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Pfizer
     
 
Associate Director, DMPK/Clinical Pharmacology
 
     
 
Company: Agios Pharmaceuticals
Location: Cambridge, MA, USA
Job Title:
Associate Director, DMPK/Clinical Pharmacology
To Apply: Send CV and cover letter to Laurie.Rose@agios.com
 

     
 
General Summary:
Agios Pharmaceuticals is searching for a dynamic Principal Scientist/Associate Director to join our growing DMPK/Clinical Pharmacology team.  This person will be responsible for designing, and analyzing in-vitro and in-vivo studies addressing issues related to metabolism and drug-drug interactions in both discovery and development programs in this individual contributor position. Further, this person will carry out strategies for ensuring that molecules are optimized with respect to in vitro ADME properties before molecules are transitioned into development, and for determining the metabolic fate of molecules during preclinical and clinical development. The incumbent is also responsible for writing the nonclinical metabolism and in vitro ADME sections of regulatory documents (IND/IB/NDA).

 
 
Key Responsibilities:
  • Design, plan, prioritize and conduct experiments through CROs for in vitro/in vivo ADME studies of drug candidates in laboratory animals and humans using radiolabeled and non-labeled drugs in support of Discovery and Development.
  • Analyze the in vitro data, provide DDI risk assessment and issue management, including DDI related exclusion criteria for clinical trials.
  • Manage existing CROs for metabolite ID, radiolabeled ADME studies, in vitro metabolism, CYP /transporter inhibition/induction studies.  If need be, Visit, evaluate and identify additional/other sites.
  • Review the reports from CROs for the designated projects and ensure that all critical studies are completed with quality work and finalized for submission to regulatory agencies.
  • Write/review preclinical and clinical ADME sections for Common Technical Document (CTD) to support regulatory (IND/IB/NDA) filings and provide response to regulatory queries related to DMPK/DDI.
  • Provide metabolism data and scientific scholarship to early discovery programs to select molecules with optimal ADME properties.

 
 
Minimum Requirements:
  • Ph.D. or equivalent in Biochemistry, Medicinal Chemistry, or related metabolism science with 8-12 years of relevant industry experience in a drug discovery and development environment.
  • In-depth conceptual and technical expertise in drug metabolism for small molecule discovery and development programs, and ability to provide strategic and scientific direction in this area.
  • Capable of working independently within a highly matrixed environment and to able provide cross-functional support for teams.
  • Demonstrated success managing interactions with external CROs, consultants and other contract organizations.
  • Excellent organizational, interpersonal and verbal/written communication skills and ability to perform as an effective, flexible and self-assured team player.
  • Highly effective in team settings – willingness to openly share ideas and expertise.
  • Ability to thrive in a fast-paced and dynamic environment with frequent course corrections.

 
 
Preferred Qualifications:
  • Hands-on experience on mass spectrometry as applied to in vitro & in vivo drug metabolism.
  • Experience in writing in vitro/in vivo ADME reports and regulatory documents for world-wide submissions.

 
     
  Contact Information:  
 
Please send CV and cover letter to Laurie.Rose@agios.com
 
 
 
 

Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has one approved oncology precision medicine and multiple first-in-class investigational therapies in clinical and/or preclinical development.