30+ years of pharmaceutical discovery research and nonclinical drug development experience in industry and contract research organizations (CROs) with proven expertise in nonclinical sciences and regulatory strategy across multiple therapeutic areas including CNS, Infectious Diseases, Inflammation, and Oncology. Broad discovery, developmental research, and regulatory expertise with Small Molecule, Generics, Biologics, MAbs, ADCs, Biosimilars, Nucleic Acid/Gene Therapies, Cell Therapies including CAR-T, Vaccines, Recombinant Proteins, Peptide Products, and Repurposed Drugs
Extensive experience writing and review of CDER and CBER submissions, including INDs and BLAs; various meeting packages including INTERACT, Pre-IND, EOP2A, and Pre-BLA; Investigator Brochures, PDEs, and ICH M7-related analyses. Experience with OTAT and RMAT review and interactions.
Relevant Therapeutic Areas
- Cardiovascular Diseases
- Infectious Diseases
- Metabolic Diseases
- Small Molecules
- Gene Therapies
- Cell Therapies
- Director, Toxicology, Drug Safety and Metabolism
- Senior Director, Scientific Operations
- West Coast
- Open to remote, travel, and in-office
- Charles River Labs
- Small Biotechs
Skills & Accomplishments
- Familiarity with guidelines and submissions across regulatory jurisdictions other than FDA.
- Designs non-clinical programs and analyzed gaps in pre-existing programs, especially for novel small molecules, MAbs, ADCs, biosimilars, recombinant proteins, vaccines, gene/cell therapies, radiation mitigants, and repurposed drugs.
- Provides program oversight, CRO site visits, study monitoring, review of data for conformity to appropriate regulatory guidance and GLP-compliance, and reviews nonclinical programs for adequacy to Agency requirements for human study.