Spyre Therapeutics is a cutting-edge biotechnology company specializing in developing innovative therapies for a wide range of diseases. Founded in 2010, the company has been at the forefront of revolutionizing the healthcare industry with its groundbreaking research and development efforts. Spyre Therapeutics' commitment to advancing medical science has led to the creation of novel treatments that have the potential to significantly improve patient outcomes and transform the standard of care.

Staff Accountant, Finance

Clinical Trial Associate, Clinical Operations

Vice President, Pharmacovigilance

Senior Director, Clinical Operations

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary The Clinical Trial Manager (CTM) is a pivotal role responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. The CTM will organize and supervise clinical trials, ensuring they meet all company and regulatory requirements. The CTM will collaborate closely with internal R&amp;D team members in addition to external CRO partners to drive successful trial execution to advance the development of our cutting-edge antibody conjugate portfolio ensuring efficacy, safety, and regulatory success. Key Responsibilities Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion.&nbsp; Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements. Create and implement study-specific clinical monitoring tools and documents, including informed consent development and EU CTR. Lead the identification, evaluation, selection, and oversight of clinical trial sites. Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites. Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations. Responsible for implementation and oversight of Trial Master File for inspection readiness. Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates. Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents. Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members. Provide study updates and reports, inclusive of study risks and issues. Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events and study management meetings. Responsible for ongoing study data reviews and data cleaning activities. Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, interim monitoring and close out activities. Manage trial-level quality risk management. Oversee study supplies management. Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes. Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections. Other duties as assigned. Ideal Candidate B.A./B.S. in life sciences or equivalent&nbsp; A minimum of 7 years of clinical research experience within the pharmaceutical or biotechnology industry, with at least 2+ years managing early phase clinical trials; preferably managing global clinical trials&nbsp; Inflammation and/or Immunology experience is strongly preferred&nbsp; Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out Informed consent development and EU CTR experience&nbsp; Ability to lead cross functional study teams in a matrix organization Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions What We Offer Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $135,000 to $155,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Clinical Trial Manager, Clinical Operations

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Director of Clinical Pharmacology will play a pivotal role in leading our clinical pharmacology efforts to advance the development of our cutting-edge antibody portfolio. This position requires a strategic leader who can integrate clinical pharmacology and model-informed approaches into our drug development programs to ensure efficacy, safety, and regulatory success. Key Responsibilities: Lead the strategic planning and execution of clinical pharmacology analyses, including population and PK/PD and exposure-response modeling to support dose selection and clinical trial design. Collaborate closely with cross-functional teams, including clinical development, non-clinical development, DMPK, regulatory affairs, and clinical operations, to ensure alignment and integration of clinical pharmacology principles throughout the drug development process. Manage and collaborate with pharmacometrics vendors to support the pipeline. Support clinical pharmacology sections of regulatory submissions and interactions with health authorities worldwide. Stay abreast of emerging trends and regulations in clinical pharmacology and antibody development to ensure Spyre Therapeutics remains at the cutting edge. Additional duties as assigned.&nbsp; Ideal Candidate: Doctoral degree (MD/Ph.D./Pharm D) in Pharmacology, Pharmaceutical Sciences, or related field, with a strong focus on clinical pharmacology. A minimum of 5+ years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry, with significant experience in protein therapeutics. &nbsp;Experience with extended half-life biologics and/or combination products desirable. Fast and curious learner that thrives in fast-paced dynamic environment, with a proven ability to excel amid rapid change and shifting priorities. Proven track record of accomplishment in drug development, from early-stage research through to regulatory submission and approval. Experience with regulatory submissions and interactions with health authorities. Strong analytical and problem-solving skills, with expertise in PK/PD modeling and simulation, including Phoenix, R, and NONMEM. Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $ 225,000 to $246,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Director, Clinical Pharmacology

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: The Director, Drug Safety Physician will play a pivotal role on our Drug Safety &amp; Pharmacovigilance team, helping to advance the development of our cutting-edge antibody portfolio. This position’s deliverables include: Individual Case Safety Report (ICSR) review and aggregate safety monitoring (DSUR, etc.), oversight of cases/AOSE for expedited safety reporting, contributing to safety assessment, safety surveillance, signal detection, risk management planning and strategy, clinical trial document review (protocol, IB, ICF), and ensuring pharmacovigilance compliance with global regulatory requirements. Key Responsibilities: Perform triage and medical review of ICSRs (in or outside the global safety database), and oversight of cases/AOSE for expedited safety reporting&nbsp; Participate in the preparation, writing, and/or review of aggregate safety review documents (DSUR) and safety sections of relevant clinical trial documents and regulatory filings Participate in safety data review including safety surveillance activities and the evaluation &amp; management of safety signals emerging from any data source Participate and present cases at safety management team meetings and lead safety surveillance and signal management meetings&nbsp; Participate in process improvement projects related to medical review and assessment. Assist the DSPV department head in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures including SOPs, WI, surveillance plans &nbsp; Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings and present safety data at such meetings Ensure that tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements Provide medical safety strategy and execution of benefit-risk management strategies for assigned products Provide safety input to clinical development plans, responses to HA or institutional review board/ ethics committee queries Provide guidance to the development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development Provide input to other safety activities as requested Ideal Candidate: MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry Working experience / proficiency in Argus global safety database and medical review activities Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above &nbsp; Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $280,000 to $315,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Director, Drug Safety Physician

