Director, Safety Science

Job Summary

ABOUT IDEAYA:

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.

Notice To Agencies And Recruiters

All open positions and candidate activity are strictly managed through IDEAYA Biosciences, Inc’s Human Resources department. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes by agencies, with or without an agreement in place with IDEAYA Biosciences, Inc., will not create any implied obligation. Please note that failure to comply with this policy will be a factor in developing or continuing a professional relationship with IDEAYA Biosciences, Inc.

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.

Job Description

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.
  

Salary Range: $235,144 – $290,472

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.

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in ourSouth San Francisco, California office is $235,144 – $290,472.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.