Seasoned Global Clinical Development Leader
MD, PhD with 25+ years of experience in the pharmaceutical industry where, as a translational scientist and clinical drug developer, have successfully led multiple cross-functional teams and departments in bringing various NCEs to commercialization.
Has directly and indirectly provided support to more than 40 NDAs, BLAs, MAAs, ANDAs, and INDs, and has published more than 80 papers, abstracts, reviews, and book chapters. Board certified and practicing endrocinologist in parallel during pharmaceutical career.
Relevant Therapeutic Areas
- Metabolic Diseases
- Cardiovascular Diseases
- Cell Therapies
- DNA & RNA Therapeutics
- Gene Therapies
- Monoclonal Antibodies
- Small Molecules
- Chief Medical Officer
- Vice President, Clinical Development
- Greater Philadelphia and Washington DC areas
- Open to remote and in-office
- Novo Nordisk
- Small Biotechs
Skills & Accomplishments
- Strategy: Nonclinical-translational-clinical-regulatory (global)-operational-medico-marketing product launch strategy; product development plan; business plan; communication/publication plan; target product profile; portfolio assessment/pipeline prioritization (including due diligence).
- Key meeting preparation/negotiations: Trial investigator meeting; IRB/IBC/EC; pre-IND; EOPI; EOPII; scientific advice; PDCO; pre-submission; FDA Ad com; and ex-US country regulatory CTA meetings.
- Key document writing and assembly: Protocol; investigational brochure; informed consent; clinical trial brochures/charters; CTR; FDA/EMA designations (fast track, rare pediatric, orphan, RMAT, etc); nonclinical/clinical sections of IND/CTA/BLA/NDA/ ANDA/MAA and other regulatory submissions.
- Lead key external engagements: Investors; KOLs; regulators; scientific advisory board; scientific and medical societies; patient advocacy; trial safety committees