Seasoned Clinical Research & Safety Leader

15+ years of experience in senior medical & clinical safety positions in the biopharma and CRO industries. Providing scientific, medical and safety expertise across multiple clinical projects for Asia-Pacific, Europe and North America and leading Asian Medical and Pharmacovigilance team. Contributing to strategic consulting and advise for clinical development programs, planning, study design and study conduct for phase I to Phase III projects.

Relevant Therapeutic Areas

  • Vaccines: Seasonal flu, avian influenza, bacterial vaccines, cancer vaccines)
  • Oncology & Immuno-Oncology: Lung, breast, colon, cervical, and various solid tumors
  • Infectious diseases: Hepatitis, viral diseases

Product Technologies

  • Bioengineered Vaccines
  • Biologics
  • Cell Therapies
  • Drug
  • Monoclonal Antibodies (Conjugated)
  • Small Molecule
  • Vaccines

Recent Titles

  • Senior Medical Director


  • Open to remote and travel

Relevant Companies

  • Clinipace
  • Covance
  • Small Biotechs

Skills & Accomplishments

  • Oversee the PV/Safety program to provide safety oversight and risk management, including review of SAE reports for phase I to phase III studies.
  • Lead teams for timely regulatory submissions (SUSARs, DSURS, annual reports).
  • Manage 3rd party PV vendor, safety data review for studies and participation in safety meetings.
  • Additional expertise in regulatory study documents development, training and business development; and close collaboration working with other functional teams including regulatory, clinical operations, pharmacovigilance and safety, data management, biostatistics, and medical writing