Job Description
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 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. 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, 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 office 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 an