeholders, such as KOLs, HCPs, patient advocacy groups, strategic partners,&nbsp;and internal senior leaders.&nbsp;Ensure interactions are well-prepared, coordinated, and grounded in a clear understanding of priorities and context.&nbsp;&nbsp; Drive operational excellence through&nbsp;OKRs&nbsp;(objectives&nbsp;and key results for the CCO team), dashboards, performance tracking,&nbsp;and business review processes, providing transparency on progress, dependencies, risks, and resource needs.&nbsp; Promote alignment, communication, and collaboration across Commercial and partner functions to ensure connectivity between strategy and execution.&nbsp; Help strengthen Commercial team culture by reinforcing collaboration, accountability, and clear communication as the organization grows and prepares for launch.&nbsp; Leadership Characteristics&nbsp; Personal leadership characteristics will be critical to succeed&nbsp;in this role. The successful individual will be highly self-directed, with the judgment, energy,&nbsp;diligence&nbsp;and resilience&nbsp;required&nbsp;to&nbsp;operate&nbsp;effectively in a high-growth, fast-paced biotechnology environment. They will bring a calm, confident leadership presence,&nbsp;strong communication&nbsp;skills, well-articulated,&nbsp;and the ability to influence and align stakeholders across the organization without formal authority.&nbsp; Consistent with Dyne Therapeutics’ values and patient-centered culture, the individual must&nbsp;demonstrate&nbsp;a genuine commitment to listening to, learning from, and acting in the best interests of the patient communities and shareholders Dyne serves.&nbsp;&nbsp; A natural alignment with Dyne Therapeutics’ values, including accountability, collaboration, and a deep respect for the needs and experiences of patients and their families.&nbsp; The maturity and discretion&nbsp;required&nbsp;to handle sensitive information and complex organizational dynamics.&nbsp; Education, Experience,&nbsp;and Skills Requirements:&nbsp; 10+ years of progressive experience in biotechnology or pharmaceuticals.&nbsp; Bachelor’s degree&nbsp;required; advanced degree (MBA, PharmD, PhD) preferred.&nbsp; Experience supporting at least two successful rare disease&nbsp;product&nbsp;launches&nbsp;in a commercial, strategic, or operational leadership capacity.&nbsp; Strong cross-functional leadership experience in high-growth, dynamic environments.&nbsp; Exceptional communication, organization, and influencing skills; able to simplify complex topics for senior audiences.&nbsp; Highly self-directed and effective in ambiguity; strong judgment, prioritization, and follow-through.&nbsp; Demonstrated ability to handle confidential information with discretion and build trusted relationships at all levels.&nbsp; Thrives in dynamic, stretching environments with evolving needs.&nbsp; Ability to travel as needed; up to 25%&nbsp; MA Pay Range$188,000&mdash;$230,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Business Strategy & Operations - Commercialization

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary: The&nbsp;VP,&nbsp;DMD&nbsp;Commercial Asset&nbsp;Lead&nbsp;(CAL)&nbsp;is a passionate&nbsp;driver for&nbsp;maximizing the value&nbsp;of&nbsp;Dyne’s DMD&nbsp;commercial&nbsp;assets&nbsp;with a global perspective, who brings adaptable leadership&nbsp;to&nbsp;develop and implement commercialization&nbsp;strategies to maximize the&nbsp;reach and&nbsp;value&nbsp;creation&nbsp;of&nbsp;Dyne’s DMD&nbsp;commercial&nbsp;assets&nbsp;in the&nbsp;neuro muscular&nbsp;portfolio.&nbsp;&nbsp; This&nbsp;mandate&nbsp;includes market analysis, competitive positioning,&nbsp;launch readiness and&nbsp;execution&nbsp;and input into lifecycle&nbsp;management&nbsp;in the&nbsp;relentless pursuit of long-term success&nbsp;in bringing the asset to&nbsp;patients&nbsp;globally.&nbsp;The&nbsp;CAL&nbsp;is a highly visible leadership role.&nbsp;As a key member of&nbsp;an&nbsp;experienced&nbsp;Program&nbsp;Team,&nbsp;the&nbsp;CAL&nbsp;will&nbsp;work with the&nbsp;cross-functional team&nbsp;to&nbsp;influence&nbsp;and shape&nbsp;the Program strategy. The&nbsp;CAL leads all efforts in&nbsp;defining the commercialization strategy, strategic imperatives, critical success factors,&nbsp;executional&nbsp;priorities,&nbsp;and launch efforts&nbsp;together with the launch teams of the affiliates,&nbsp;bringing both a 'future-orientation' toward the&nbsp;goal&nbsp;of broad, global access for patients in need, and a "pragmatic-orientation" to chart the path, mitigate risks, cultivate options.&nbsp;The&nbsp;CAL&nbsp;collaborates&nbsp;with&nbsp;program team,&nbsp;functional&nbsp;leads&nbsp;and affiliate teams&nbsp;to achieve a&nbsp;differentiated product profile, competitive label,&nbsp;broad&nbsp;reimbursement&nbsp;and&nbsp;highly successful&nbsp;launches&nbsp;globally&nbsp;starting with the US launch.&nbsp;&nbsp; The&nbsp;CAL, as a&nbsp;member of the program team, is&nbsp;responsible&nbsp;for&nbsp;securing&nbsp;commercialization&nbsp;and&nbsp;works hand in hand&nbsp;in strong&nbsp;partnership&nbsp;with&nbsp;the Program Lead,&nbsp;the&nbsp;Head of Commercialization, all functional&nbsp;leaders&nbsp;and the&nbsp;affiliate launch teams.&nbsp; This role is&nbsp;based&nbsp;onsite in Waltham, MA.&nbsp;&nbsp; &nbsp;Primary Responsibilities&nbsp;Include:&nbsp; Define&nbsp;global&nbsp;asset commercialization&nbsp;strategy&nbsp;and plan&nbsp;to achieve milestones and timelines&nbsp;for successful launches&nbsp; As a key member of the Program Team&nbsp;and Head of DMD Commercial Sub Team,&nbsp;they&nbsp;ensure that all key pillars for successful commercialization for the assets&nbsp;are secured –&nbsp;starting with differentiation in endpoints to achieve a competitive product profile/label, regulatory strategy, filing strategy,&nbsp;with&nbsp;value&nbsp;&amp;&nbsp;access&nbsp;to secure&nbsp;the&nbsp;value proposition for the assets&nbsp;and&nbsp;achieve reimbursement&nbsp;in US and at the right time&nbsp;globally, partner with&nbsp;supply,&nbsp;medical, marketing, digital&nbsp;and&nbsp;the&nbsp;data team to prepare successful launch strategy and&nbsp;execution&nbsp;for all key markets&nbsp;starting with US.&nbsp;&nbsp; Provide input and&nbsp;expertise&nbsp;to a&nbsp;robust and well-understood&nbsp;program strategy&nbsp;with&nbsp;the&nbsp;key&nbsp;objective&nbsp;of&nbsp;gaining&nbsp;the approvals&nbsp;of&nbsp;potentially&nbsp;life-changing medicines&nbsp;for&nbsp;patients&nbsp;around the world&nbsp;to generate value for patients and shareholders&nbsp;and&nbsp;maximize&nbsp;topline&nbsp;growth.&nbsp; Structure and&nbsp;facilitate&nbsp;critical cross-functional decisions on commercialization aspects of the asset within Program Teams and senior leadership teams, bringing all relevant perspectives to bear while driving to efficient decisions in a fast-paced environment.&nbsp; Working with&nbsp;cross-functional&nbsp;launch&nbsp;team&nbsp;in&nbsp;key markets, starting with the US&nbsp;team,&nbsp;and&nbsp;Strategic&nbsp;Commercialization&nbsp;Partners&nbsp;to&nbsp;secure&nbsp;reimbursement and successful launches, by&nbsp;propelling&nbsp;successful launch execution&nbsp;from one country to the&nbsp;other.&nbsp;&nbsp; In close collaboration with the Program Lead and Head of Commercialization, consider and advocate for the needs of the commercial asset in the context of Dyne’s corporate strategy and priorities.&nbsp;&nbsp; Drive preparation and presentation of materials for Board of Directors&nbsp;on&nbsp;asset&nbsp;commercialization topics&nbsp; Maintain clear, open, and proactive communication with the senior leadership team and other stakeholders&nbsp;regarding&nbsp;commercialization&nbsp;strategy, status, priorities,&nbsp;risks&nbsp;and needs, and&nbsp;facilitate&nbsp;appropriate&nbsp;decision-making.&nbsp; Keep abreast of&nbsp;competitor&nbsp;landscape&nbsp;and development in the fields of muscle diseases and oligonucleotide drug discovery and&nbsp;development.&nbsp; Build visible, constructive, and credible presence within&nbsp;the&nbsp;DMD&nbsp;community&nbsp;including&nbsp;with&nbsp;KOLs, the holistic teams engaged in patient care&nbsp;and patient community.&nbsp;&nbsp; Participate in business development activities, as needed, including opportunity evaluations and due&nbsp;diligence.&nbsp; Provide&nbsp;a motivating leadership example within Dyne more broadly during periods of rapid growth.&nbsp; Foster a culture of collaboration, innovation, discovery, and&nbsp;cutting-edge&nbsp;research.&nbsp; Focused on scientific excellence, open communication, and&nbsp;continuous&nbsp;improvement.&nbsp; Role&nbsp;model&nbsp;Dyne’s&nbsp;core values.&nbsp;&nbsp; &nbsp; Education and Skills Requirements:&nbsp; Bachelor’s degree in a relevant scientific, medical, or business discipline&nbsp;required; advanced degree (MD, PhD, PharmD, MBA, or Master’s in Life Sciences)&nbsp;strongly&nbsp;preferred.&nbsp; Minimum of 20 years of experience in the biopharmaceutical industry.&nbsp; 15+ years of commercialization and cross-functional leadership experience within the biopharmaceutical industry, including substantial involvement in&nbsp;clinical&nbsp;development strategy, regulatory interactions, filing preparation, and lifecycle planning.&nbsp; Extensive experience leading global product launches, including development of launch strategy, execution, and cross-functional commercialization planning.&nbsp; Rare disease launch experience&nbsp;strongly&nbsp;preferred;&nbsp;neuromuscular disease experience&nbsp;highly&nbsp;advantageous.&nbsp; Proven&nbsp;track record&nbsp;of:&nbsp; Delivering on business&nbsp;objectives&nbsp;in&nbsp;fast--paced,&nbsp;highstakes&nbsp;environments.&nbsp; Steering assets from&nbsp;late stage&nbsp;development through approval and launch.&nbsp; Influencing global and U.S. market access, value evidence generation, and reimbursement readiness.&nbsp; Experience collaborating closely with clinical development, medical affairs, supply chain, marketing, digital/data teams, and affiliate launch organizations.&nbsp; Expertise&nbsp;in global asset commercialization, including competitive positioning, launch sequencing, market shaping, and lifecycle strategy.&nbsp; Ability to synthesize scientific, clinical, regulatory, and market data to guide asset and commercialization strategy.&nbsp; Fluency with digital launch tools, analytics platforms, and&nbsp;data driven&nbsp;decision-making.&nbsp; Entrepreneurial,&nbsp;self-driven&nbsp;leader capable of articulating a compelling vision and mobilizing&nbsp;high performing&nbsp;cross functional&nbsp;teams.&nbsp; Strong&nbsp;people&nbsp;leadership skills with the ability to coach, influence, and inspire diverse functional experts.&nbsp; Exceptional communication skills, including clear and effective engagement with executive leadership, affiliates, external partners, Boards of Directors, and patient communities.&nbsp; Proven ability to build strong, credible relationships with KOLs, advocacy groups, payers, regulators, and other key stakeholders.&nbsp; Comfortable leading through ambiguity, adapting to evolving priorities, and driving alignment in a dynamic environment.&nbsp; High integrity,&nbsp;strong&nbsp;patient centric&nbsp;mindset, and alignment with Dyne’s core values.&nbsp; Strong sense&nbsp;of urgency with the ability to pace and prioritize workstreams in competitive and&nbsp;fast-moving&nbsp;environments.&nbsp; Transparent, inclusive communicator with a collaborative leadership style.&nbsp; MA Pay Range$272,000&mdash;$340,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

