Senior Medical Director, Patient Safety & Pharmacovigilance

Role Summary

Senior Medical Director, Patient Safety & Pharmacovigilance guiding IDEAYA’s oncology drug development portfolio with a focus on patient safety, safety signal management, risk mitigation, and benefit-risk assessment strategies. This role reports to the Vice President of Drug Safety and leads safety leadership efforts, cross-functional collaboration, and regulatory interactions. Onsite four days per week at South San Francisco or San Diego offices.

Responsibilities

• Serve as the primary medical expert and leader for Ideaya Biosciences‚Äô oncology drug development portfolio, driving patient safety, safety signal management, risk mitigation, and benefit-risk assessment strategies (BRAT/BRAD).
• Report directly to the Vice President of Drug Safety and play a pivotal role on the safety leadership team.
• Foster collaboration across all levels of the organization and with external Regulatory Authorities. Attend Study Management Team meetings.
• Manage and mentor safety physicians and scientists, providing guidance and oversight to ensure operational excellence in safety practices.
• Develop, implement, and oversee signal detection strategies, leading the Safety Review Committee's executive meetings.
• Prepare, review, and oversee periodic safety reports, including IND Annual Reports, DSURs, PBRERs/PSURs, PADERs, and EU renewals.
• Author and review clinical trial protocols, Investigator‚Äôs Brochure (IB), Company Core Data Sheets (CCDS/CCSI), TPP, informed consent forms (ICF), and study-specific documents like BRAT and BRAD, ensuring alignment with benefit-risk profiles.
• Lead the creation of developmental risk management plans with input from cross-functional teams and provide strategic medical insights into regulatory safety assessments and inquiries.
• Contribute to and oversee the preparation of regulatory filings, including INDs, NDAs, and Marketing Authorization Applications.
• Participate in and provide input for Drug Monitoring Committees (iDMC) and contribute to scientific publications for meetings and journals.
• Support medical safety evaluations for new business opportunities and due diligence assessments.
• Recruit, hire, mentor, and manage direct reports, conducting performance evaluations and fostering professional growth.
• Collaborate with safety operations to ensure SOPs are developed, implemented, and compliant with regulatory and partner inspection requirements.
• Perform medical reviews of Serious Adverse Events (SAEs) and assist with narrative writing.

Qualifications

• M.D. or D.O. degree with completed residency training (mandatory).
• Minimum of 8 years of safety experience.
• Proven ability to establish, evaluate, and optimize safety-related business processes, tools, and systems.
• Strong expertise in global pharmacovigilance regulations and requirements (EMA, FDA, PMDA, Asia-PAC, ICH).
• Exceptional interpersonal, communication, analytical, and organizational skills.
• Demonstrated success in building and leading high-performing teams in a dynamic, fast-paced environment.
• Robust people and project management skills, with experience coaching and mentoring teams.
• Track record of managing safety leadership roles with cross-functional collaboration.
• Must be authorized to work in the United States on a full-time basis.

Skills

• Safety leadership
• Pharmacovigilance and BRAT/BRAD frameworks
• Regulatory reporting (DSURs, PBRERs/PSURs, INDs, NDAs)
• Cross-functional collaboration
• Medical review of SAEs and narrative writing
• Team building and mentorship
• Regulatory authority interactions

Education

• M.D. or D.O. with completed residency training