Non-Solicitation Policy and Notice to Agencies and Recruiters:
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.Job SummaryAbout 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.
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.Location: South San Francisco or San Diego, CA.Position Summary:We are seeking an experienced Senior Medical Director of Patient Safety & Pharmacovigilance to join IDEAYA. 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 or San Diego offices and required to be onsite four days per week per our company policy.Job Description
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.
Total Rewards
Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, 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.
The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. 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). Therefore, 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.IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA 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.
EOE/AA/Vets.
