Senior Medical Director, Patient Safety & Pharmacovigilance

IDEAYA Biosciences • South San Francisco, CA

3d • 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.

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.
• 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.

Responsibilities

• 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.

Benefits

• Merit-based salary increases
• Company discretionary short-term incentive plan participation
• Company discretionary stock option awards (based on board approval)
• Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
• 401k
• ESPP
• Wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree