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Director DMPK



FibroGen, Inc. is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in fibrosis and hypoxia-inducible factor (HIF) biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer.


The Director of DMPK will provide technical and scientific leadership in establishing ADME/PK/PK-PD strategies for discovery and development program with small and large molecules. As a subject matter expert, they will collaborate closely with multiple R&D functional areas to support DMPK needs, enabling decision making for advancement of projects, including first-in-human dose predictions. The candidate will serve as DMPK program lead and is responsible for study design, execution, data interpretation and data reporting. Prior experience with preparation and review of regulatory filing documents to support IND, IB, FIH, CTA and NDA/BLA filings is essential. In this role you will: · Drive overall DMPK and PK/PD strategies. · Support discovery and development project teams across diverse therapeutic areas with small molecule and protein therapeutics. · Design, execute, analyze, and present DMPK data to internal project teams and senior management · Evaluate and interpret in vitro ADME data in the context of IVIVC/IVIVE · Design, analyze and interpret PK/PD studies to address translational questions in support of lead optimization and human active dose prediction · Manage collaborations with CROs for outsourcing activities and ensure high quality study execution to meet program timelines · Author and review DMPK sections of regulatory submissions, and respond to questions from regulatory agencies · Build and maintain strong collaborative partnerships with Chemical Sciences, Drug Discovery, Pharmacology, Toxicology, and Clinical Pharmacology groups



Requirements: · PhD degree in Pharmacokinetics, Drug Metabolism, or a related life sciences degree · Strong understanding of DMPK and PK/PD principles · Extensive experience in a wide variety of in vitro ADME assays, and deep fundamental understanding of mechanistic ADME, including a solid track record of publications in applying new science and technologies to enhance in vitro ADME assays · Expertise in mechanistic approaches and design/conduct relevant experiments to understand drug disposition profiles and PK-PD relationships for issue resolution, program advancement, and translation of dosage regimens from preclinical to clinical · Expert knowledge in interpretation and hands-on analysis of PK and PK/PD data using Phoenix WinNonlin and/or other analyses software packages (GastroPlus, Spotfire, StarDrop etc.) · Track record in leading small molecule drug discovery programs, demonstrated by successful advancement of discovery programs to IND filing · Extensive knowledge, and hands-on experience in developing in vitro/in vivo assays and in silico modeling tools to characterize preclinical ADME/PK and DDI profiles in support of lead optimization, candidate selection, and early development activities · A solid understanding of regulatory guidelines on DMPK studies to support early oncology drug development · Demonstrated leadership capability to mentor and develop junior scientists and build strong cross-functional collaboration · Excellent verbal and written communication, problem-solving, and critical thinking skills. · Thrives in a collaborative team setting and is driven by a desire to be innovative in a highly energetic and fast-paced environment

Location: San Francisco Bay Area


Post Date: 5/30/2023 3:17:39 PM
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