Key immediate opportunities include:
- Attending study team meetings with internal teams, CROs and other vendors and providing medical oversight and clinical development guidance.
- Continuing the clinical development activities of our products to best position successful submissions with regulatory agencies.
- Provide medical leadership and design input for all clinical programs.
- Write medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions.
- Medical monitoring support to clinical investigators and internal/external team members (e.g., address medical and eligibility questions related to clinical protocols, answer product candidate related questions).
- Oversee safety for clinical studies (e.g., SAE reporting, ongoing review of events, integrated evaluation) in collaboration with the Drug Safety/Pharmacovigilance team and other external vendors.
- Review and interpret clinical trial data and assisting with preparation of periodic and final study reports.
- Collaborating with the medical affairs team and contribution to the development and review of scientific publications.
- Support preparation of regulatory documents (e.g., IND, BLA, and other regulatory communications).