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: Reporting to the VP, Medical Affairs, the Medical Science Liaison is a therapeutic/disease expert responsible for scientific engagement with Thought Leaders and study investigators in achieving improved health outcomes for patients. This individual will provide strategic medical leadership within the Medical Affairs organization, ensuring scientific integrity, regulatory compliance, and effective communication between healthcare professionals, research teams, and business stakeholders. This role supports product development, clinical research, and medical education while driving evidence-based strategies to enhance patient care. This individual will be responsible for other field-based workstreams including local and national medical conference planning, investigator meeting support, advocacy organization engagement and advisory board participation. Key Responsibilities: Support research initiatives across development; provide support to clinical site investigators as needed Foster collaboration, trust and efficiency ensuring timely recruitment, high quality data and protocol adherence while supporting investigators and site staff. Recommend study sites and identifies potential investigators to participate in Clinical Development programs. Identify and engage Thought Leaders, active and potential study investigators, providers at academic and non-academic institutions and professional organizations within assigned geography. Effectively articulate relevant scientific and clinical information relative to therapeutic area and Spyre’s product life cycle to Thought Leaders and researchers. Ensure compliance with regulatory and ethical guidelines in medical communications Develop and oversee medical education programs and advisory boards. Stay up to date with industry trends, clinical advancements, and competitive intelligence to provide strategic insights. Represent the organization at conferences, medical symposia, and external meetings to facilitate exchange of scientific information with internal and external stakeholders. Identify issues related to patient enrollment and retention efforts in planned or ongoing company-sponsored clinical studies and communicates insights to Clinical Development team. Other duties as assigned. Ideal Candidate: PharmD, MD, PhD or similar with 3+ years of MSL experience. IBD and/or Rheumatology experience required. Strong understanding of drug development processes, regulatory requirements, compliance and healthcare trends. Excellent communication and leadership skills with the ability to engage diverse stakeholders. Strong team player with a demonstrated track record of success in a cross‐functional team and fast-moving environment. &nbsp;Work Location and Travel Requirements: This is a field-based position. Frequent travel with some overnight stay is required. This position requires the ability to drive within the assigned geographic territory by automobile and to travel by airplane or train. Occasional international air travel with multi-night stays. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $225,000 to $241,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Medical Science Liaison, Medical Affairs

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.&nbsp; Role Summary: The Senior Director of Clinical Development for Immunology and Inflammation will lead the clinical development strategy and execution for innovative therapies targeting immunological and inflammatory indications. The Senior Director will play a pivotal role as a clinical lead within our global clinical development programs, reporting into the SVP, Clinical Development. This role will design, plan, and implement study protocols, collaborate with cross-functional teams and support regulatory activities to advance the development of our cutting-edge antibody portfolio. This individual will join the Clinical Development tram at a relatively early stage and will play a key role in directing research and formulating strategy to drive program success.&nbsp; Key Responsibilities: Clinical Leadership: Provide strategic leadership and medical expertise for the clinical development of our cutting-edge antibody portfolio in I&amp;I indications. &nbsp; Trial Management: Oversee the study design, execution and interpretation of results, with a focus on proof-of-concept and later phases of development. &nbsp; Cross-functional Collaboration: Work closely with cross-functional teams including Biostatistics, Regulatory Affairs, and Development Operations to ensure integrated and strategic trial execution.&nbsp; Regulatory: Provide scientific/medical content and other input as appropriate for INDs, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Ensure compliance with regulatory standards and guidelines, including health authority requirements for MD sign-off on patient-related matters.&nbsp; Safety Oversight: Ensure the safety of study participants by actively participating in safety monitoring and data review processes.&nbsp; Stakeholder Engagement: Serve as the primary medical representative, interfacing with regulatory agencies, investigators, and KOLs.&nbsp; Other activities as required. Ideal Candidate: Education: MD or equivalent medical degree is required.&nbsp; Experience &amp; Skills:&nbsp; Minimum of 3-5+ years clinical development experience within the pharmaceutical or biotech industry within I&amp;I indications. Experience with antibody therapeutics preferred.&nbsp; Proven track record in designing and executing clinical trials in immunology or inflammation. Experience with regulatory filings and interactions with health authorities. Strong understanding of GCP, clinical trial design, statistics, and global regulatory processes.&nbsp; Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.&nbsp; Ability to manage complex projects in a fast-paced environment.&nbsp; What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $325,000 to $350,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp; &nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior Medical Director, Clinical Development

