Director, Safety Science

Company: IDEAYA Biosciences
Location: San Diego
Posted on: April 2, 2025

Job Description:

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, Merck, Pfizer, and Gilead but wholly-owns or controls its four 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 .Position Summary:Reporting to the Vice President of Drug Safety, this role leads safety monitoring for investigational and marketed products, ensuring compliance with corporate strategies and regulatory standards. Responsibilities include managing safety deliverables (e.g., governance, signal detection, reporting), supervising safety scientists, and conducting safety analyses. The position oversees Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and the preparation of regulatory safety documents (e.g., PBRERs, DSURs, NDAs). It involves cross-functional collaboration on signal detection, risk management, and benefit-risk assessments, while maintaining expertise in drug safety and regulatory trends. Additional duties include vendor oversight, process improvements, and participation in audits and inspections.This position is based in our South San Francisco headquarter offices or San Diego office and required to be onsite four days per week per our company policy.What you'll do:

• Report directly to the Vice President of Drug Safety and indirectly to the Senior Medical Director of Drug Safety.
• Lead safety monitoring for investigational and marketed products, ensuring alignment with corporate development strategies.
• Oversee core safety deliverables, including safety governance, signal detection/management, periodic/aggregate reporting, and case processing.
• Supervise and mentor all safety scientists, fostering a collaborative and high-performing team.
• Conduct safety analyses using case series, data summaries, adverse event trends, and clinical/post-marketing data.
• Review medical and scientific literature for signal detection and aggregate reporting.
• Develop and maintain product-specific Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Perform safety data monitoring, interpretation, and analysis.
• Lead the preparation of safety deliverables, including integrated safety reports and regulatory documents (e.g., PBRER/PSUR, DSUR, PADERs).
• Provide safety input to clinical documents such as Investigator's Brochures, study protocols, and clinical study reports.
• Ensure consistency in safety and risk management content across regulatory submissions.
• Partner with safety physicians and cross-functional teams on signal detection and risk management activities.
• Participate in safety governance meetings and contribute to benefit-risk assessments.
• Author and review safety sections for regulatory packages, including NDAs and responses to health authority queries.
• Support pharmacovigilance vendor oversight, process improvement initiatives, and inspections/audits.
• Maintain up-to-date expertise in disease areas, drug safety, regulatory trends, and business practices.Requirements:
  • PharmD, RN, or MD required; advanced degrees (e.g., Master's) preferred.
  • At least 6 years of experience in patient safety and pharmacovigilance, including team management.
  • More than 3 years of experience authoring and reviewing periodic/ad hoc safety reports and clinical documents (e.g., PSURs, DSURs, Clinical Overviews).
  • Expertise in safety analyses, signal detection, risk management, and health authority responses.
  • Experience with NDA/MAA filings.
  • Strong ability to interpret and integrate safety data.
  • Effective communication skills (written and verbal) for internal and external audiences.
  • Proven leadership in mentoring and managing scientific teams.
  • Must be authorized to work in the United States on a full-time basis.
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Keywords: IDEAYA Biosciences, San Diego , Director, Safety Science, Executive , San Diego, California