Sr Director, Drug Metabolism

Gilead Sciences•Foster City, CA

4d•Onsite

About The Position

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 Gilead Sciences, Inc. is a research-based biopharmaceutical company headquartered in Foster City, California, that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Together, We’re Creating What’s Possible! For more than 30 years, Gilead has pursued breakthroughs that were once thought to be impossible. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV, liver diseases, serious respiratory and cardiovascular conditions, cancer and inflammation. The Drug Metabolism and Pharmacokinetics (DMPK) group at Gilead Sciences is seeking a highly experienced candidate for the position of Senior Director of DMPK with the primary responsibility of providing expert PK support and serve as a DMPK project representative on biologics discovery and development project teams. A successful scientist will work closely with discovery bioanalytical, protein therapeutics, nonclinical toxicology, clinical pharmacology, pharmaceutical sciences, business development and regulatory teams to nominate candidates for clinical evaluation and contribute to regulatory filings.

Requirements

Requires a highly motivated individual with a PhD and 14+ years of post-graduate industry experience in the fields of pharmacokinetics, drug metabolism, pharmaceutics, or related life science field primarily supporting the PK characterization of large molecule/biologics through discovery and development.
Applicant must demonstrate excellent verbal and technical communication, independent scientific thinking, with the ability to interpret results, determine next steps and present data to project teams and senior management.
Applicant must demonstrate 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.
Applicant must be highly experienced in the application of PK-PD and multi-compartmental modeling software systems such as Phoenix/WinNonlin, MATLAB/Simbiology, or similar.
Knowledge in the application of large molecule/biologics ligand binding assays and LC/MS bioanalysis is highly desirable.

Responsibilities

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.
Interpretation and strategy 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.

Benefits

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 additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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