Sr Director, Drug Metabolism

Job Description

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.

Job Title: Senior Director, Drug Metabolism and Pharmacokinetics (DMPK)

Job Type: Regular, Full‑Time

Location: Foster City, CA

The primary responsibility of this Biologics DMPK Senior Director position is to serve as an expert in the PK of biologics, representing the DMPK department by providing strategic and scientific leadership on large molecule discovery and development project teams. The position includes the responsibility for the design, supervision, and interpretation of experiments to understand the absorption, distribution, metabolism and excretion (ADME) properties of large molecule protein therapeutics.

In addition to serving as a project representative and departmental expert, he/she will have the opportunity to participate on business development and external research projects.

• Serve on project teams at various stages of discovery and development as a subject matter expert for DMPK Biologics, providing PK or PK/PD expertise to the design of nonclinical PK, toxicology, or pharmacology studies.
• Prepare study protocols and coordinate execution of nonclinical studies which may involve multiple functional areas and CROs.
• Design and perform complex PK‑PD analysis to answer translational questions in support of project deliverables and first‑in‑human dose predictions.
• Interpret and strategize for evaluating the impact of anti‑drug antibody (ADA).
• Participate in business development and licensing evaluations.
• Work closely with project teams, line management and CROs to assure high quality and timely delivery of written PK reports and regulatory documents (IND, IMPD, IB, BLA) for regulatory submissions.
• Supervising of research scientists and associate scientists may be required.

• PhD and 14+ years of post‑graduate industry experience in pharmacokinetics, drug metabolism, pharmaceutics, or related life science field primarily supporting the PK characterization of large‑molecule/biologics through discovery and development.
• Excellent verbal and technical communication skills, independent scientific thinking, with the ability to interpret results, determine next steps and present data to project teams and senior management.
• Intellectual curiosity and propensity to stay current with latest advances in DMPK of biologics and PK analysis, with a proven track record of sustained external visibility through publications, presentations and/or involvement in professional organizations.
• Highly experienced in the application of PK‑PD and multi‑compartmental modeling software systems such as Phoenix/Win Nonlin, MATLAB/Sim biology, or similar.
• Knowledge of large‑molecule/biologics ligand binding assays and LC/MS bioanalysis is highly desirable.

The salary range for this position is: $ – $. 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…