DMPK Scientist / Associate Director

Pharsight   •  

Parsippany, NJ

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 89 days ago

This job is no longer available.

Responsibilities

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.

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