Senior Director, Affiliate Safety Excellence

About Gilead

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.

About the Role

The Senior Director, Affiliate Safety Excellence is a vital strategic partner in advancing global pharmacovigilance excellence. Reporting to the Executive Director, Patient Safety, this role plays a pivotal part in shaping the future of patient safety through cross-regional integration, innovative strategies, and cross functional & external engagement. By fostering strong partnerships across global and affiliate teams, and driving forward-looking initiatives, the Senior Director ensures that safety practices and data analysis remain agile, aligned and patient-centered across geographies.

Key Responsibilities

Regional Strategy & Global-Affiliate Integration

• Develop and implement strategic frameworks to guide regional safety experts, QPPVs and Affiliate Heads of Patient Safety in product safety oversight in their regions
• Provide integration and learning of product safety profiles via collaboration between Patient Safety Therapeutic Teams and affiliate teams, ensuring bidirectional communication and strategic alignment
• Facilitate co-creation of best practices and harmonized safety processes across regions

External Landscape Monitoring & Strategic Foresight

• Contribute to horizon scanning across health authorities, industry trends, emerging technologies, and societal shifts that influence pharmacovigilance
• Help translate external intelligence into meaningful insights that inform global safety strategy and foster innovation
• Support representation of the organisation in external forums, regulatory roundtables, and industry collaborations, sharing perspectives and learning from others
• Act as a global ambassador and thought leader, proactively influencing regulatory evolution and industry, including EU and global regulations through participation in the PV Regulatory Intelligence Core Team and external forums such as IFPMA, helping shape discussions and build collective understanding

Safety Health Literacy & Insight Safety Strategy

• Provide expertise and guidance into the development of health literacy strategies that enhance patient understanding and engagement with safety information
• Collaborate cross functionally to embed health literacy principles into safety communications, labeling, and risk mitigation strategies
• Generate insights from patient experience, behavioral science, and communication research to inform safety practices
• Provide strategy for patient perspective and literacy testing strategies aligned with GVP Module XVI Revision 3

Operational Excellence & Innovation

• Promote continuous improvement initiatives across safety that have an impact on affiliates
• Promote innovation across tools, processes, and strategic foresight to future-proof pharmacovigilance capabilities across the Affiliate network

Regulatory Insight Leadership

• Leverage prior regulatory experience to anticipate agency expectations and shape internal safety strategies
• Partner with Affiliate Heads of Safety and wider Patient Safety and cross functional teams to ensure alignment between safety strategy and evolving regulatory frameworks
• Provide interpretation of complex and evolving regulatory guidance, translating implications into action to ensure appropriate risk management strategies via cross PS and cross functional collaboration

Qualifications

• Advanced degree in life sciences, pharmacy, medicine, or public health
• 12+ years of experience in pharmacovigilance, drug safety, or regulatory affairs, with global and regional exposure
• Proven leadership in external engagement, strategic planning, and cross-functional collaboration
• Expertise in health literacy, patient engagement, or safety communication is highly desirable
• Strong analytical, communication, and stakeholder management skills
• Previous experience as health regulator preferred

Application Instructions

For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

About Gilead Sciences, Inc.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.