VP, DMD Commercial Asset Lead

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary:&nbsp; The Senior Director, Dyne Patient Access and Education Team leads Dyne’s field-based Nurse Case Managers and Field Reimbursement Managers, who support patients, caregivers, and healthcare providers throughout the treatment journey. This national leader builds, inspires, and develops a high‑performing team responsible for patient and caregiver engagement, navigation of complex access processes, and successful post-prescribing conversion through first infusion and beyond. The Senior Director collaborates cross-functionally and externally to simplify access to patient care through a seamless, compassionate, and compliant support experience.&nbsp; This role is critical in shaping how Dyne engages with families, providing education about Dyne therapies and continuous support through the access and onboarding experience. It&nbsp;represents&nbsp;a unique opportunity for a patient‑focused leader to help bring transformative therapies to the patients who need them.&nbsp; This is a field-based role.&nbsp; &nbsp;Primary Responsibilities:&nbsp; Lead and develop high-performing&nbsp;Field Reimbursement Managers&nbsp;and&nbsp;Nurse Case Managers&nbsp;&nbsp; Oversee the comprehensive field-based Nurse Case Management and Access Program&nbsp;for Dyne&nbsp; Foster a coaching culture that enables deeper connection with patients, caregivers, and HCPs.&nbsp; Set the tone and culture of the team, role model Dyne patient and caregiver, and HCP engagement expectations&nbsp; Cultivate a&nbsp;“One Dyne”&nbsp;mindset that prioritizes transparency,&nbsp;shared&nbsp;ownership&nbsp;and accountability,&nbsp;where the success of&nbsp;cross-collaborative field team is central to the success of&nbsp;the individual team.&nbsp; Develop and execute a national plan that is strategically aligned with the overall US Market Access and Patient Services objectives&nbsp;and enables execution of regional business goals in partnership with other Field Leadership.&nbsp; Manage hiring, onboarding, communication, performance,&nbsp;training&nbsp;and professional development across the team.&nbsp; Collaborate with internal cross functional partners and external partners (specialty infusion providers, patient support services program) to ensure ongoing support to patients, and their families / caregivers and HCPs.&nbsp; Develop and&nbsp;maintain&nbsp;strong relationships with HCPs involved with DYNE-251 therapy.&nbsp; Ensure team&nbsp;expertise&nbsp;in insurance coverage, reimbursement, PA processes, and payer landscapes.&nbsp; Drive problem-solving to resolve access barriers for patients, caregivers, and HCPs.&nbsp; Deliver execution plans and manage KPIs supporting post-prescribing performance.&nbsp; Identify&nbsp;and mitigate risks while ensuring compliance with Dyne policies.&nbsp; Maintain&nbsp;deep&nbsp;understanding of DMD treatment journeys and adjust tactics accordingly.&nbsp; Maintain knowledge of rare disease payer policies, including Medicaid.&nbsp; Education, Knowledge &amp; Skill Requirements&nbsp;&nbsp; The successful candidate should be a dynamic&nbsp;self-starter&nbsp;with proven abilities as a biopharma commercial leader. S/he will have led successful product launches,&nbsp;have a patient focused mindset and&nbsp;a strong reputation&nbsp;for excellent cross-functional collaboration and&nbsp;possess&nbsp;the following:&nbsp; 15+ years of experience in the Biotech, Pharmaceutical or Healthcare industry&nbsp; 10+ years of field reimbursement and/or nurse case management experience in the Pharmaceutical or Healthcare industries, including rare disease experience and launch experience&nbsp;with&nbsp;HCP-administered therapies, and ideally with home infusion therapies&nbsp; 5+ years leading and coaching teams of Field Reimbursement Managers and/or Field Nurse Case Managers&nbsp; Has prior experience supporting patients and their caregivers (e.g., nursing, counselor, social work, other allied health positions background) – ideally has worked with pediatric populations and/or within an environment that supported patient in-home visits&nbsp;&nbsp; Has prior experience supporting coverage and reimbursement processes for HCP-administered, rare disease products&nbsp;&nbsp; Can&nbsp;demonstrate&nbsp;a deep understanding of payer policies and processes for obtaining coverage / pre-certification and reimbursement for HCP-administered therapies,&nbsp;in particular with&nbsp;State Medicaid FFS and Managed Medicaid policies and processes&nbsp; Experience working with IDNs, academic medical centers and large health systems&nbsp; Empathetic, friendly, and relatable, with effective communication skills&nbsp; Comfortable speaking with patients/families, HCPs&nbsp; Willingness to work as leader of and part of an overall commercial team in a demanding environment&nbsp; Embraces continuous learning/seeks knowledge&nbsp;&nbsp; Travel is&nbsp;required.&nbsp; It is expected that the leader will be in field&nbsp;working with the team and meeting stakeholders on a regular basis.&nbsp; MA Pay Range$250,000&mdash;$300,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Dyne Patient Access and Education

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary The Corporate Account Director is a senior commercial leader responsible for shaping and executing Dyne’s U.S. market access strategy across Medicaid (fee‑for‑service and managed care), select Medicare segments, and key federal payer channels. This role serves as the enterprise lead for assigned public payer accounts, driving coverage, reimbursement, formulary positioning, and innovative access solutions supporting Dyne’s rare and specialty therapeutic portfolio, including launch‑stage products. The CAD must excel at strategic navigation of complex state and federal programs, thrive in fast‑paced, growth‑oriented environments, and build trusted, high‑impact relationships with diverse payer stakeholders. This is a field-based role. &nbsp;Key Responsibilities Public Payer Strategy &amp; Policy Develop and execute Medicaid and public payer access strategies aligned with regulatory, budgetary, and policy requirements. Navigate Medicaid Drug Rebate Program requirements and state-specific access pathways. Serve as the internal subject-matter expert on public payer coverage, reimbursement, and health equity considerations. Government Account Management Lead engagement with state Medicaid agencies, Medicaid MCOs, and federal payer organizations (e.g., VA, DoD, TRICARE, Indian Health Services). Support P&amp;T committee reviews, coverage determinations, and utilization management discussions. Educate public payer stakeholders on disease state, clinical value, and anticipated budget impact in preparation for and through launch. Develop and execute national and public payer strategies that optimize coverage, reimbursement, and formulary access across commercial, PBM, Medicaid, Medicare, and federal payer segments. Anticipate and respond to evolving payer dynamics, policy changes, benefit design trends, and specialty drug management strategies. Serve as the internal subject-matter expert on payer access, reimbursement models, channel economics, and rare/specialty disease policy. Contracting &amp; Access Solutions Partner with Contracts &amp; Pricing, Legal, and Finance to support rebate or innovative contracting approaches when appropriate. Collaborate on public payer-specific distribution, specialty pharmacy, and affordability strategies/considerations. Cross-Functional Commercial Leadership Lead and coordinate cross-functional account teams (Market Access, Sales, Medical Affairs, HEOR, Trade, Marketing, Legal, Finance, Patient Services). Translate complex clinical, economic, and health equity data into clear, compliant payer communications. Partner closely with Patient Services, Trade and Field teams to support rapid patient access. Support organizational readiness and pull-through across pre-launch and post-launch phases. Insight Generation &amp; External Influence Monitor and synthesize payer, policy, reimbursement, and competitive insights for senior leadership. Representing the organization at payer meetings, industry forums, and trade associations. Identify opportunities for strategic partnerships, policy engagement, and innovative access programs. Compliance Ensure all public payer engagements comply with applicable laws, regulations, and internal compliance policies. Qualifications Bachelor’s degree: advanced degree (MBA, MPH, MS, PharmD) preferred. 10+ years of experience in the biopharma industry, including at least 8 years in Medicaid, public payer, or managed markets roles. Strong understanding of Medicaid structures, state policy environments, reimbursement mechanics, and public payer decision‑making. Experience supporting access for specialty, rare disease, or high‑cost therapies. Deep understanding of U.S. payer systems, reimbursement pathways, specialty distribution, and Medicaid/federal payer dynamics. Excellent communication, stakeholder engagement, and cross‑functional leadership skills. Strong negotiation and strategic planning abilities with executive presence. Demonstrated success operating in launch‑stage, high‑growth, or ambiguous environments. Ability to travel domestically, including overnight travel. MA Pay Range$210,000&mdash;$252,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Corporate Account Director - Public Payer

