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 Senior Scientist with the primary responsibility of providing expertise in the area of large molecule biodistribution and metabolism. A successful candidate will work closely with our bioanalytical scientists, biologics discovery, toxicology, clinical pharmacology, pharmaceutical sciences, and regulatory teams to optimize leads, to select candidates for clinical evaluation, and contribute to regulatory filings.
Specific Responsibilities:
The primary responsibility of this Biologics DMPK Senior Scientist position is to provide bioanalytical support and to characterize the absorption, distribution, metabolism, and excretion (ADME) properties of large molecule drug candidates using in vivo or in vitro imaging and non-imaging techniques. The Senior Scientist would serve as the department expert and would be responsible for developing ADME/biodistribution strategy for large molecules and novel modalities. He/she would also represent DMPK on project teams which includes the responsibility for the design and conduct of experiments to understand and predict the biodisposition and PK/PD behavior of large molecule clinical drug candidates.
Essential Duties and Job Responsibilities:
Serve on project teams at various stages of discovery and development as a subject matter expert on the ADME and biodistribution of large molecules.
Conduct internal/external bioanalytical and/or molecular imaging studies to characterize the biodistribution and metabolism of large molecules.
Analyze, interpret, summarize, and present PK and ADME data to internal project teams.
Prepare study protocols and coordinate execution of nonclinical PK or PK/PD studies 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 in pharmacokinetics, pharmacology/toxicology, immunology, biochemistry, bioengineering, or related biological sciences field.
3+ years of biopharmaceutical research experience in large molecule drug discovery, translational research, bioanalysis, and/or biodistribution discipline.
Proven track record of developing bioanalytic methods to assess PK, metabolism, and tissue distribution of large molecules using common platforms such as ligand binding assays, mass spectrometry, or other biodistribution methodologies.
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.
Preference given towards applicants with knowledge and/or experience in the application of routine PK and basic compartmental modeling software systems.