Director, Patient Safety (MD)

About this role

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.

Job Description  

Summary:

We are seeking a highly motivated and strategic Patient Safety Medical Review Physician (MD) to provide medical leadership and oversight of individual case safety report review activities across marketed and investigational products. This role is critical to delivering timely, high-quality medical safety assessments that support patient safety, informed benefit-risk evaluation, and regulatory compliance.

The Director will serve as a recognized expert in medical safety assessment and play a key leadership role in advancing the quality, consistency, and effectiveness of Medical Review activities. This includes overseeing peer retrospective medical review quality control (MRQC) activities, supporting audits and inspections, and driving the continued development and refinement of medical review processes, standards, practices, efficiencies, and capabilities.

As a medical review subject matter expert, the Director will provide medical consultation and strategic guidance to cross-functional partners. The successful candidate will bring strong clinical judgment, leadership presence, and communication skills, with a demonstrated ability to influence stakeholders, lead initiatives, and collaborate effectively across teams in a dynamic, fast-paced, and deadline-driven environment.

Key Responsibilities: • Establishes recognition as an expert on medical safety assessment of individual cases and line listings. • Performs peer retrospective medical review quality control activities. • Responds to medical review-related questions from other functions in a timely manner. • Collaborates with global safety leads and global safety strategy leads in assessment and communication of suspected unexpected, serious adverse reactions (SUSARs) reports from clinical trials. • Provides medical consultation to Patient Safety Strategic Operations functional groups including Literature Management, Coding Strategy, and Auto labeling Management on an ad hoc basis. • Makes significant contributions to the ongoing development and refinement of medical review processes, standards, practices, efficiencies, and capabilities. • May lead or contribute to develop and maintain procedural document for medical review activities and provide training. • Supports internal and external audit and inspection. • Participates in both internal and external educational initiatives. • Makes contributions to process improvement within Patient Safety , particularly with adverse event processing and operational aspects. • Initiates, leads, or contributes to functional or cross-functional projects. • Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements. • Provides mentorship and trains junior staff, new hires, and contractors to independently review adverse event reports for investigational and marketed products.

Basic Qualifications: • An MD/DO degree or equivalent.

Preferred Qualifications: • Completion of an accredited medical or surgical residency program. Board certification is preferred.   • minimum of 4 years’ experience in medical review or • OR an applicable role in the pharmaceutical industry with strong knowledge of global regulatory requirements.  

• Excellent scientific, clinical, and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications. • Exceptional communication, collaboration, and project management skills. • High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset.

People Leader Accountabilities: • Create Inclusion - recognize the business value of diverse teams, modeling inclusion, and embed 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.

  The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For addit

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