Company Overview: Dyne Therapeutics is focused on delivering functional&nbsp;improvement&nbsp;for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals,&nbsp;families&nbsp;and communities. &nbsp;Learn more&nbsp;https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.&nbsp;&nbsp;Role Summary The Corporate Account Director (CAD) is a senior commercial leader responsible for shaping and executing Dyne’s U.S. market access strategy across priority national and regional payer accounts, PBMs, Medicaid, Medicare, and federal payer channels. This role serves as the enterprise lead for assigned accounts, driving coverage, reimbursement, formulary positioning, and innovative access solutions across Dyne’s neuromuscular portfolio. The CAD collaborates closely with Market Access, HEOR, Medical Affairs, Trade, Sales, Patient Services, Legal, and Finance to ensure rapid and equitable patient access. This is a field‑based role. Key Responsibilities Market Access &amp; Payer Strategy Develop and execute account specific payer strategies that optimize‑specific payer strategies that optimize coverage, reimbursement, and formulary access across commercial, PBM, Medicaid, Medicare, and federal payer segments. Anticipate evolving payer dynamics, benefit design changes, policy shifts, and specialty management trends. Serve as an internal subject-matter expert on access pathways, ‑matter expert on access pathways, rare‑disease reimbursement, channel economics, and payer policy. National Account Leadership &amp; Contracting Lead strategic engagement and negotiations with national and regional payers, PBMs, Medicaid MCOs, and federal payers. Secure favorable coverage policies, UM criteria, and contracting arrangements—including value-based models where appropriate‑based models where appropriate. Identify account-specific access barriers and develop compliant, specific access barriers and develop compliant, data‑driven solutions in partnership with HEOR, Medical, Policy, Trade, and Patient Services. Cross Functional‑Functional Commercial Leadership Lead cross-functional account planning and coordination across Market Access, Medical Affairs, HEOR, Trade, Commercial, Legal, and Finance. Translate payer insights into actionable recommendations for launch execution, forecasting, brand positioning, and pipeline strategy. Support organizational readiness across pre‑launch, launch, and post‑launch phases to enable rapid patient access. External Influence &amp; Insight Generation Monitor payer, policy, and competitive developments; synthesize insights for senior leadership. Represent Dyne at payer engagements, industry associations, and strategic forums. Identify opportunities for partnerships, innovative access programs, and policy engagement. &nbsp;Compliance &amp; Governance Ensure all interactions, materials, and contracting activities comply with Dyne policies, legal, regulatory, and compliance standards. Qualifications Bachelor’s degree: advanced degree such as MBA, MPH, MS, or PharmD preferred. 10+ years of experience in the biopharma industry, including at least 8 years in Market Access, National Accounts, Managed Markets, or Trade. Proven success securing access for specialty, rare‑disease, or high‑cost therapies across commercial and/or public payer segments. Deep understanding of U.S. payer systems, reimbursement pathways, specialty pharmacy distribution, and Medicaid/federal payer dynamics. Strong negotiation skills and executive presence, with the ability to influence across complex, cross‑functional organizations. Demonstrated ability to operate effectively in high‑growth, launch‑stage, or ambiguous environments. Alignment with Dyne’s values, including a patient‑centric mindset, integrity, collaboration, and accountability. Ability to travel domestically, including overnight travel. &nbsp;MA Pay Range$210,000&mdash;$252,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Corporate Account Director - Southeast Region

Corporate Account Director - Southwest Region

Corporate Account Director - Central Region

Corporate Account Director - Northeast Region

Corporate Account Director - West Region

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The Principal Engineer, Technical Development serves as a technical engineering lead and driver for strategy, conception, optimization, and implementation of innovative manufacturing technologies within the Technical Development organization. This leader blends deep engineering expertise with cross-functional influence to implement innovative manufacturing systems for bioprocess and bioconjugation at clinical and commercial scales and accelerates time to market. The role is ideal for someone who thrives at the intersection of innovation, operations, and process development strategy. This is a full-time position based in Waltham, MA with no option for remote work. Primary Responsibilities: Technical Leadership Design, optimize and implement engineering for manufacturing processes for new and existing products under current Good Manufacturing Practices (cGMP) Lead engineering technology selection, process modeling, equipment specification, and system integration and provide guidance and oversight of outsourced activities at CDMOs. Develop and validate process control strategies, including PAT, automation, and real time monitoring. Serve as the subject matter expert for engineering across manufacturing, operations, and R&amp;D. Strategic Impact Build and execute the long-term engineering roadmap for manufacturing capabilities across all relevant modalities (biologics, oligonucleotides, and bioconjugates). Identify opportunities to transition batch processes to innovative platforms, improving throughput and cost-of-goods, while preserving product quality. Partner with senior leadership to align manufacturing strategy with business goals and regulatory expectations. Cross Functional Collaboration Work closely with Quality, Supply Chain, and Manufacturing Operations to ensure seamless technology transfer and scaleup. Guide technical teams through engineering design reviews, process risk assessments, and regulatory submissions, fostering a culture of innovation and technical excellence. Operational Excellence Drive continuous improvement initiatives using Lean, Six Sigma, and advanced process analytics. Troubleshoot complex manufacturing challenges and implement robust, sustainable solutions. Ensure compliance with cGMP, safety standards, and global regulatory requirements. Education, Experience, and Skills Requirements: Bachelor’s degree in chemical or similar engineering discipline with minimum of 7 years relevant experience; advanced degree MS or PhD preferred Proven track record designing, implementing, and scaling manufacturing systems Hands-on approach for operation of and troubleshooting manufacturing skids Development and implementation of PAT technologies Experience overseeing outsourced activities at CDMOs Expertise in process modeling, control systems, automation, and PAT. Experience in Biologics Downstream Purification Process Development and/or Bioconjugation Development preferred Familiar with the concepts of Scale-Down Model Qualification (SDMQ), Process Characterization, and defining Process Control Strategy (PCS) Strong understanding of current Good Manufacturing Practices (cGMP) and regulatory frameworks (FDA, EMA, ICH) relevant to continuous manufacturing of biologics. Attention to detail, exceptional communication skills, and the ability to influence all levels of the organization. MA Pay Range$147,000&mdash;$180,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Principal Engineer, Technical Development

