Medical Director, Drug Safety and Pharmacovigilance

IDEAYA Biosciences•South San Francisco, CA

5d•$268,000 - $331,000•Hybrid

About The Position

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com. We are seeking an experienced Medical Director of Patient Safety and Pharmacovigilance to join IDEAYA. The Medical Director, Medical Safety – ICSR provides medical leadership and clinical oversight for Individual Case Safety Report (ICSR) activities across the company’s global pharmacovigilance program. This role is primarily responsible for high-quality medical review of safety cases and serves as the key medical interface with the company’s pharmacovigilance vendor for day-to-day case processing activities. The role partners closely with Safety Operations, who shares responsibility for vendor oversight related to case processing, quality, and compliance. Together, they ensure timely, consistent, and inspection-ready safety reporting in a growing organization. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

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
All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct. Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels
This position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

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
Provide medical input into vendor oversight activities, including case quality review, accuracy of triage, and regulatory submission compliance
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 address 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
Contribute to the development and maintenance of SOPs and work instructions related to medical case 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