Senior Director, Drug Metabolism and Pharmacokinetics
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. 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/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
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Job DescriptionSpecific 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:
Knowledge, Experience and Skills:
- 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.
- 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.
The salary range for this position is: $230,860.00 - $298,760.00. 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 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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