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The&nbsp;Program Team Leader (PTL)&nbsp;is a passionate, globally minded drug developer who brings adaptable leadership, deep strategic product development&nbsp;expertise, and a relentless commitment to delivering transformative medicines to patients. As a highly visible leader, the PTL partners closely with an experienced Program Manager and a&nbsp;cross functional&nbsp;team to shape Program strategy, define goals and priorities, and chart an integrated plan that balances a&nbsp;future&nbsp;focused&nbsp;vision of global commercial access with the pragmatic&nbsp;decision-making&nbsp;needed to advance through complex development milestones.&nbsp; This&nbsp;role&nbsp;is&nbsp;based&nbsp;in&nbsp;Waltham,&nbsp;MA&nbsp;without&nbsp;the&nbsp;possibility&nbsp;of&nbsp;being&nbsp;a&nbsp;remote&nbsp;role.&nbsp; Primary&nbsp;Responsibilities&nbsp;Include:&nbsp; Program Leadership &amp; Strategy&nbsp; Lead a&nbsp;high-performing,&nbsp;cross-functional&nbsp;Program Team by defining both the&nbsp;what&nbsp;(strategy, priorities, deliverables, and resources) and the&nbsp;how&nbsp;(a healthy, collaborative, and sustainable team environment).&nbsp; Establish, communicate, and continually evolve a robust Program strategy to deliver&nbsp;a life-changing&nbsp;medicine to patients in need.&nbsp; Ensure alignment of research, nonclinical, clinical, regulatory, CMC, and commercial strategies with the overarching Program strategy.&nbsp; Serve as the primary owner of Program recommendations across all stages of development, driving toward milestones, timelines, and&nbsp;value-creating decision points. Decision-Making &amp; Communication&nbsp; Structure,&nbsp;facilitate, and drive&nbsp;timely, high-quality cross-functional&nbsp;decision-making&nbsp;with both the Program Team and senior leadership, ensuring all critical perspectives are appropriately considered.&nbsp; Prepare and deliver&nbsp;high-impact&nbsp;materials for the Board of Directors, Scientific Advisory Board, and other key governance bodies.&nbsp; Maintain clear, open, and proactive communication with senior leadership regarding Program strategy, progress, risks, dependencies, and resource needs. Scientific &amp; External Engagement&nbsp; Stay abreast of emerging scientific and development trends in muscle diseases and oligonucleotide drug discovery and development.&nbsp; Build a visible, credible presence within the KOL and patient advocacy communities for the relevant disease areas.&nbsp; Participate in business development activities as needed, including opportunity evaluations and due diligence. Organizational Leadership&nbsp; Model and reinforce company values, especially during periods of rapid growth and change.&nbsp; Serve as a primary advocate for the Program within the broader portfolio and corporate strategic context.&nbsp; Collaborate with&nbsp;Finance and functional leaders to responsibly manage the Program budget.&nbsp; Foster a culture of scientific excellence, innovation, open communication, and continuous improvement.&nbsp; Actively coach and support team members to help them perform at their&nbsp;best, and&nbsp;identify or mitigate skill or capacity gaps within the team.&nbsp; Consider&nbsp;needs&nbsp;of&nbsp;the&nbsp;Program&nbsp;in&nbsp;context&nbsp;of&nbsp;Dyne&nbsp;corporate&nbsp;strategy&nbsp;and&nbsp;priorities,&nbsp;as primary advocate for the Program among Dyne senior leadership&nbsp; Education and Skills Requirements Experience in Phase 1-3 drug development is required; product launch/early commercialization experience a strong plus Proven and respected leader with: Advanced degree in Medical or Life Science, MD, PhD or MBA or equivalent 20 years of experience in pharmaceutical industry in leadership positions in drug development and proven track record in driving Programs through IND, early clinical, pivotal stages and approval And/or at least 12 years in pharmaceutical industry in significant development and/or commercial leadership or general management positions including working with development teams in cross-functional setting, with exceptional track record of delivering on business objectives, activity/milestones leading to filing and launching, and strong knowledge of neuromuscular diseases Experience in rare genetic diseases preferred Other key traits: Entrepreneurial team leader, able to shape and communicate the vision for an important therapeutic Program and guiding the development of the product strategy and its execution Insightful people leader supporting and coaching high-caliber functional experts to achieve their absolute best Collaborative corporate leader partnering with other senior leaders to shape and fulfil Dyne’s overall mission to develop and commercialize transformational therapeutics for people living with serious diseases Orientation towards collective achievement and team credit, combined with individual sense of responsibility and accountability for teamwork and product Adept at leading through ambiguity and provide steadiness and consistency among shifting priorities Comfortable with fast-paced and nimble organizational environment Demonstrated experience in building highly effective and motivated cross-functional teams and in guiding teams and organizations in making complex and high-stakes data-driven decisions Proven acumen for cross-functional leadership and influencing without direct authority, both among cross-functional team members and senior functional leaders Demonstrated scientific knowledge and curiosity necessary for thought partnership across all functions Proven ability to establish and maintain credible and trust-based relationships with external stakeholders (e.g., KOLs, patient advocacy groups, regulators or investors) Outstanding sense of urgency and ability to pace the team’s work to achieve milestone achievement in highly competitive landscape Excellent communication skills (verbal, written, presentation) and ability to clearly communicate complex ideas stakeholders and teams at all levels Natural focus on team dynamics and proven ability to coach and support team members to perform at their best Effective people-oriented collaboration skills in an environment with cross internal functional teams, and third-party collaborators/vendors Team player and mentor, who listens effectively and invites response and discussion Collaborator who communicates in an open, clear, complete, timely and consistent manner MA Pay Range$288,000&mdash;$350,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

VP, Program Team Leader

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary&nbsp; The Director, US Field Effectiveness &amp; Operations is a critical role within the Commercial organization, responsible for driving strategic initiatives and operational excellence to fuel business growth. This individual will build the operational infrastructure for the Key Account Manager (KAM) field force from the ground up, including field analytics and dashboards, territory sizing and alignment, targeting, and the development and execution of field force effectiveness programs. This role requires strong cross-functional collaboration across Sales, Marketing, Market Access, Advanced Analytics, Patient Services, Finance, IT, and US Commercial Leadership to ensure launch readiness. The Director will champion innovation and operational efficiency, building scalable processes that enhance collaboration and field productivity with a patient-first mindset. This is a remote-based, individual contributor role requiring strong communication, self-initiative, and consultative engagement skills. Primary Responsibilities Field Effectiveness Build field reporting and analytics capabilities from the ground up to support KAM performance and decision-making. Partner with field leadership to define KPIs and develop analytics and dashboards to track performance and impact. Design and lead a Quarterly Business Review (QBR) process to assess commercial effectiveness and outcomes. Spend time in the field to understand Dyne’s operating model and translate insights into practical, field-ready solutions. Own KAM performance analytics and execution in support of incentive compensation programs. Collaborate with the KAM team to design and implement an account planning tool. Develop regional and account-level performance dashboards. Recommend and drive enhancements to BI and CRM tools to improve KAM effectiveness. Field Operations Serve as the primary point of contact for the VP, Customer Experience, KAM leadership, and the KAM field team. Lead field force sizing and structural planning for upcoming launches and ongoing strategic reviews. Establish and maintain territory alignment and adjustment processes. Lead account and HCP targeting strategy and analytics in partnership with the Data and Advanced Analytics teams. Optimize field enablement tools, materials, and processes to maximize field productivity. Education and Skills Requirements Bachelor’s degree with 10+ years of experience in biotech, pharma, or life sciences. 5+ years of experience in field sales, sales leadership, field operations, or consulting roles with deep field operations exposure. Proven track record supporting or launching rare disease therapies, preferably in neuromuscular, neurodegenerative, or neurodevelopmental indications. Demonstrated ability to build and scale commercial infrastructure, including vendor management. Strategic thinker with strong business acumen and a results-oriented mindset. Proficiency with commercial technology platforms and data, including CRM, BI tools, Snowflake, Boomi, SP/SIP, and HUB data. Excellent written and verbal communication skills, with experience presenting to senior leadership. Strong problem-solving skills and ability to operate effectively in a fast-paced, evolving environment. Travel may be required for this role MA Pay Range$188,000&mdash;$230,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, US Field Effectiveness & Operations

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The Associate Director, Trial&nbsp;Master&nbsp;File (TMF) Lead&nbsp;is responsible for&nbsp;developing and driving the global TMF strategy,&nbsp;establishing&nbsp;and maintaining robust governance frameworks, and ensuring end&nbsp;to&nbsp;end oversight of the Trial Master File across the clinical portfolio. This role serves as the enterprise owner of TMF processes, quality standards, and inspection readiness, ensuring that TMF operations meet regulatory requirements, support high&nbsp;quality clinical execution, and&nbsp;operate&nbsp;efficiently at scale.&nbsp;This&nbsp;role&nbsp;partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance&nbsp;&nbsp;Primary Responsibilities&nbsp;Include:&nbsp; TMF Strategy &amp; Leadership:&nbsp; Define and own the company’s TMF strategy,&nbsp;including&nbsp;innovation opportunities and continuous improvement initiatives&nbsp; Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals&nbsp; Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends&nbsp; Represent TMF leadership in cross&nbsp;functional forums, governance committees, and senior&nbsp;level operational discussions&nbsp; Governance &amp; Process Ownership:&nbsp; Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards&nbsp; Oversee TMF lifecycle management—from planning and setup through&nbsp;closeout&nbsp;and archival&nbsp; Define TMF roles, responsibilities, and RACI structures across internal teams and vendors&nbsp; Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues&nbsp; Ensure&nbsp;timely&nbsp;collection, review, and management of TMF documents from&nbsp;clinical&nbsp;study teams and external partners&nbsp;&nbsp; TMF Oversight &amp; Compliance:&nbsp; Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs)&nbsp; Ensure TMFs across the portfolio remain inspection&nbsp;ready&nbsp;&nbsp; Lead TMF&nbsp;related preparation for audits, inspections, and regulatory submissions, ensuring all documentation is complete and&nbsp;accurate&nbsp;&nbsp; Analyze TMF metrics and trends to proactively&nbsp;identify&nbsp;risks, gaps, and improvement opportunities&nbsp;to implement proactively&nbsp; Vendor &amp; Technology Management:&nbsp; Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements&nbsp; Partner with IT and business stakeholders to&nbsp;optimize&nbsp;the eTMF system, workflows, and integrations&nbsp; Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF&nbsp; Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices&nbsp;&nbsp; Cross&nbsp;Functional Partnership &amp; Support:&nbsp; Collaborate with&nbsp;cross-functional study teams&nbsp;to guide TMF planning, milestones, and document management expectations&nbsp; Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements&nbsp; Advise&nbsp;leadership on TMF health and organizational readiness for key regulatory events&nbsp; Education and Skills Requirements:&nbsp; Bachelor’s degree in life sciences or related field; advanced degree preferred&nbsp; 8+ years of experience in clinical operations, document management, or related&nbsp;GxP&nbsp;environment, with significant TMF&nbsp;expertise&nbsp; Strong knowledge of&nbsp;ICHGCP, TMF Reference Model, and global regulatory expectations&nbsp; Proven experience developing TMF strategy, governance frameworks, or enterprise&nbsp;level processes&nbsp; Ability to lead cross-functionally without authority&nbsp;Demonstrated leadership in managing TMF operations or oversight at a portfolio level&nbsp; Experience working with eTMF systems and CRO/vendor oversight&nbsp; Excellent communication, influencing, and stakeholder&nbsp;management skills&nbsp; MA Pay Range$155,000&mdash;$190,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, Trial Master File Lead

