The Executive Director, Drug Safety (Head of Safety) will serve as the company’s senior authority for drug safety and pharmacovigilance (PV), responsible for developing and executing global safety strategies across all clinical programs. This leader will report to the CMO and will be responsible for overseeing safety science, signal management, and vendor/CRO oversight while building scalable processes that align with the company’s growth trajectory.

The ideal candidate is a hands-on, scientifically grounded safety leader who can operate strategically and tactically—comfortable engaging with executive leadership, regulators, and external partners, while also helping shape the company’s long-term safety function.

Key Responsibilities

1. Establish and lead the company’s global safety and pharmacovigilance function, ensuring compliance with regulatory standards and alignment with clinical and corporate objectives.
2. Serve as the company’s senior safety expert for all programs, providing leadership on benefit–risk evaluation, safety signal assessment, and regulatory safety strategy.
3. Provide safety input into clinical protocols, Investigator’s Brochures, and regulatory submissions, including INDs, DSURs, and future NDA/BLA filings.
4. Lead safety-related interactions with global regulatory authorities (FDA, EMA, MHRA, PMDA, etc.), including participation in agency meetings and preparation of responses to safety inquiries.
5. Oversee and manage full-service CROs responsible for safety case management, ensuring quality, compliance, and scientific rigor.
6. Develop and maintain safety governance policies, SOPs, and operating procedures, appropriate for a growing global organization.
7. Build and mentor a high-performing internal safety team, including internal staff and external consultants.
8. Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biometrics, and Quality to ensure integrated safety strategies and consistent data interpretation.
9. Support strategic growth initiatives, including due diligence and safety assessments for potential partnerships or in-licensing opportunities.

Qualifications

Required:

• M.D. (preferred) or Pharm.D./Ph.D. with extensive experience in drug safety and pharmacovigilance.
• Minimum 12 years of experience in clinical development and safety, with at least 4 years in a leadership role.
• Strong background in oncology drug development, preferably with small-molecule therapeutics.
• Demonstrated success in building or scaling a pharmacovigilance function within a growing biotech or mid-size company.
• Proven experience in CRO oversight for safety and operational activities.
• In-depth knowledge of global PV regulations, ICH guidelines, and regulatory expectations across development phases.
• Familiarity with safety databases (e.g., Argus, ArisG) and vendor qualification processes.
• Excellent communication and leadership skills, with the ability to influence internal and external stakeholders.

Preferred:

• Experience leading safety strategy through regulatory submissions and global filings.
• Experience integrating safety systems and workflows in growth-stage environments.