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: As the Senior Manager, Regulatory Affairs (CMC), you will play a key role in executing CMC regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities.You will lead submissions across multiple drug candidates and work closely with Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents. Key Responsibilities: Regulatory Submissions: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports. Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols. Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities. Strategy Implementation: Execute CMC regulatory strategies as defined by regulatory leadership to support clinical trial initiation and advancement. Cross-functional Collaboration: Partner with Technical Operations, Quality, Manufacturing, and external vendors to gather, verify, and compile CMC information. Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations. Other duties as assigned.&nbsp; Ideal Candidate: Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related experience. Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings. Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH. Experience with biologics, drug-device combination products (e.g., pre-filled syringes, auto-injectors), or diagnostics (companion diagnostics) preferred. Excellent attention to detail, technical writing, organizational, and communication skills. Ability to manage multiple deliverables and timelines in a fast-paced environment. Proficiency with regulatory document management systems. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $170,000 to $190,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Senior Manager, CMC Regulatory Affairs

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.Role Summary: As Senior Medical Writer, you will author and make key contributions to clinical and regulatory documents within our organization. You will be responsible for developing high-quality documents that support our clinical studies, including clinical study protocols, their amendments, clinical study reports (CSRs), investigator’s brochures (IBs), and annual reports, such as development safety update reports (DSURs). As needed, you will support other documents, such as clinical and nonclinical summary documents, reviewing ICFs, briefing documents, and responses to regulatory agencies.&nbsp;&nbsp;You will collaborate with cross-functional subject matter experts (SMEs) to meet aggressive timelines. You will project manage high-quality documents from start to finish, develop strong relationships, and be an advocate for best practices in Medical Writing. Key Responsibilities: Author clinical study protocols, amendments, IBs, and other supporting documents Review or develop document timelines in collaboration with our team and our CROs. Ensure that study documents will be authored, reviewed, and finalized in time for regulatory submission(s) and study execution.&nbsp;&nbsp; Co-author protocols and IBs with cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments). Coordinate the finalization and publication of documents. Review or contribute to supporting study documents, including (but not limited to) informed consent forms, study charters, or pharmacy manuals, if required.&nbsp; Author CSRs, clinical and nonclinical data summaries for INDs, CTAs, BLAs, and MAAs&nbsp; Work closely with clinical development, clinical pharmacology, translational science, data management, and/or biometrics SMEs, as well as the regulatory affairs and medical writing teams, to plan for the data that we expect to report in our CSRs. Co-author robust CSR shells in preparation for database lock(s).&nbsp;&nbsp; Co-author CSRs with accurate and concise interpretations of the results. Manage review cycles.&nbsp; Prepare clinical and nonclinical summaries for submission to regulatory agencies. Ensure key messages are clear and consistent across and within documents.&nbsp; Coordinate data integrity reviews of CSRs and data summaries, ensuring that the data and interpretations are consistent with TLFs and raw data.&nbsp; Assist with responses to information requests from regulators in a professional and efficient manner.&nbsp; Identify risks and contribute to risk mitigation or contingency planning for submission activities.&nbsp; Contribute to the maintenance of document templates, job aids, and training materials. Identify opportunities for process improvement.&nbsp; Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review. Other duties as assigned.&nbsp; Ideal Candidate: Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MS, PhD, MD, PharmD) is a plus.&nbsp; A minimum of 4+ years of regulatory medical writing experience within the biotech/pharmaceutical industry. Proven track record of successfully leading development of clinical study protocols, their amendments, study reports, investigator’s brochures, and other key clinical and regulatory submission documents.&nbsp; Experience managing nonclinical summary documents. Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.&nbsp;&nbsp; Knowledge of drug-drug and biologic-biologic combination products as well as the design of clinical studies for such products is a plus.&nbsp; Excellent leadership, collaboration, communication, and interpersonal skills.&nbsp; Strong problem-solving and critical thinking abilities.&nbsp; Ability to meet deadlines and adapt to changing priorities.&nbsp; Proficiency in word processing software and document management systems. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $130,000 to $145,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.&nbsp;As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Get a job referral to Spyre Therapeutics

Your career is worth investing in.

Get unlimited referrals with Premium.