Executive Director, Drug Safety; MD

Position: Executive Director, Drug Safety (MD)

We are seeking an Executive Director, Drug Safety (MD) to provide strategic leadership across all drug safety and pharmacovigilance activities for our clinical development portfolio.

This role requires a senior medical leader who can operate at the intersection of science, regulation, and business strategy—translating complex safety data into actionable guidance for executive leadership and regulatory bodies.
Key Responsibilities Strategic Leadership & Cross-Functional Collaboration
• Serve as the senior medical safety lead, collaborating with heads of Clinical Development, Medical Affairs, and Regulatory Affairs to address safety questions and deliverables across the organization.
• Develop and drive the overarching safety strategy for major functional areas involved in the clinical development of pharmaceutical and biotech products.

Provide ongoing counsel to senior management on the evolving risk-benefit profile of investigational products, ensuring timely implementation of safety updates and risk mitigation plans.
Regulatory & Health Authority Engagement
• Represent the company in interactions with executive-level management at global Health Authority organizations, negotiating complex matters to influence regulatory outcomes.
• Lead responses to safety inquiries from regulatory authorities, oversee agency audits, and manage corrective action plans related to drug safety.

Ensure all drug safety activities meet FDA, EU, and global regulatory requirements, ICH guidelines, and GCP standards.
Safety Operations & Reporting
• Direct the Drug Safety and Pharmacovigilance teams in managing patient safety and compliance with regulatory reporting obligations across all company-sponsored clinical trials.
• Oversee the development, preparation, and compliance of periodic and annual safety reports (e.g., US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, REMS where applicable).
• Guide safety review and input into all key clinical development documents, including protocols, amendments, ICFs, IBs, IMPDs, INDs, and CTAs.

Lead efforts for BLA and MAA filings for aggregate safety information.
Team Development & Compliance
• Recruit, develop, and mentor drug safety personnel; conduct regular performance reviews and provide coaching to direct reports.
• Chair one or more Safety Review Teams for assigned products, as directed by the Drug Safety Head.
• Ensure the department maintains readiness for internal and external audits through robust training, SOP development, and compliance programs.

Manage departmental budgets to align with corporate requirements.
Corporate & Departmental Development
• Participate in establishing strategic clinical development plans for investigational products alongside other senior leaders.
• Contribute to the development of departmental SOPs, Work Instructions, and corporate methods for evaluating projects, programs, and personnel.
Education

MD degree with completed residency (or equivalent) and/or board certification. Non-US medical degrees accepted with equivalent experience.
Experience
• Minimum of 15 years of relevant drug safety experience in the biotech or pharmaceutical industry.
• 8+ years of management experience preferred.

Extensive experience designing clinical studies and preparing aggregate safety reports for regulatory filings.
Required Knowledge & Skills
• Deep expertise in oncology and immune-mediated therapeutic approaches highly desirable.
• In-depth knowledge of FDA, EU, and global regulations, ICH guidelines, and GCPs governing drug safety and pharmacovigilance.
• Proficiency with safety databases; expertise in clinical safety assessment, signal detection, and risk management.
• Strong working knowledge of competitor product safety profiles within relevant…