Senior Medical Director, Patient Safety & Pharmacovigilance

Job Summary

About IDEAYA Biosciences: 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.

Position Summary

We are seeking an experienced Senior Medical Director of Patient Safety & Pharmacovigilance to join IDEAYA.

Job Description

• 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.
• 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.

Total Rewards

• A competitive total rewards package that reflects our pay-for-performance philosophy.
• Merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).
• Comprehensive benefits package including medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.
• The expected salary range for the role of Senior Medical Director, Patient Safety & Pharmacovigilance is $287,000 – $355,000.
• 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.

Pay

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 requires you to work onsite in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).

The Company complies with all laws respecting equal employment opportunities and does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status.