Director, ADME-PK

Precision Life Sciences - Waltham, MA

Director, ADME-PK

PRECISION LIFESCIENCES

The Director, ADME-PK will be a key member of the Preclinical Development (PCD) function and be responsible for the strategic planning and execution of in vitro and in vivo pharmacokinetics (PK), absorption, distribution, and elimination (ADME), pharmacokinetics/pharmacodynamics (PK/PD) studies of the company portfolio programs. These activities will support the discovery through first-in-human (FIH) of investigational antibody oligonucleotide therapeutics to treat serious muscle diseases. Working closely with Research, Toxicology, Translational Biomarkers, and Bioanalytics, Clinical, Regulatory, Project Management, and other departments, the successful candidate will be expected to provide expertise in PK and PK/PD study design, protocol development and execution, data analysis, modeling, interpretation, and reporting. The incumbent will author clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures (IB).

Primary Responsibilities Include:

  • Represent PCD as subject matter expert (SME) providing expertise and guidance on ADME-PK on discovery and program teams
  • Design and oversee internal/external PCD ADME-PK studies to understand ADME-PK properties of Fab-oligonucleotide conjugate therapeutics
  • The primary contact to manage, guide, and execute these studies in CROs, ensuring studies are completed to meet program objectives and timeline, and with the quality consistent with regulatory standards and guidelines (FDA, EMA, GLP, and GCP)
  • Responsible for the analysis, interpretation, integration, and reporting of ADME-PK data generated both internally and externally
  • Author high-quality regulatory documents
  • Facilitate strategic scientific communication via meetings, abstracts, and manuscripts
  • Partner with and support Research, Toxicology, Translational Biomarkers, Clinical, Regulatory, Project Management, and other departments

Education and Skill Requirements:

  • PhD in pharmaceutical sciences, pharmacokinetics, or a related discipline with a minimum of 5 years experience working in the pharmaceutical industry
  • Broad and in-depth knowledge in ADME-PK and bioanalytical method development of biopharmaceuticals and/or oligonucleotides
  • Hands-on skills in using Phoenix/WinNonlin for interpreting PK data
  • Other aspects, comprising strong interpersonal and collaboration skills, familiarity with the regulatory submission including FIH dosing strategy, understanding of GLP requirements, and enjoying the collaborative and dynamic biotech setting, are also desirable

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Posted On: Monday, November 21, 2022



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