Seasoned Global Clinical Development Leader
MD with 25+ years as a clinical development expert, which multiple experiences as CMO and VP of Clinical Development at small to large companies. Has many examples of successful clinical development leadership and strong experience in interacting with the FDA, providing clinical development plans from early-stage to first in human and proof of concept.
Has authored and edited many documents for the FDA (position papers, IND sections, and an NDA) and have been to face-to-face discussions with FDA and EMA regulators a number of times. Has had major roles in two drug approvals.
Relevant Therapeutic Areas
- Endocrinology & Metabolic Diseases: Type 2 diabetes, obesity
- Rare Diseases: Transthyretin polyneuropathy, primary sclerosing cholangitis
- CNS: Huntington’s Disease
- Immunology & Inflammation: Cytokine release syndrome, SARS-Co-V2 inflammation, type 1 diabetes, rheumatoid arthritis, transplant immunology & graft vs. host disease
- Gene Therapies
- Monoclonal Antibodies
- Small Molecules
- Chief Medical Officer
- Senior Vice President, Clinical Development
- San Francisco Bay Area
- Open to remote and in-office
- Johnson & Johnson
- Small/Medium Biotechs
Skills & Accomplishments
- Designed and executed Phases I through IV clinical trials, including first-in human, proof-of-concept and registrational trials.
- Has negotiated regulatory pathways with global Health Authorities, including FDA and EMA for preIND, IND, end-of-phase 2 and NDA submissions, and has secured agreements with FDA for an accelerated approval development path.
- Accountable for recruiting of investigators, authoring of clinical sections of key documents, as well as providing scientific and medical expertise to the development team