Vice President, Pharmacovigilance and Patient Safety

Role Summary

The Vice President, Pharmacovigilance and Patient Safety will join as a pivotal member of the Research and Development senior leadership team and play a significant role in managing the multiple facets of drug safety and pharmacovigilance focused on product development as the Company scales. This role leads the Pharmacovigilance and Patient Safety team, ensuring compliance with pre- and post-marketing regulations, and collaboration across executive and cross-functional groups. The position may be fully remote with occasional travel for in-person meetings.

Responsibilities

• Serve as the subject matter expert on global drug safety requirements in all phases of drug development and post-market support; lead the transition to global post-market drug safety and risk management.
• Represent the Pharmacovigilance and Patient Safety Department across all Day One Bio programs.
• Lead Safety Operations, including continuous safety data collection and compliant regulatory reporting.
• Lead pharmacovigilance signal detection, risk management activities, and risk mitigation strategies throughout product lifecycles.
• Provide oversight and management of pharmacovigilance agreements (PVAs) and relationship management with Development Partners.
• Evaluate overall safety profiles for investigational products and present safety data in cross-departmental safety review meetings.
• Identify matters needing escalation to upper leadership via internal safety governance processes.
• Coordinate with Regulatory Affairs to plan safety input into regulatory submissions and product labeling.
• Represent the company at Safety meetings and respond to regulatory safety inquiries; serve as Standing member and Deputy Chair of the Safety Review Board; be a member of the Senior Leadership Team.
• Provide drug safety expertise for pre- and post-approval documents; support Clinical Development, Clinical Operations, and Medical Affairs on safety issues.
• Participate in planning and approval of clinical trial safety documents and aggregate safety reports (e.g., DSURs, PADERs); review regulatory responses on safety.
• Assess global PV requirements for resources, equipment, and systems to maximize efficiency; ensure thorough collection and reporting of safety data; maintain risk-benefit balance.
• Develop risk management plans, pharmacovigilance strategies, and risk minimization activities; maintain a robust global safety database.
• Lead optimization of signal detection systems; represent Global Drug Safety at regulatory meetings and external conferences; collaborate with clinical development, medical affairs, regulatory, and commercial groups.
• Engage with business development for due diligence; interact with corporate partners on safety and pharmacovigilance matters.
• Hire, develop, and mentor the Pharmacovigilance and Patient Safety team; align organization with long-range business plan.

Qualifications

• M.D. or D.O. degree required with 15+ years‚Äô experience in a Drug Safety/PV Department in a pharmaceutical/biotech company.
• Therapeutic experience in pediatric medicine, pediatric oncology or adult hematological-oncology, or related areas is highly desirable.
• Entrepreneurial, small/high-growth company experience preferred.
• Experience leading a multifaceted team of safety physicians, safety systems, and operations personnel; ability to reevaluate team needs in an evolving company.
• Strong track record supporting regulatory submissions and product launches; experience developing PV processes to support product development to approval/post-market.
• Knowledge of current and emerging regulatory requirements (GCP, FDA, EU GVP, international guidelines).
• Extensive PV management experience from early to late-stage clinical settings; oversight of third-party safety activities and risk management.
• Proven safety lead for US and international health authority interactions, including pre-NDA/MAA IRs and post-marketing requirements.
• Ability to evaluate and interpret adverse event reports for safety submissions.
• Excellent interpersonal skills; strong relationship-building, negotiation, and program development abilities.
• Strong communicator, both orally and in writing; alignment with Day One Bio‚Äôs values.

Skills

• Pharmacovigilance leadership
• Safety data management and signal detection
• Regulatory affairs collaboration and submissions
• Risk management planning
• Team leadership and mentorship
• Cross-functional collaboration

Education

• M.D. or D.O. degree required

Additional Requirements

• Position may be fully remote; occasional travel for in-person meetings