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 documents.
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 finalize reports.
Maintain complete and timely data archiving.
Coordinate operational logistics among in-house functions and external vendors.
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 projection.
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 predictions.
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 skills.