Seasoned DMPK Leader

PhD senior scientific leader with 25+ years of experience in the Pharma/Biotech industry. A recognized leader in pharmacokinetics, bioanalysis, analytical chemistry, purification, and formulation development. Has taken multiple small molecule programs from preclinical DMPK/Safety studies to IND filing, including study design/data interpretation, CRO identification/management, and IND section authoring.

Over the years, has maintained a sound track record of achievements in discovery and preclinical development. Has strong interpersonal, leadership, and technical skills with a history of successfully achieving objectives, leading teams, and developing people.

Relevant Therapeutic Areas

  • Rare Diseases
  • Oncology & Immuno-Oncology
  • Infectious Diseases
  • Inflammation

Product Technologies

  • Small Molecules
  • Protein Therapeutics
  • Biologics
  • Gene Therapies
  • Monoclonal Antibodies
  • Drug Delivery

Recent Titles

  • Head of DMPK & Analytical Sciences
  • Director, DMPK

Location

  • Greater Boston Area
  • Open to remote and in-office

Relevant Companies

  • Abbott
  • AstraZeneca
  • Millennium
  • Small Biotechs

Skills & Accomplishments

  • Design of in vitro ADME and PK studies, interpretation of data and integration of learnings into the overall program. Work with CROs to generate key data to fill a documentation gap or solve specific problems.
  • Translational support through the design and execution of IND-enabling studies. Activities include study design, CRO selection/oversight, data interpretation, and document preparation.
  • Management of multiple projects with aspects of methods development/qualification for content and stability-indicating methods. Support GMP production, training of laboratory personnel, and ongoing troubleshooting. Assessment of regulatory data to address Agency questions for IND submission.