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.