Clinical Operations Leader & Project Manager

Over 10 years of clinical research experience managing industry-sponsored studies across multiple therapeutic areas. Proven track record for ensuring compliance with government regulations such as FDA, TGA, PEI, CBER, EMA, and MHRA through meticulous auditing and quality control. Expertise in implementing global expanded access programs. Demonstrated leadership abilities that are key in providing innovative and efficient solutions in the evolving clinical research space.

Relevant Therapeutic Areas

  • Oncology
  • Endocrinology
  • CNS
  • Pediatrics
  • Rare Disease
  • Hematology
  • Expanded Access/Compassionate Use
  • Devices

Product Technologies

  • Drug
  • Devices

Recent Titles

  • Senior Director, Clinical Operations
  • Director, Clinical Trial Operations & Monitoring


  • Midwest
  • Open to remote and travel

Relevant Companies

  • Astellas
  • Small & Medium Sized Biotechs

Skills & Accomplishments

  • Vendor selection and management, budget negotiation, and oversight of start-up activities.
  • Inspection readiness activities for NDA submissions for global programs across therapeutic areas.
  • Has held several director level positions at mainly small companies and is consequently very hands-on, cross-functional, and a team player.