Senior Director/Executive Director, Head of DMPK
Posted on Apr 6, 2021 by Epizyme, Inc.
Reporting to the CSO, the Senior Director/Executive Director of DMPK will lead the DMPK group and drive strategic and tactical activities around DMPK, ADME, and PK, PK/PD.
Partner with project teams from early discovery through clinical development to identify critical ADME/DMPK needs and formulate strategy to address those issues.
Integrate in vitro and in vivo ADME results to establish best assays to understand and optimize compound properties in hypothesis driven way
Deliver data on aggressive timelines to guide medicinal chemistry efforts in optimizing PK properties
Partner with Biology and Clinical Pharmacology to establish and refine PK-PD-efficacy relationships
Collaborate with Toxicology to select appropriate preclinical toxicology species
Manage and mentor scientific staff
Provide detailed supervision of CROs in the execution and design of both standard and novel experiments to understand PK/PD and PK issues
Write and review documents to enable registration
Education and Requirements
PhD or equivalent in drug metabolism or related field with 10+ years of direct industry experience
Proven ability to drive drug discovery projects from early development through candidate selection and IND
Advanced knowledge of bioanalytics, mechanistic in vitro and in vivo experiments to determine cause of PK issues and scaling preclinical DMPK data to predict human PK and dosing schedules.
Firm understanding of the role of free drug in PK
Familiarity with current FDA and EMA guidelines a plus
Familiarity with clinical PK and outsourcing ADME studies a plus
Familiarity with PBPK a plus
Ability to collaborate across disciplines
Strong organizational skills, superior communication skills (both written and oral), and attention to detail are an absolute must.
Demonstrated experience in developing and successfully managing Research budgets and contracts.
Ability to work well under pressure and drive projects that affect critical timelines