SVP Head of Pharmacovigilance

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.

Role Summary:

The Head of Pharmacovigilance will oversee Dyne's global PV systems, shaping strategy, processes, and compliance to ensure asset safety throughout their lifecycle. This peron will be a visionary leader with deep expertise in pharmacovigilance, risk management, and regulatory requirements to foster a strong safety culture. This individual will drive strategic implementation, execution, and cross-functional collaboration while engaging with external providers and regulatory authorities. As SVP, Head of Safety and Pharmacovigilance, they will lead safety datasets, provide medical oversight, and ensure proactive risk-benefit assessments. Responsibilities include regulatory interactions, PV team leadership, benefit-risk management, quality compliance, and safety signaling.

This role is based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

• Recruit, train, and mentor a high-performing pharmacovigilance team to support the company's growth and ensure operational excellence.
• Work closely with Regulatory Affairs, Clinical Development, and other teams to address safety-related regulatory actions and respond to health authority requests.
• Ensure adherence to global pharmacovigilance regulations and prepare comprehensive safety documentation for global filings.
• Ensure the pharmacovigilance function is prepared for regulatory inspections, maintaining high standards of compliance and documentation.
• Manage relationships with CROs to ensure high-quality pharmacovigilance services and compliance with regulatory requirements.
• Oversee medical safety and pharmacovigilance operations, ensuring efficient processes and adherence to best practices.
• Lead medical safety assessments, ensuring timely identification, escalation, and management of safety concerns.
• Support the preparation of safety-related sections for clinical and regulatory documents, including clinical study protocols, final reports, and integrated summaries of safety.
• Develop and implement risk management plans as needed and oversee post-market surveillance activities.
• Provide mentorship and guidance to internal team members, fostering professional development and a collaborative work environment

Education and Skills Requirements:

• MD required; board certification preferred.
• At least 20 years of experience in the pharmaceutical or biotech industry, including a minimum of 10 years in patient safety and pharmacovigilance. Expertise in post-market surveillance and global regulatory submissions, particularly with a focus on neurology/neuromuscular diseases, is highly desirable.
• Strong knowledge of US and international pharmacovigilance regulatory requirements, drug development process, and safety monitoring.
• Proven ability to lead multidisciplinary teams and manage pharmacovigilance vendors.
• Excellent communication skills for effective collaboration with internal teams and external regulatory bodies

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.