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The Senior Manager, Statistical Programming&nbsp;serves&nbsp;as the statistical programming lead for a defined number of clinical studies, with accountability for all study-level statistical programming activities conducted in-house and/or through vendor oversight. This&nbsp;role&nbsp;is&nbsp;the primary point of contact for statistical programming and data standards for assigned studies, providing technical leadership and consultation to cross-functional program teams. The Senior Manager&nbsp;also supports&nbsp;the planning and resourcing of statistical programming activities to ensure&nbsp;timely&nbsp;and high-quality delivery across the Dyne clinical portfolio. This position&nbsp;contributes to departmental strategy, as well as the development and continuous improvement of programming procedures, training, and standards.&nbsp; This is a full-time position based&nbsp;in Waltham, MA.&nbsp;&nbsp; &nbsp;Primary Responsibilities&nbsp;Include:&nbsp; Lead&nbsp;statistical programming for&nbsp;assigned clinical studies, with end-to-end accountability for study-level programming deliverables, quality, timelines, and compliance with regulatory requirements and internal standards&nbsp; Oversee and coordinate FSP vendor-based statistical programming resources, including task assignments, progress tracking, issue escalation, and quality oversight&nbsp; Plan, manage, and&nbsp;monitor&nbsp;project timelines and deliverables across assigned studies to ensure on-time and high-quality execution in alignment with study milestones&nbsp;and escalate risks as appropriate&nbsp;&nbsp; Collaborate closely with biostatisticians, data managers, and cross-functional teams to define and execute effective programming activities and study-specific requirements&nbsp; Develop,&nbsp;validate, and&nbsp;maintain&nbsp;analysis datasets (CDISC-compliant SDTM and&nbsp;ADaM), as well as tables, listings, and figures (TLFs),&nbsp;in accordance with&nbsp;regulatory guidelines and internal standards&nbsp; Review and provide input on Statistical Analysis Plans (SAPs) to ensure programming assumptions, derivations, and outputs are clearly defined and executable&nbsp; Perform or oversee complex statistical programming and analyses using SAS to support clinical trial analyses and data interpretation&nbsp; Provide statistical programming&nbsp;expertise&nbsp;to oversee and/or perform activities supporting regulatory submissions (e.g., FDA, EMA), including the preparation of electronic submission components (eCTD), Define.xml, and reviewer guides&nbsp; Stay current with industry trends, best practices, and emerging technologies in statistical programming, data standards, and regulatory expectations&nbsp; &nbsp; Education, Experience,&nbsp;and Skills Requirements:&nbsp; Bachelor's or advanced degree in statistics, biostatistics, computer science, or a related field&nbsp; 7+&nbsp;years of experience in statistical programming within the pharmaceutical or biotech industry&nbsp; Proficiency&nbsp;in SAS is essential; experience with R is preferrable&nbsp; Strong knowledge of CDISC standards (SDTM,&nbsp;ADaM) and regulatory requirements for clinical trials&nbsp; Demonstrated leadership and project management skills, including the ability to collaborate with cross-functional teams&nbsp; Excellent&nbsp;written and verbal&nbsp;communication and interpersonal skills&nbsp; Detail-oriented with a commitment to data accuracy and quality&nbsp; Ability to adapt to changing priorities and manage multiple projects simultaneously&nbsp; MA Pay Range$143,000&mdash;$175,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Manager, Statistical Programming

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The Director, Business &amp; Operations – US Affiliate will serve as a key strategic and operational partner to the SVP, Head of US Affiliate, supporting the effectiveness, execution, and scalability of the US Affiliate organization. This role will provide operational leadership and continuity across the function, enabling the SVP and US Affiliate Leadership Team to remain focused on the highest‑impact priorities as Dyne builds and grows its US presence. The Director will be responsible for business operations across the US Affiliate, including budget ownership and financial planning, vendor and contract management, operating rhythm and governance, and the execution of function‑wide initiatives. Acting as a connective hub across Commercial, Medical, Finance, Legal, HR, and other G&amp;A partners, this leader will translate strategic priorities into well‑structured plans, drive execution, and ensure visibility into progress, risks, and resource needs. The ideal candidate is highly organized, proactive, and comfortable operating in a fast‑paced, evolving environment. They bring strong judgment, executive presence, and the ability to influence without authority, paired with a hands‑on approach to getting work done. This role is based in Waltham, MA. Key Responsibilities Strategic &amp; Operational Partnership Serve as a trusted thought partner to the SVP, Head of US Affiliate, helping translate affiliate strategy and priorities into clear, actionable, and measurable operating plans. Support the US Affiliate Leadership Team with structured problem solving, prioritization, and follow‑through across key initiatives. Anticipate organizational needs and proactively bring recommendations, options, and solutions to leadership. Business Operations &amp; Operating Rhythm Establish and manage the operating rhythm for the US Affiliate, including leadership meetings, business reviews, planning cycles, and governance forums. Drive clarity on goals, ownership, timelines, and success metrics across affiliate initiatives. Develop and maintain dashboards and tracking tools that provide transparency into performance, risks, dependencies, and decision points. Budget, Financial Planning &amp; Resource Management Support development and management of the US Affiliate budget in close partnership with Finance, including annual planning, forecasting, tracking, and variance management. Support headcount planning, resource allocation, and investment prioritization to ensure alignment with affiliate and enterprise objectives. Prepare budget materials, analyses, and recommendations for affiliate leadership and enterprise review forums. Vendor, Contract &amp; External Partner Management Oversee vendor strategy and management for the US Affiliate, including agency partners, consultants, and other external service providers. Partner with Legal, Finance, and Procurement to manage contracts, statements of work, renewals, and compliance. Ensure vendors are delivering against scope, timelines, and value expectations. Cross‑Functional &amp; Enterprise Initiatives Lead and coordinate high‑priority, function‑wide and cross‑functional initiatives impacting the US Affiliate. Act as a central point of integration between the US Affiliate and partner functions to ensure alignment and execution. Track initiative progress, identify risks, and escalate issues with proposed solutions. Leadership Enablement &amp; Execution Drive coordination across HQ and field‑based roles spanning Commercial, Medical, and partner functions to maintain momentum and alignment on priority initiatives. Design and manage the US Affiliate “Cadence of the Business,” including Leadership Team meetings, offsites, business reviews, and short‑ and long‑term planning cycles. Serve as a leader for high‑priority initiatives that do not have a natural functional home (e.g., ways of working, launch KPI management, executive reporting). Support change management and organization‑wide communication for new processes, initiatives, and ways of working. Qualifications &amp; Experience Bachelor’s degree required; advanced degree (MBA or equivalent) preferred. 10+ years of progressive experience in commercialization strategy, commercial operations, program management, or related roles within biotechnology or pharmaceuticals, or relevant experience from a biotech or life sciences consulting firm focused on commercialization or commercial planning. Experience supporting senior leaders and leadership teams in high‑growth or launch‑stage environments. Demonstrated experience with budget management, financial planning, and vendor/contract oversight. Strong cross‑functional leadership skills with the ability to influence without formal authority. Exceptional written and verbal communication skills; able to synthesize complexity into clear, executive‑ready thinking. Highly organized, detail‑oriented, and comfortable managing multiple priorities simultaneously. High integrity and discretion in handling sensitive and confidential information. MA Pay Range$188,000&mdash;$240,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Business & Operations – US Affiliate

