Vice President, Pharmacovigilance and Patient Safety

M.D. or D.O. degree required. 15+ years’ 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 therapeutic experience is highly desirable. Entrepreneurial, small/high growth company experience preferred. Experience leading a multifaceted team of safety physicians, safety systems, and operations personnel. Strong track record of supporting regulatory (IND, NDA/BLA, MAA) and product launch success. Solid knowledge of current and emerging regulatory requirements and expectations including GCP, FDA, and EU GVP regulations and international guidelines. Extensive Pharmacovigilance management experience in early to late-stage clinical settings. Proven Safety lead for US and OUS health authority interactions. Ability to evaluate and interpret adverse event/serious adverse event reports. Excellent interpersonal skills, ability to develop strong relationships, skillful conflict management and negotiation skills. Strong and clear communicator, both orally and with the written format. Embrace Day One Bio’s core values.

Serve as SME on global drug safety requirements in all phases of drug development. Represent the Pharmacovigilance and Patient Safety Department. Lead and oversee Safety Operations including data collection and regulatory reporting. Lead and oversee Pharmacovigilance signal detection, risk management, and mitigation. Provide oversight and management of pharmacovigilance agreements (PVAs). Ensure ongoing evaluation of product safety profiles and present safety data. Identify matters needing escalation to upper leadership. Support safety input into regulatory submissions and product labeling. Represent the company at Safety meetings and lead responses to regulatory enquiries. Provide drug safety expertise and review for pre- and post-approval documents. Support Clinical Development, Clinical Operations, and Medical Affairs with safety issues. Participate in planning, review and approval of clinical trial safety documents and aggregate reports. Provide input and review of responses to regulatory agency safety questions. Assess global PV requirements for resources, equipment, and systems. Ensure thorough collection and reporting of safety data. Develop overall risk management plans, pharmacovigilance strategies, and risk minimization activities. Ensure robust integrity and maintenance of a global safety database. Lead optimization of the signal detection system. Represent Global Drug Safety at regulatory authority meetings and external conferences. Lead cross-functional and cross-departmental interactions. Collaborate with business development for due diligence activities. Interact and represent safety and pharmacovigilance with Corporate Partners. Hire, develop, and mentor the Pharmacovigilance and Patient Safety team. Assess and align the organization to meet long-range business plan goals.