Associate Director, Patient Safety

The Associate Director, Patient Safety‑Virology 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.

Key Responsibilities

• Provide scientific input into pharmacovigilance activities, including safety surveillance, signal detection and evaluation, and benefit–risk assessments for assigned products and assist 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.
• Contribute to activities related to regulatory filings and responses to safety queries from third parties, such as regulatory agencies, as needed.
• Review clinical study protocols, amendments, and study‑related documents.
• 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.

Education and Experience Requirements

• PharmD/PhD with 2+ years’ relevant experience.
• MA/MS/MBA with 8+ years’ relevant experience.
• BA/BS with 10+ years’ relevant experience.
• 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.

Preferred Qualifications

• 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.

People Leader Accountabilities

• Create Inclusion – knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent – understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential.
• Empower Teams – connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company‑sponsored training, education assistance, social and recreational programs are administered on a non‑discriminatory basis.