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: Dyne Therapeutics is seeking an experienced Data, Integration and AI Engineering lead to direct, manage, and optimize the strategy, architecture, and delivery of the company’s enterprise data, integration, and AI technology ecosystem. The ideal candidate will have deep expertise in integration architecture, hands-on experience with the stand-up and operation of Boomi and Snowflake, and a strong background in biotech or pharmaceutical environments where compliance and data integrity are paramount. This role is accountable for: Enterprise data architecture Integration architecture and platform strategy Applicable Cloud-native AWS architecture Dyne’s Snowflake data platform Boomi (or equivalent) integration platform Design and build-out of an AI Technology Foundry The Director will establish scalable, compliant, and secure architectures that support Dyne’s clinical, commercial, research, and corporate functions, while enabling advanced analytics and AI-driven capabilities. This leader will work cross-functionally with our Managed Service Provider, Omnichannel Digital Marketing Team, IT, Clinical, Commercial Operations, Finance, and external partners in a highly regulated biotech environment. This role is based in Waltham, MA.&nbsp;&nbsp;Primary Responsibilities Include:&nbsp; Enterprise Data &amp; Integration Architecture Leadership Own and define enterprise data architecture and integration architecture standards across Dyne. Serve as the architectural authority for system-to-system integrations, data flows, APIs, and event-based architectures. Design scalable patterns for integrating internal platforms and external partners, including: 3PLs Specialty pharmacies CROs Data aggregators Commercial, clinical, and regulatory systems Ensure architectural alignment across ERP, CRM, HRIS, Channel, and analytics platforms. Establish architectural principles that support “build once, scale across products and geographies.” Integration Ownership &amp; Development: Provide executive oversight of the integration approach, tools and platforms Serve as the primary owner of the Boomi integration platform and Snowflake data lake environment. Design, build, and deploy integrations between internal systems and external partners (e.g., 3PL, specialty pharmacy, CROs, data aggregators). Develop and maintain integration workflows, connectors, APIs, and ETL/ELT processes for data ingestion and transformation. Ensure integrations are secure, scalable, and compliant with industry standards and regulatory requirements (e.g., GxP). Support the onboarding of the company’s data aggregator Platform Management: Configure, optimize, and maintain Boomi and Snowflake environments. Manage user access, roles, and permissions for integration and data platforms. Implement best practices for security, performance, and scalability. Monitor integration and system performance, troubleshoot issues, and implement error handling, logging, and alerting. Lead the end-to-end AWS architecture supporting data integration and transformation, Snowflake integration, Analytics and BI, AI/ML workload management Data Modeling &amp; Analytics Enablement: Design and build robust data models and schemas to support business functions (Commercial, Clinical, R\&amp;D). Layer on visualization tools (Power BI, Tableau) for reporting and dashboards. Support&nbsp;BI and dashboarding initiatives&nbsp;and provide guidance on data access. Collaboration &amp; Documentation: Work closely with IT, Commercial, Clinical, Finance, and other areas of the business as well as external vendors to understand integration requirements. Document integration architecture, processes, and best practices. Provide ongoing support, enhancements, and documentation for existing integrations and platforms. AI Technology Foundry – Strategy and Build Lead the design and build-out of the Dyne AI technology Foundry, including Advanced analytics Machine learning Generative AI use case implementation Leadership, Collaboration &amp; Governance Act as a senior leader in the IT department and beyond; advising across the organization Provide mentorship and technical leadership to all those in IT Support vendor selection (e.g., MSP), contract evaluation and platform strategy Education and Skills Requirements: Bachelors in Computer Science required, Master’s degree preferred 10+ years of experience in integration engineering, data engineering, or related roles Hands-on experience with Boomi (design, deployment, administration) and Snowflake (configuration, optimization, data modeling) Strong understanding of APIs, web services (REST/SOAP), data formats (JSON, XML), and SQL Experience integrating ERP, CRM, HRIS, and other data platforms Proficiency with Power BI and Tableau for data visualization Experience in biotech or pharmaceutical environments, including integrations with 3PLs, specialty pharmacies, CROs, and clinical systems Understanding of compliance requirements (e.g., GxP, HIPAA) and data governance in life sciences Ability to work independently and manage multiple priorities in a fast-paced environment Strong communication and collaboration skills across technical and business teams Familiarity with NetSuite, Veeva, ADP, and Snowflake integrations Knowledge of cloud platforms such as AWS and security best practices Experience with clinical trial data, commercial sales data, and regulatory reporting Snowflake SnowPro certification preferred Boomi Developer certification preferred &nbsp;MA Pay Range$188,000&mdash;$244,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Director, Data, Integration & AI Engineering

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The&nbsp;Senior&nbsp;Director, Medical&nbsp;Information&nbsp;is responsible for&nbsp;establishing&nbsp;and leading the medical information function to ensure&nbsp;timely,&nbsp;accurate, balanced, and compliant scientific responses to unsolicited inquiries from healthcare professionals. This role plays a critical part in supporting the safe and&nbsp;appropriate use&nbsp;of the company’s products by delivering high-quality medical information and enabling scientific exchange. The&nbsp;person in this role&nbsp;has strong scientific&nbsp;expertise, experience in regulated environments, and the ability to build scalable medical information processes in a biotech setting.&nbsp; This position is based in Waltham, MA, with the option to work remotely.&nbsp;&nbsp;Primary Responsibilities&nbsp;Include:&nbsp; Establish and lead the medical information function, including strategy, processes, and execution&nbsp; Establish scalable medical information infrastructure, including inquiry intake, documentation, and response workflows&nbsp; Oversee&nbsp;the implementation&nbsp;and training&nbsp;of&nbsp;the medical inquiry intake portal and call center vendors and manage&nbsp;relationships&nbsp;going forward&nbsp; Develop high-quality medical information response documents (standard response letters, FAQs, backgrounders)&nbsp;and&nbsp;maintain&nbsp;medical information content aligned with product labeling, clinical data, and evolving scientific evidence&nbsp; Lead and oversee&nbsp;Medical, Legal, and Regulatory (MLR)&nbsp;review&nbsp;&nbsp; Ensure responses are scientifically&nbsp;accurate, balanced, up-to-date, and compliant with regulation&nbsp; Ensure&nbsp;appropriate escalation&nbsp;and coordination of safety, quality, and off-label inquiries&nbsp; Analyze inquiry trends to&nbsp;identify&nbsp;knowledge gaps, unmet medical needs, and opportunities to inform medical strategy&nbsp; Monitor metrics and quality indicators to ensure continuous improvement and compliance&nbsp; Education and Skills Requirements:&nbsp; Doctorate degree (MD, PhD, PharmD) with&nbsp;15+&nbsp;years of experience&nbsp;in&nbsp;medical information or medical affairs in rare diseases, neuromuscular diseases, or a related field&nbsp; Experience&nbsp;establishing&nbsp;or leading a medical information function is strongly preferred&nbsp; Strong understanding of regulatory, compliance, and pharmacovigilance requirements&nbsp; Excellent scientific writing and verbal communication skills&nbsp; Strong organizational and process-building capabilities&nbsp; High attention to detail and commitment to compliance and scientific integrity&nbsp; Ability to work effectively in a matrixed, fast-paced biotech environment&nbsp; Strong judgment in handling complex or sensitive inquiries&nbsp; MA Pay Range$230,000&mdash;$285,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Medical Information

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The&nbsp;Senior&nbsp;Director,&nbsp;Program Management&nbsp;(PM)&nbsp;is&nbsp;a&nbsp;critical role within the cross-functional development team&nbsp;responsible for&nbsp;facilitating&nbsp;and&nbsp;driving execution across the wide spectrum of activities&nbsp;required&nbsp;for successful development of one or more molecules. &nbsp;The&nbsp;PM&nbsp;partners&nbsp;closely&nbsp;with&nbsp;the&nbsp;Program Team Leader (PTL) and&nbsp;functional subject matter experts to ensure that plans are in place with&nbsp;appropriate detail&nbsp;and risk awareness&nbsp;to&nbsp;assure&nbsp;successful achievement of the goals of the development team.&nbsp;&nbsp;The&nbsp;PM&nbsp;ensures integration&nbsp;of&nbsp;these&nbsp;detailed functional plans&nbsp;into a holistic,&nbsp;cohesive,&nbsp;and comprehensive&nbsp;program plan that achieves the strategic goals of the&nbsp;development program. &nbsp;Given the inherent uncertainty associated with drug development in rare disorders,&nbsp;the PM&nbsp;maintains&nbsp;an agile mindset&nbsp;in order to&nbsp;effectively incorporate and react to&nbsp;emerging data and&nbsp;course correct&nbsp;as&nbsp;conditions dictate.&nbsp;&nbsp;Working in&nbsp;close&nbsp;partnership with&nbsp;the&nbsp;PTL, the PM&nbsp;effectively frames and&nbsp;facilitates&nbsp;discussions&nbsp;with&nbsp;team members and external experts&nbsp;to&nbsp;elicit&nbsp;clear&nbsp;recommendations and decisions&nbsp;by fully engaging with team members to consider multiple options with&nbsp;a focus on&nbsp;impact on quality, time,&nbsp;and cost. &nbsp;Their&nbsp;influence&nbsp;and engagement skills allow them to&nbsp;work with&nbsp;a highly motivated team and manage stakeholders&nbsp;at all levels of the company.&nbsp;&nbsp; This role is based in Waltham, MA without the possibility of being a remote role.&nbsp;&nbsp; Primary Responsibilities&nbsp;Include:&nbsp; Lead&nbsp;the operations of&nbsp;one or more&nbsp;high performing cross-functional teams, with focus on both the “what”,&nbsp;such as priorities,&nbsp;goal achievement, and resources, and the “how” of&nbsp;maintaining&nbsp;a&nbsp;challenging, collaborative, and sustainable team environment&nbsp; Partner with the PTL to&nbsp;identify&nbsp;short, medium, and long-term team priorities&nbsp;and propose path to address&nbsp; Drive&nbsp;execution of&nbsp;the established&nbsp;and&nbsp;aligned Program vision and strategy for bringing a life-changing medicine to patients in need&nbsp; Facilitate&nbsp;creation&nbsp;&amp; maintenance of core program strategy documents including&nbsp;Target&nbsp;Product&nbsp;Profile&nbsp;(TPP), Clinical Development Plan, Regulatory Strategy, and Supply Strategy&nbsp;in collaboration with cross-functional representatives&nbsp;&nbsp; Ensure&nbsp;that non-clinical, clinical, regulatory, and commercialization&nbsp;strategies and plans are aligned with the TPP and the overall Program Strategy&nbsp; Inspire development of an efficient plan to&nbsp;achieve development&nbsp;and commercialization&nbsp;strategy,&nbsp;optimizing&nbsp;for quality,&nbsp;speed&nbsp;and cost&nbsp; Ensure that program decisions are made in&nbsp;a timely,&nbsp;clear&nbsp;and efficient manner through interactions with the PTL, Program Team members, governance&nbsp;forums&nbsp;and other key stakeholders&nbsp; Accountable for&nbsp;creation and maintenance of&nbsp;detailed&nbsp;cross-functional&nbsp;plans and effective visual summaries thereof&nbsp;to&nbsp;instill&nbsp;awareness,&nbsp;build&nbsp;accountability and&nbsp;facilitate&nbsp;achievement&nbsp;&nbsp; Maintain clear and open communication with&nbsp;Program&nbsp;Team,&nbsp;Dyne Senior Leadership,&nbsp;and other stakeholders&nbsp;regarding&nbsp;program status, priorities,&nbsp;risks&nbsp;and needs, and&nbsp;facilitate&nbsp;appropriate strategic&nbsp;decision-making&nbsp; Partner with Head of Program Management to evolve Program Management discipline to meet needs of a growing organization that intends to launch a portfolio of disease products&nbsp; Keep abreast of emerging developments&nbsp;regarding&nbsp;research and development in the fields of muscle diseases and oligonucleotide drug discovery and development&nbsp; Foster a culture of collaboration, innovation, discovery, and&nbsp;cutting-edge&nbsp;research culture focused on scientific excellence, open communication, and continual improvement&nbsp; Education and Skills&nbsp;Requirements:&nbsp; Proven and respected team&nbsp;member&nbsp;with:&nbsp;&nbsp;&nbsp; Bachelor’s degree in science or related field;&nbsp;Advanced&nbsp;degree in a scientific discipline or MBA&nbsp;preferred&nbsp; 15+&nbsp;years of&nbsp;relevant&nbsp;experience in&nbsp;biotech/pharmaceutical industry in positions&nbsp;of increasing responsibility&nbsp;in drug development&nbsp;&nbsp; Experience with late-stage clinical development and commercial stage&nbsp;programs&nbsp;required&nbsp; Experience with neuromuscular diseases a plus&nbsp; Exceptional&nbsp;communication skills (verbal, written, presentation) and ability to communicate with across a broad group of&nbsp;stakeholders and teams&nbsp; Proficient with&nbsp;Microsoft Office 365&nbsp;applications,&nbsp;Smartsheet and other PM management workspace collaboration tools&nbsp; Expert at&nbsp;cross-functional&nbsp;teamwork&nbsp;and influencing without direct authority&nbsp; Demonstrated experience in&nbsp;working with&nbsp;highly effective teams and guiding teams and organizations in making complex and high-stakes data-driven decisions&nbsp; Passionate about developing and commercializing life-transforming therapies for patients with severe and life-threatening diseases&nbsp;&nbsp; Adept at operating in cross-functional matrix teams, developing effective relationships based on mutual trust and effective communication and thrives in a fast-paced, patient-focused environment&nbsp; Proven ability to&nbsp;establish&nbsp;and maintain credible and trust-based relationships&nbsp;&nbsp; Outstanding sense of urgency and ability to&nbsp;help&nbsp;pace&nbsp;the team’s&nbsp;work&nbsp;in highly competitive environment&nbsp; Orientation towards collective achievement and team credit, combined with individual sense of responsibility and accountability for teamwork and product&nbsp; Comfort with ambiguity and ability to provide steadiness and consistency in environment of shifting priorities&nbsp; Ability to lead&nbsp;without authority through&nbsp;complex&nbsp;and ambitious&nbsp;projects in a cross-functional team environment and high-pressure circumstances&nbsp; Comfortable in a results-driven, highly accountable environment where you can make a clear impact&nbsp; Team player who listens effectively and invites response and discussion&nbsp;&nbsp; A collaborator who communicates in an open, clear, complete,&nbsp;timely&nbsp;and consistent manner MA Pay Range$233,000&mdash;$285,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Director, Program Management

