The DMPK Scientist/Associate Director may conduct any or multiple of the following activities as a billable consultant (~80% of “time in the office”), in the areas of DMPK, clinical pharmacology and data analysis (as appropriate):
Aid in the design, management and monitoring of drug metabolism and metabolite ID studies conducted at Contract Research Organization laboratories.
Review metabolism and metabolite ID data, study results, interpretation and reports.
Utilize in vitro study results to inform in vivo study strategy/needs.
Contribute to lead optimization by working closely with medicinal chemists and help devise SAR strategies for ADME related properties.
Contribute to DMPK sections of regulatory documents (IND, IB, NDA).
Conduct data analyses (e.g., NCA, popPK, PBPK).
May participate in company initiatives to improve efficiency of processes, analysis and reports (e.g. IT, methodology, efficiency, automation, quality).
Education & Experience
MS or PhD in chemistry, biochemistry or other field with strong spectroscopy training.
5+ year industrial experience as a DMPK project representative to preclinical or clinical project teams and/or served as an investigator in ADME lab.
Thorough understanding of the basic principles of pharmacokinetics for small and large molecules.
Track record of scientific accomplishment as evidenced by quality and quantity of publications and/or inventions.
Technical expert in drug metabolism and metabolite ID topics across pre-clinical and clinical stage.
Familiarity with ICH, FDA and EMA guidance’s pertaining to drug metabolism and metabolite safety testing.
Experience designing and interpreting human ADME studies.
Experienced in the design and conduct of transporter studies.
Familiar with the various flow charts/decision trees employed in Regulatory Strategy and decision making.
PK analysis experience including NCA. Some experience and expertise in modeling such as PK/PD and PBPK is desirable plus.
Experience with Human PK and efficacious dose projection.
Skills & Abilities
Excellent written and oral communication skills to effectively communicate complex research findings and recommendations, and seek to excel in a multi-disciplinary team environment.
Ability for critical thinking and strong analytical skills to evaluate complex information for the identification of key scientific findings related to projects.
Ability to prioritize and manage multiple projects and activities while meeting deadlines.
Maintains excellent working relationships with colleagues and collaborators.
Ability to work independently incorporating cross functional team members as required.
Comfortable in a client environment able to communicate with and collaborate with peer scientists.