Senior Clinical Project Manager
17+ years experience as a Phase I-IV Global Clinical Project Manager for biotech and pharma companies. Expertise includes managing multiple studies, global, cross functional teams, budget, and timelines, mentoring direct reports to support job growth and success, vendor/CRO selection and management, and ensuring site compliance with protocol and adherence to GCP. Specialized in study start up activities. Hired and managed clinical operation teams. Has worked on 8 different drug approvals. Extensive audit preparation and experienced successful FDA and EMA audits.
Relevant Therapeutic Areas
- Allergy
- Dermatology
- Infectious Diseases
- CNS
- Ophthalmology
Product Technologies
- Biologics
- Bioengineered Vaccines
- Vaccines
- Cell Therapies
- Small Molecules
Recent Titles
- Associate Director, Clinical Operations
- Senior Clinical Project Manager
Location
- Bay Area
- Open to remote, in-office, and travel
Relevant Companies
- Genentech
- Gilead
- Medivation
- Small & Medium-Sized Biotechs
Skills & Accomplishments
- Has successfully brought 8 different drugs to market.
- Has successful experience with several EMA and FDA audits.
- Extensive experience in oncology and infectious diseases along with Fast Track indications, Rare Indications, and Pediatrics.