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The Associate Director, Patient Advocacy &amp; Operations works as part of the Corporate &amp; Patient Affairs (C&amp;PA) team with two key areas of focus: 1) Cultivating and supporting strategic partnerships with patient advocacy organizations and 2) day-to-day management of key Patient Advocacy and Corporate Affairs operations. Reporting to the VP, Patient Advocacy, this role is highly integrated with internal cross-functional teams and partners with external organizations. This role is based in Waltham, MA and does not offer a remote option.&nbsp; Primary Responsibilities:&nbsp; In collaboration with the VP of Patient Advocacy, partner closely with advocacy leaders and the broader patient community to advance key initiatives, including but not limited to: Executing the patient advocacy strategy in alignment with corporate objectives Fostering strong, strategic relationships with patient leaders, caregivers, and advocacy organizations to inform company programs and priorities. Leading the planning and management of Patient Community Advisory Panels/Boards. Conducting one-on-one engagements with patient advocacy leaders to identify‑ needs, insights, and opportunities for collaboration. Supporting clinical trial awareness and recruitment efforts through patient engagement and community focused‑ initiatives. Collaborating with Medical Affairs, Marketing, Market Access/Patient Services, and Corporate Affairs to integrate the patient voice into R&amp;D, clinical trial design, and commercialization efforts. Representing Dyne at patient advocacy events, conferences, and advisory boards. Collecting, synthesizing, and sharing patient community insights across functional teams. Identifying and coordinating community participants for Dyne-led events (internal and external). Partner with the VP of Patient Advocacy to plan and execute conference and patient advocacy organization (PAO) engagement activities: Supporting Dyne’s presence at patient advocacy and select scientific/medical conferences including event planning, session development, patient-facing materials, symposia, presentations, and on-site event execution. Staffing events; willingness to travel approximately 20%. Serve as the operational lead for the Patient Advocacy Grants, Sponsorships &amp; Donations committee, including budget oversight and end-to-end management of the submission process, such as coordinating with requestors, ensuring proper documentation, and overseeing contracting and payment workflows. Support the planning and execution of enterprise-wide events (e.g., advocacy walks) that bring patient community voices into the organization, serving as a Patient Advocacy representative on cross functional teams and supporting coordination tasks when needed. to support the delivery of high-quality experiences. Manage and own patient engagement–related contracting, ensuring compliance and timely execution. Lead operational processes for advancing patient advocacy materials through Medical Legal Review (MLR), ensuring accuracy, alignment, and compliance. Education and Skills Requirements: Bachelor’s degree in a relevant field required (social work, genetic counseling, nursing, public health preferred).&nbsp; 6+ years of experience in patient advocacy in the biotech/pharmaceutical industry, preferably within a clinical stage biotechnology company. Proven experience developing and sustaining partnerships with patient advocacy organizations and community leaders. Deep understanding of rare diseases and the unique needs of rare disease communities. Strong understanding of the Patient-Focused Drug Development (PFDD). Exceptional communication, diplomacy, and cross-functional collaboration skills. Experience managing budgets, teams, and compliance sensitive partnerships within a regulated environment. Proven experience partnering with clinical teams on trial awareness and recruitment efforts. Broad knowledge of the biopharma landscape and a solid working understanding of the drug development process. Strong interpersonal skills with the ability to influence without authority and work effectively across diverse functions and personalities. Compassionate, patient centered mindset, and a high degree of personal integrity. Ability to manage multiple simultaneous projects, navigate ambiguity, and thrive in a fast paced, dynamic environment. Experience with Patient Advocacy sponsorship contracting processes. Proven operations experience and excellent project, vendor, and budget management capabilities with a demonstrated ability to deliver results. Strong organizational skills and attention to detail. Bilingual fluency in Spanish is a plus. Overnight travel will be required; up to 20%. &nbsp; &nbsp; &nbsp;MA Pay Range$155,000&mdash;$200,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Associate Director, Patient Advocacy and Operations

