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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
- Oncology & Immuno-Oncology
- Infectious Diseases
- Inflammation
- Rare Diseases
Product Technologies
- Protein Therapeutics
- Biologics
- Gene Therapies
- Monoclonal Antibodies
- Small Molecules
- 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.