1-617-500-6690 [email protected]

Company:  Confidential

Job Title: Director, ADME/PK

Job Number: 30382

Location: 1560 Trapelo Rd Waltham, MA 02451

Job Description

The Director, ADME-PK will be a key member of 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 portfolio programs.  These activities will support 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 apply various approaches and strategies to predict human PK parameters from analysis of nonclinical data and assess PK/PD properties of drug candidates based on preclinical data. The incumbent will author clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures (IB).

Responsibilities

  • Represent PCD as subject matter expert (SME) providing expertise and guidance on ADME-PK on discovery and program teams
  • Design and oversee internal/external discovery and PCD ADME-PK studies to understand ADME-PK 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
  • Collaborate with Clinical Pharmacology/Pharmacometrics to develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation (M&S)
  • 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

Required Skills

  • 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
  • Demonstrated expert level strategic and functional application of quantitative system pharmacology
  • Hands-on skills in modeling and simulation using Phoenix/WinNonlin, Berkeley Madonna, NONMEM, R, and other systems
  • Other aspects, comprising strong interpersonal and collaboration skills, familiarity with 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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