Associate Director, Patient Safety-Virology

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Job Summary

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 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.
• Contribute to activities related to regulatory filings and responses to safety queries from third parties, such as regulatory agencies, as needed
• Review of 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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.