Dyne Therapeutics
Director, Drug Safety & Pharmacovigilance Scientist
Waltham, MA · Director
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About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- Conduct and lead safety surveillance activities for assigned clinical development programs, including ongoing review of aggregate safety data and identification of emerging safety trends.
- Contribute to safety-related sections of clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, reference safety information, clinical study reports, integrated safety summaries, briefing documents, and regulatory submissions.
- Maintain complete, accurate, and inspection-ready documentation of safety surveillance activities, safety decisions, and associated deliverables.
- Participate in safety governance forums and cross-functional program teams, providing scientific insight and recommendations to support decision-making.
- Develop, maintain, and enhance pharmacovigilance SOPs, work instructions, templates, and processes in alignment with global regulatory requirements and industry best practices.
Requirements
- 10+ years of relevant pharmacovigilance, drug safety, clinical development, or related biotechnology or pharmaceutical industry experience.
- Deep knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GVP, GCP, and applicable safety reporting requirements.
- Experience reviewing, analyzing, and interpreting clinical and safety data, including ICSRs, aggregate datasets, safety listings, tables, figures, and data visualizations.
- Working knowledge of safety databases, MedDRA coding, ICSR workflows, safety management plans, and pharmacovigilance vendor oversight practices.
- Proven success collaborating within matrixed organizations and influencing stakeholders without direct authority.
Nice to have
- MD, PharmD, PhD, or equivalent advanced degree preferred.
- Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology is preferred.
Compensation
- $220,000 - $240,000 USD
Benefits
- Lead signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management activities across the product lifecycle.
- Support medical and scientific review of ICSRs, including evaluation of case narratives, MedDRA coding, causality assessments, expectedness determinations, company comments, and follow-up activities.
- Develop safety monitoring strategies and risk mitigation plans that support effective benefit-risk evaluation.
- Author and contribute to safety signal assessment reports, aggregate safety reports, and safety analyses, including DSURs, PSURs/PBRERs, and responses to health authority safety inquiries.
- Influence safety-related discussions across development programs through clear communication of complex safety data and benefit-risk considerations.
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
This listing is sourced directly from Dyne Therapeutics's careers page and normalized into a canonical job model.