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Director of Drug Metabolism and Pharmacokinetics (DMPK)

Cambridge, MA

Posted: 08/27/2020 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2623

Job Description

The Director of Drug Metabolism and Pharmacokinetics (DMPK) will be responsible for comprehensive DMPK support of all Discovery and Development programs. You will be a core member of the program teams providing DMPK perspectives and delivering on data that promotes program progression and de-risk company assets. Our client is currently focused on small molecules as the therapeutic modality and oncology as the priority disease area of interest and in this role you will devise, drive, and implement (with internal collaborations and working with consultants/external partners) strategies and analyses necessary to evaluate the performance of their lead compounds and drug candidates, enable IND and NDA filings of product candidates and further contribute to the optimization of our discovery and development programs. The successful candidate will bring extensive experience in ADME and DMPK to strengthen the discovery and development program teams and help drive programs to success.

How you will spend your day:
  • Responsible for in vitro ADME and animal PK study design and execution, data analysis and PK/PD correlation analysis
  • Designs, implements, drives, and monitors DMPK strategies for discovery programs
  • Responsible for gap analysis and modeling of HEDs from animal study data to aid in human starting dose selection, trial design, and/or program decision-making
  • Works with internal teams and external partners to execute discovery and development program team objectives
  • Works with medicinal chemistry and CMC team members to implement and execute on bioanalysis methods
  • Contributes to development program strategy, study execution, data review/analysis, study reports, protocol preparation and regulatory document preparation; write and review pre-clinical pharmacology summary documents
  • Oversees vendors and consultants as appropriate
  • Leads ADME and DMPK contributions to all regulatory documents. Leads the resolution of ADME and non-clinical DMPK queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries

Key things about you:
  • PhD in Pharmaceutical Sciences, or related field required
  • A minimum of 10 years’ experience in the biopharma industry in a DMPK role with at least 5 years in Oncology and proven ability to represent DMPK on project teams and with external partners
  • Experience with IND, NDA or BLA Oncology submissions and regulatory interactions
  • Experience partnering with Clinical Pharmacology, CMC, Translational Science and Discovery colleagues to ensure relevant DMPK strategy is developed
  • Experience working cross-functionally and working with external partners
  • Strong knowledge of the role of ADME and pharmacokinetics in drug discovery and development
  • Ability to perform in fast-paced, dynamic, constantly evolving environment
  • Excellent communication and organizational skills and attention to detail
  • Strong time management skills; ability to prioritize multiple tasks efficiently

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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