Senior Manager, Drug Safety Operations

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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  are inquisitive, ask deep questions, and are data‑driven innovators who like to collaborate and use team work to move science forward.

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Location: South San Francisco

We are seeking a Senior Manager, Drug Safety Operations, to join IDEAYA as the operational leader for Individual Case Safety Report (ICSR) management. As Senior Manager, Drug Safety Operations, you will serve as the day‑to‑day operational lead and subject matter expert for ICSR execution across the development portfolio, working within the strategic and governance framework established by the Director of Safety Operations.

This role focuses on operational excellence, vendor performance, and case quality, with awareness of regulatory requirements and active collaboration with the Drug Safety Manager, Compliance and Vendor oversight, who retains primary responsibility for PV system compliance and governance.

This position is based in our South San Francisco headquarters and required to be onsite four days per week per our company policy.

Reporting to: Director, Safety Operations and Compliance

What you’ll do:

• Provide end‑to‑end operational oversight of ICSR intake, processing, follow‑up, quality control, and regulatory submissions performed by outsourced PV vendors.
• Maintain retained oversight of vendor case‑processing workflows to ensure accuracy, consistency, and compliance with IDEAYA SOPs and PV system expectations.
• Coordinate internal medical review activities (e.g., seriousness, expectedness, narratives, reporting decisions) in collaboration with Safety Physicians.
• Monitor case flow, prioritization, and handoffs to ensure timely submissions and adherence to internal quality standards.
• Review operational trends and quality indicators to proactively identify risks and drive corrective actions.

• Provide day‑to‑day operational oversight of PV CROs, ensuring adherence to SOWs, SLAs, SOPs, and defined workflows.
• Lead and facilitate routine operational governance meetings with…