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
- Bioengineered Vaccines
- Cell Therapies
- Monoclonal Antibodies (Conjugated)
- Small Molecule
- Senior Medical Director
- Open to remote and travel
- 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