Medical Director, Drug Safety and Pharmacovigilance

About the role

IDEAYA is a precision medicine oncology company dedicated to developing transformative therapies for cancer. The Medical Director of Patient Safety and Pharmacovigilance plays a critical role in ensuring the safety and efficacy of our products.

Responsibilities

• Serve as the primary medical expert who performs and oversees medical review of ICSRs, including complex, and medically significant cases in the oncology therapeutic area
• Provide clinical assessment of adverse events, including causality, seriousness, expectedness, and review narrative content for clinical accuracy and flow
• Act as the primary medical point of contact for the pharmacovigilance vendor for day-to-day ICSR-related questions and escalation
• Support development of medical review guidelines, training materials, and vendor-facing instructions
• Collaborate closely with the IDEAYA Safety Operations team to ensure quality across global case processing activities by monitoring quality metrics and addressing non-compliance events
• Conduct and oversee thorough investigations of quality events, deviations and CAPAs pertaining to case processing and regulatory compliance
• Support development, implementation and tracking of CAPAs
• Participate in vendor governance meetings as the medical representative
• Support regulatory inspections, audits, and health authority inquiries related to ICSR processing and medical review
• Serve as the medical safety point of contact for any assigned molecule(s)
• Provide safety input for aggregate safety reports, protocol amendments, investigator’s brochure, informed consent and other key regulatory safety documents
• Partner with Safety Science, Regulatory Affairs, and Clinical teams as needed on safety issues requiring medical input

Requirements

• MD (or equivalent international medical degree) with 2+ years of bedside clinical experience
• 5–8+ years of oncology experience in drug safety/pharmacovigilance
• Strong hands-on ICSR medical review experience
• Demonstrated experience working with external PV vendors or CROs
• Solid knowledge of global PV regulations (FDA, EMA, ICH)
• Strong medical judgment, attention to detail, and ability to work effectively in a matrix environment

Qualifications

• MD (or equivalent international medical degree)
• 2+ years of bedside clinical experience
• 5–8+ years of oncology experience in drug safety/pharmacovigilance
• Hands-on ICSR medical review experience
• Experience working with external PV vendors or CROs
• Knowledge of global PV regulations (FDA, EMA, ICH)
• Medical judgment, attention to detail, and matrix environment experience

Skills

• Medical judgment
• Attention to detail
• Matrix environment experience

Benefits

• Comprehensive benefits package including medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
• 401k
• ESPP
• Wellness programs

Pay

The expected salary range for the role of Medical Director, Drug Safety and Pharmacovigilance is $268,000 - $331,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

Schedule

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.