Senior Director, Drug Safety and Pharmacovigilance

Company Overview:

Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. 

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 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 the Head of Pharmacovigilance and PV Operations to prepare and maintain safety related SOPs in compliance with the global safety regulations and guidelines and provide relevant training as needed
• 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; completion of an accredited medical or surgical residency program and board certification are preferred
• Minimum 12 years’ experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including cross-functional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development