Senior Medical Director, Patient Safety & Pharmacovigilance

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality, which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK, Amgen, Pfizer, and Gilead but wholly-owns or controls its three most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.   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 teamwork to move science forward. For more information, please see www.ideayabio.com.

Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com

Position Summary:  The Senior Medical Director will serve as the primary medical expert and leader for Ideaya Biosciences’ oncology drug development portfolio, focusing on patient safety, safety signal management, risk mitigation, and benefit-risk assessment strategies (BRAT/BRAD). Reporting directly to the Vice President of Drug Safety, this role is pivotal to the safety leadership team and involves strategic oversight, cross-functional collaboration, and interaction with external regulatory authorities. This position is based in our South San Francisco headquarter office or San Diego office and required to be onsite four days per week per our company policy.

What you'll do:

• Serve as the primary medical expert and leader for Ideaya Biosciences’ 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’s 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.

Requirements:

• 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.