Scientist/Senior Scientist_ DMPK/Bioanalysis (PK Scientist)
MPM NewCo is an exciting, fast-growing start-up company in the development of novel, breakthrough therapeutics. We are looking for talented scientists in DMPK support the non-clinical studies for the company’s diversified programs. The individual will actively participate in program teams, design PKPD studies, conduct the ADME experiments, perform PKPD data analysis, modeling and simulation, and present results in the program meetings. The job responsibility will be balanced with lab- and office- based activities. The individual will work with a vibrant multi-disciplinary team and grow your career with increased responsibilities. This position will directly report to the head of DMPK/bioanalysis.
- Serve as the DMPK project lead to ensure effective application and integration of ADME, PK, and PK/PD studies in support of discovery 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.
- 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.
- MSc or PhD in Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related disciplines.
- 10+ years (with MSc) or 3+ years (with PhD) of relevant experience in the pharmaceutical industry or with CROs.
- Knowledge and experience in RNA-related therapeutics and lipid delivery will be plus.
- 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.