Vice President, Head of Global Patient Safety & Risk Management
$322,000–$455,000 year
HybridWatertown, Massachusetts, United States or Massachusetts, United States
Job Summary
Lead global pharmacovigilance and drug safety strategy for the clinical pipeline, representing the safety function as a strategic partner to executive leadership and development teams. Develop and execute safety governance, oversee medical review of ICSRs, and manage regulatory interactions including responses to health authority inquiries. Build and mentor a high-performing organization while ensuring compliance with FDA, EMA, and ICH regulations across pre- and post-marketing operations. This role reports to the Chief Medical Officer and involves transitioning into a late-stage biotherapeutics organization. Disc Medicine is a clinical-stage biopharmaceutical company focused on hematologic diseases, offering a flexible hybrid work environment in Watertown, MA.
Required Qualifications
- MD preferred, but highly effective leaders with PharmD, PhD (or equivalent advanced sciences degree) backgrounds encouraged to apply
- Minimum of 15 - 20 years of progressive drug safety & pharmacovigilance experience in the biotechnology or pharmaceutical industry
- at least 5 years in leadership or management capacity
- Deep expertise in safety surveillance, signal and risk management, benefit-risk assessment, global safety reporting requirements, and safety aggregate reports across all phases of clinical development
- Comprehensive mastery of FDA, EMA, GVP, and ICH regulations and guidelines
- Demonstrated experience supporting successful regulatory submissions including NDA, BLA and/or MAA filings and global health authority interactions
Desired Qualifications
- entrepreneurial spirit
- drive for excellence
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