Senior Director, Drug Safety and Pharmacovigilance

Job Details

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 , 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 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 :

#LI-Onsite

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. 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. 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.