Executive Director, DMPK

3 weeks ago

Boston MA, United States Nimbus Therapeutics Full time

Nimbus has an outstanding opportunity for an exceptional Executive Director, DMPK to join our team. This role will serve as the function head, applying subject matter expertise in absorption, distribution, metabolism, and excretion (ADME), pharmacokinetics, and pharmacodynamics, along with effective team management skills, to drive the strategy and execution of our clinical development and pre-clinical programs. You will report to our Senior Vice President of Nonclinical Sciences.

In This Role, You Willl:

  • Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates that support both drug discovery and preclinical and clinical development
  • Responsible for the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external collaborators
  • Represent DMPK as the subject matter expert to project teams
  • Establish effective relationships with CROs, consultants, and internal team members to develop and qualify various analytical and bioanalytical methods.
  • Design, contract and manage CRO in the conduct of in vitro / in vivo ADME studies. Review study protocols and reports, interpret and communicate results
  • Prepare strategic and scientifically sophisticated ADME strategies that meet regulatory requirements and program goals
  • Author, review and approve scientific reports that support regulatory documents including INDs, CTAs, and NDA filings.
  • Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
  • Provide leadership and management support for nonclinical DMPK that can build and inspire our teams and drive collaboration and innovation

These Qualifications Will Help This Role Be Successful:

  • Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutical Science or other relevant field with 15+ years of experience in the biopharmaceutical industry
  • Strong knowledge of small-molecule drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles
  • Track record of success with clinical development phases
  • Prior experience with regulatory submission (e.g., IND, NDA and/or BLA) preferred
  • Working knowledge in various modeling techniques and programing preferred
  • Excellent verbal and written communication and organizational skills required with experience working on cross functional teams
  • Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
  • Ability and interest in leading dynamic, multi-disciplined project teams
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