Hiring company: Gilead
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 candidate for the position of Research Scientist with the primary responsibility to serve as a DMPK project representative on biologics discovery and development project teams. A successful scientist will work closely with biologics discovery, toxicology, clinical pharmacology, pharmaceutical sciences, and regulatory to optimize leads, to select candidates for clinical evaluation, and contribute to regulatory filings.
Specific Responsibilities:
The primary responsibility of this Biologics DMPK Scientist position is to serve as a DMPK project representative on biologics discovery and development project teams. The scientist would also be responsible for the design and conduct of experiments to understand the absorption, distribution, metabolism and excretion (ADME) properties of large molecule drug candidates.
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 input 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.
- Work closely with project teams, line management and CROs to assure high quality and timely delivery of written reports for regulatory submissions.
- Supervising research associate scientists may be required.
Knowledge, Experience and Skills:
- Requires a highly motivated individual with a PhD (0-2 years), or a MS degree with 6+ years, or a BS degree with 8+ years in pharmacokinetics, drug metabolism, pharmacology/toxicology, immunology, bioengineering, or related life science field and/or industry experience in large molecule/biologics 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.
- Knowledge and/ or experience in the application of routine PK and basic compartmental modeling software systems such as Phoenix/WinNonlin, ADAPT, MATLAB/Simbiology, or similar is required.