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The Medical Science Liaison&nbsp;(MSL)&nbsp;is an&nbsp;experienced field medical expert who plays a strategic role&nbsp;on&nbsp;the field medical team with depth and breadth of business acumen, therapeutic knowledge and serves as an informal leader on the team.&nbsp;The person in this role&nbsp;is&nbsp;a customer&nbsp;facing,&nbsp;field-based extension of our Medical Affairs team.&nbsp;The MSL’s key&nbsp;objective&nbsp;is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes.&nbsp;This individual serves&nbsp;as a key scientific resource, engaging with healthcare professionals (HCPs), key opinion leaders (KOLs), and other stakeholders to provide scientific and clinical support for our portfolio.&nbsp;&nbsp; This is a field-based role. Primary Responsibilities&nbsp;Include:&nbsp; Builds awareness of the company within the medical community and develops strategic KOL/territory engagement plans aligned with the medical strategy&nbsp;&nbsp; Supports clinical research (investigator-initiated and company-sponsored), speaker development, and training as needed&nbsp;&nbsp; Demonstrates thorough knowledge of the company, its investigational products, and current medical research&nbsp;&nbsp; Maximizes attendance at national and regional conferences to gather insights, assess the competitive landscape, and strengthen relationships&nbsp;&nbsp; Collaborates cross-functionally (clinical, regulatory, market access) to advance business and scientific goals&nbsp; Develops&nbsp;and&nbsp;executes&nbsp;regional medical strategies in alignment with company goals&nbsp; Leads&nbsp;KOL engagement strategies and&nbsp;identifying&nbsp;new scientific leaders&nbsp; Demonstrates business acumen within therapeutic area and understands broader organization and competitive landscape&nbsp; Leads identification and mapping of key KOLs within the therapeutic area, driving engagement strategies&nbsp; Provides strategic leadership within the MSL team as a peer leader, motivator, and problem solver&nbsp; Manages top-tier KOL relationships, synthesizes high-level medical insights, and informs company&nbsp;medical&nbsp;strategies&nbsp; Mentors junior MSLs and contributes to team strategy development&nbsp; Acts as a subject matter expert for internal stakeholders, including marketing, sales, and clinical teams&nbsp; Collaborates with internal teams (HEOR, access, marketing, sales) to&nbsp;maintain&nbsp;a customer-centric, compliant approach&nbsp;within assigned territory&nbsp; Establishes and develops HCP relationships, engaging in activities such as data discussions, clinical trials, and addressing patient journey barriers&nbsp; Responds to unsolicited information requests in&nbsp;a timely,&nbsp;accurate, and compliant manner&nbsp; Ensures compliant dissemination of scientific&nbsp;and clinical&nbsp;information to healthcare providers&nbsp; Manages administrative tasks (e.g., Veeva CRM, expense reports, compliance modules) efficiently, including customer profiling and keeping CRM information up to date&nbsp; &nbsp; Education&nbsp;and Skills Requirements:&nbsp; Advanced scientific degree or equivalent&nbsp;required&nbsp;(e.g., MD, PhD,&nbsp;NP, PharmD,&nbsp;PA)&nbsp; 10+ years of MSL&nbsp;experience is preferred Clinical experience within neuromuscular disorders (e.g., DMD, DM1) preferred; rare disease experience considered&nbsp; Strong knowledge of investigational products and the neuromuscular space, including emerging data&nbsp; In-depth understanding of clinical trial and investigator-sponsored study processes&nbsp; Proven ability to work effectively within multidisciplinary teams&nbsp; Clear understanding of MSL role and responsibilities&nbsp; Skilled in building and&nbsp;maintaining&nbsp;relationships with KOLs through scientific&nbsp;expertise&nbsp;and follow-through&nbsp; Ability&nbsp;to communicate research results clearly to diverse&nbsp;audiences&nbsp; Strong communication&nbsp;skills (written, verbal, presentation) for building relationships with colleagues&nbsp; Ability to influence without authority at all levels of the organization and externally&nbsp;&nbsp; Expert in planning, prioritizing, and executing tasks efficiently&nbsp; Capable of working independently and managing time in a home office&nbsp; Adaptable in ambiguous and dynamic environments&nbsp; Leverages past neuromuscular relationships to support study enrollment and site communication&nbsp; Experienced in relationship building to expand company reach&nbsp; Experience with relationship building and expanding a company’s reach&nbsp; Must be willing to travel extensively and occasionally on weekends&nbsp; Positive team member who embodies the Dyne Core Values&nbsp; Excitement about Dyne’s vision and mission&nbsp;&nbsp; Must be willing to travel extensively and occasionally on weekends &nbsp;MA Pay Range$183,000&mdash;$250,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The position is responsible for process development, technology transfer, and management of external CDMO activities to ensure development of robust and reliable GMP manufacturing processes for antibody oligonucleotide conjugates and intermediates. The Senior Scientist will represent CMC Process Sciences as a technical leader and provide guidance to internal process development staff and external vendors on oligonucleotide conjugate development and manufacturing activities from pre-clinical to GMP production for clinical evaluation (Phase 1-3). This includes active oversight of process establishment, process development, scale-down model verification, and process characterization. This person will also have direct oversight of CDMO technology transfer and process development operations. This position works closely with key stakeholders including Platform Research, External Manufacturing, Regulatory Affairs, and Project Management to meet the needs of Dyne’s complex clinical supply chain, supporting our preclinical and clinical programs. This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week. Primary Responsibilities Include: Responsible for drug substance bioconjugation including process development, tech transfer, scale-up, and process characterization of oligonucleotide conjugates. Lead internal CMC Process Development activities via hands-on contribution in the laboratory. Work with CDMOs to manage external process development, optimization, and tech transfer of new programs in a stage appropriate manner to ensure key milestones and products are delivered on schedule. Partner with Research to support bioconjugation development activities and enhance the tech transfer process to external manufacturing partners. Represent bioconjugation Drug Substance process as a technical leader in internal cross-functional CMC teams. Establish clear expectations and priorities, set objectives, and effectively apply resources to deliver on program goals. Select, qualify and manage external contract development and manufacturing organizations. Drive continuous improvement opportunities, adapt to and solve challenges and lead the timely resolution of issues. Evaluate and implement emerging technologies/applications to improve conjugation processes and optimize purification methods. Partner with internal cross functional teams and serve as the liaison to define suitable, compliant, and defendable CMC strategies. Prepare technical source documents, publications, and oral presentations. Prepare and review relevant CMC and product related sections and documentation for global regulatory submission. Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports. Education and Skills Requirements: PhD&nbsp;or equivalent experience&nbsp;in a scientific discipline and a minimum of 5+&nbsp;years&nbsp;related experience working with bioconjugates including a deep understanding of conjugation chemistries, preparative chromatography, and TFF.&nbsp; Experience in biopharmaceutical CMC management and/or Research &amp; Development preferably in a clinical-stage biotechnology company. Familiarity working with oligonucleotides including but not limited to morpholino oligonucleotides, antisense oligonucleotides, and siRNA is desired. Hands on experience with analytical techniques for characterization of conjugates including HPLC/UPLC, SEC, SDS-PAGE, ion exchange chromatography, and UV/vis. Experience with oversight of external contract development and manufacturing (CDMO) Ability to problem solve emerging issues related to drug substance development. A strong understanding of biologics and small molecule manufacturing, analytical development, quality control, quality assurance, and regulatory functions. Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment. Excellent interpersonal, organizational, negotiation, and communication skills; a team member that can work collaboratively with colleagues across functions. &nbsp; &nbsp; #LI-OnsiteMA Pay Range$147,000&mdash;$180,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Senior Scientist, Process Development - Bioconjugation

Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn&nbsp;and Facebook.Role Summary: The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of development, through and beyond product approval. This role plays a critical leadership role in enabling clinical registration, commercial readiness, and manufacturing lifecycle management by ensuring high-quality, compliant, and strategically aligned CMC regulatory submissions worldwide.&nbsp; The Director serves as a key strategic partner to Manufacturing, Quality, Clinical Operations, Program Teams, and the broader Regulatory organization, providing expert regulatory guidance, risk assessment, and leadership across early- and late-stage programs. This role operates with a high degree of independence and influence, contributing to program-level decision-making and organizational regulatory excellence.&nbsp; This role is based in Waltham, MA.&nbsp; Primary Responsibilities Include: Strategic Leadership &amp; Program Ownership&nbsp; Lead and execute global CMC regulatory strategies for assigned programs across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle management&nbsp; Serve as the CMC regulatory strategist and program leader, proactively identifying regulatory risks, opportunities, and mitigation strategies in alignment with development and commercialization objectives&nbsp; Provide strategic regulatory guidance to Manufacturing and Quality organizations to ensure global compliance and readiness for clinical and commercial supply&nbsp; Regulatory Submissions &amp; Health Authority Engagement&nbsp; Oversee the planning, development, and delivery of high-quality CMC sections for global regulatory submissions and responses to Health Authority questions, including clinical and commercial manufacturing changes&nbsp; Ensure alignment of CMC regulatory content with evolving regulatory expectations, guidance, and policy trends across regions&nbsp; Coordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities throughout the product lifecycle&nbsp; Cross-Functional Leadership &amp; Influence&nbsp; Act as the primary CMC Regulatory Affairs point of contact for cross-functional teams, providing clear direction on global regulatory requirements, timelines, and risks&nbsp; Represent Regulatory CMC in program,&nbsp;functional,&nbsp;and governance meetings, influencing decision-making without direct authority&nbsp; Partner closely with Manufacturing, Quality, Clinical Operations, and Program Management to deliver critical regulatory milestones&nbsp; Operational Excellence &amp; Knowledge Leadership&nbsp; Drive execution of regulatory policies, processes, and best practices to ensure consistent, compliant, and efficient regulatory operations&nbsp; Leverage deep technical and regulatory expertise to anticipate challenges and enable proactive problem-solving&nbsp; Mentor and support the development of regulatory team members, fostering a culture of collaboration, accountability, and continuous learning&nbsp; Contribute to the advancement of Dyne’s regulatory capabilities by sharing knowledge, lessons learned, and regulatory insights across the organization&nbsp; Education and Skills Requirements: Bachelor’s degree in life sciences or a related scientific discipline required; advanced degree preferred&nbsp; 10+ years of experience in the biotech or pharmaceutical industry, with a minimum of 7 years in Regulatory Affairs, including significant CMC regulatory experience in clinical-stage and/or commercial biotechnology companies&nbsp; Demonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA) strongly preferred&nbsp; Experience in rare disease drug development preferred&nbsp; Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements&nbsp; Experience with EU and international regulatory frameworks related to clinical and commercial development is a plus&nbsp; Deep understanding of the drug development process, accelerated regulatory pathways, and evolving global regulatory policy trends&nbsp; Extensive experience with CTD structure, content, and global submission requirements&nbsp; Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment&nbsp; Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations&nbsp; Exceptional written and verbal communication skills, including regulatory writing and executive-level communication&nbsp; Demonstrated ability to influence cross-functional stakeholders and senior leaders without direct authority&nbsp; Highly collaborative leader and team player with a strong cross-functional mindset&nbsp; Meticulous attention to detail with a commitment to quality and compliance&nbsp; Positive, proactive, and resilient leader who embodies Dyne’s Core Values&nbsp;&nbsp; Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases&nbsp; Ability to drive&nbsp;timelines, meet firm&nbsp;deadlines,&nbsp;and adapt quickly to changing requirements and priorities&nbsp; Embrace Dyne’s core values and culture&nbsp; #LI-OnsiteMA Pay Range$196,000&mdash;$240,000 USD&nbsp; The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.&nbsp; Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Executive Director, Clinical Development

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