Posted on: February 25, 2021
Get notified when the right job is available Our growing Small
Molecule client in Watertown, MA is growing and looking to bring on
board a Sr. Director, DMPK to join the Preclinical Development
team! The ideal candidate will partner with project teams to set
forth strategic DMPK paths to advance projects from early discovery
through clinical development. The ability to work effectively in a
collaborative, interdisciplinary team environment is essential to
this role with the expectation that this scientist will interact
with all disciplines of drug development, including medicinal
chemistry, biology, formulation, translational medicine, and
regulatory. Experience in small molecule drug discovery and deep
understanding in the key ADME processes or PK/PD modeling is
- Serve as the DMPK representative to ensure effective
application and integration of ADME, PK, and PK/PD studies in
support of discovery and development programs
- Identify critical ADME/PK needs and propose strategies
- Design and oversee DMPK studies, review and summarize results,
integrate ADME, PK, and PK/PD information to guide
multi-disciplinary team efforts in lead optimization and to
facilitate selection of development candidates.
- Deliver and communicate results to project teams, provide
intellectual input, and contribute to decision making.
- Collaborate with other functions such as biology and
translational medicine to define PK-PD relationships in preclinical
pharmacology studies and in clinic.
- Write and review relevant sections of regulatory
- Manage interactions with external CROs to ensure high quality
and on-time execution of DMPK studies.
- Identify and qualify external vendors for ADME/PK, Tox, and BA
support of research programs.
- Design study, review study protocol, study results, and
- Maintain complete and timely data archiving.
- Coordinate operational logistics among in-house functions and
external vendors. Requirements
- Master or PhD in drug metabolism, Pharmacokinetics,
Pharmaceutical Sciences, Pharmacology, or related disciplines with
15+ years (with MSc) / 5 - 10 years (with PhD) of relevant
experience in the pharmaceutical industry or CROs.
- In-depth understanding and strategic application of most in
vitro and in vivo ADME assays, methods and models. Ability to
gather most relevant information to facilitate human PK and dose
- Direct hands-on experience and strong trouble shooting skills
in most in vitro and vivo DMPK studies, including PK and PK/PD
analysis, quantitative and qualitative LC-MS analysis, in vitro and
in vivo biotransformation, and human PK and drug interaction
- Expertise in managing CROs and sound knowledge of regulatory
guidelines on DDIs, bioanalysis, and GLP practice.
- Proficiency in Phoenix WinNonlin (classic WNL and PHX Model).
Ability to develop user-specified mathematical models highly
desired. Familiarity with R and NONMEM a plus.
- Strong analytical, organizational, and communication
Keywords: HireMinds, Medford , Director, DMPK, Executive , Talent, Oregon
Didn't find what you're looking for? Search again!