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: 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 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.

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