Assoc Director, Patient Safety RM

This job is with Gilead Sciences Inc., an inclusive employer. At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

The Associate Director, Patient Safety provides strategic pharmacovigilance leadership for one or more products, compounds, or indications across the development and/or post marketing lifecycle. This role contributes safety expertise to ensure continuous evaluation of benefit-risk profiles, regulatory compliance, and patient safety, while serving as a key Patient Safety representative on cross functional teams.

The Associate Director operates with a high level of autonomy, partnering across functions to support product development, lifecycle management, and post authorization safety activities.

• Provide scientific input into pharmacovigilance activities, including safety surveillance, signal detection and evaluation, and benefit-risk assessments for assigned products and assisting with pharmacovigilance activities for other products when needed.
• Contribute to the development and execution of safety strategies across the product lifecycle, from clinical development through post‑marketing.
• Provide input into aggregate safety reports (e.g., PSURs/PBRERs, DSURs), regulatory submissions, and responses to health authority inquiries.
• Support risk management activities, including Risk Management Plans, risk minimization measures, and safety‑related labeling updates.
• Provide safety leadership and review of clinical study protocols, amendments, and study‑related documents.
• Serve, where applicable, as a medical monitor for post‑authorization, Phase 4, or observational studies, including investigator‑initiated and collaborative research.
• Represent Patient Safety on cross‑functional teams, collaborating with Clinical Development, Regulatory Affairs, Medical Affairs, RWE/HEOR, and other functions.
• Ensure pharmacovigilance activities are conducted in compliance with global regulations, internal SOPs, and quality standards.
• Contribute to inspection readiness, process improvement initiatives, and the ongoing enhancement of Patient Safety operating models.
• Build effective working relationships and provide thoughtful safety input to internal stakeholders to support patient‑centric decision‑making.

• Advanced degree in a scientific or medical discipline (e.g., MD, PharmD, PhD, or equivalent).
• Relevant experience in pharmacovigilance / patient safety within the pharmaceutical or biotechnology industry.
• Working knowledge of global pharmacovigilance regulations and aggregate safety reporting requirements.
• Demonstrated ability to evaluate safety data, apply clinical judgment, and communicate benefit-risk considerations.
• Experience working effectively in cross‑functional, matrix environments.

• Experience supporting safety oversight for products across multiple stages of the development or post‑marketing lifecycle.
• Prior involvement in safety signal evaluation, risk management activities, and regulatory interactions.
• Strong written and verbal communication skills, with the ability to present complex safety information to diverse stakeholders.
• Ability to manage multiple priorities and products concurrently in a fast‑paced environment.