Director, Safety Science

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, Amgen, Pfizer, and Gilead but wholly-owns or controls its three 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 www.ideayabio.com.

Notice to Agencies and Recruiters:

All open positions and candidate activity are strictly managed through Human Resources. 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 prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to [email protected].

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. 

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 our South San Francisco or San Diego, California office is $262,263 - $276,640.

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 at the Company’s facilities, with partial 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.

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. 

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.

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