Sr Director, Drug Metabolism

职位描述

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.

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

Job Type: Regular, Full-Time

Location: Foster City, CA

Specific Responsibilities:

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.

Essential Duties and Job 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.

Knowledge, Experience and Skills:

• 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.