Sr. Manager, Clinical Pharmacology

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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
 

POSITION OVERVIEW:

With increasing independence, you will typically lead clinical pharmacology studies of moderate complexity in Inflammation, which range from first-in human through approval and post-marketing activities. Working in collaboration with others, you are responsible for various aspects of clinical pharmacology program activities. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical pharmacology study start-up/execution/close out, PK-PD and related analysis, interpretation and reporting, and support of regulatory filings. You will typically lead clinical pharmacology cross-functional study sub-teams, which entails coordinating and providing direction to internal and external partners involved in clinical pharmacology study design and execution. You will champion model-based drug discovery and development and serve as a clinical pharmacology specialist to cross-functional partners.

RESPONSIBILITIES:

• As a member of a drug development team, provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
• May author the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area.
• Typically leads and manages design and conduct of clinical pharmacology studies of moderate complexity, which typically includes responsibilities for leading the respective cross-functional study team.
• With input from others, designs clinical pharmacology study protocols, study data analysis
• Leads study protocol review discussions concerning scientific and procedural aspects of pharmacology study design.
• Works with cross-functional partners and study sites to implement and monitor clinical pharmacology studies. Addresses clinical issues arising from clinical pharmacology studies.
• Directs the activities and resources for both internal and external study partners.
• Manages study timelines and resources to ensure timely and accurate execution of clinical pharmacology studies.
• Conducts PK-PD and related analyses and provides clinical pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific presentations or literature.
• Analyzes, interprets and authors documents for clinical and regulatory submissions.
• Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies.
• Presents project updates and other key milestone information to cross-functional partners and stakeholders.
• Anticipates problems that may arise in clinical trials and develops solutions for these using precedents and original thin