My biotech client is expanding and is actively recruiting for a Medical Director for clinical development. The ideal candidate will take on the following tasks:
- Create clinical development plans including translational, biomarker, and immuno-response assessment studies, and implement properly approved clinical protocols.
- Design scientifically rigorous and cost-effective clinical development programs.
- Serve as the medical monitor to assess study progress and resolve all clinical issues that might arise from implementation of corporate-sponsored clinical trials.
- Lead the analyses and data evaluation process to report progress and present to senior management.
- Support clinical development strategic planning activities and translate strategic decisions into actionable plans.
- Prepare and review statistical analysis plans, clinical study protocols, clinical study reports, NDA, BLA and IND summary documents, Safety and Annual reports.
- Respond to regulatory agencies according to FDA and ICH guidance and standards.
- Manage safety monitoring in clinical studies and manage pharmacovigilance and drug programs.
- Ensure the clinical development program requirements and timelines are met.
The ideal candidate will be an MD in Hematology or Oncology and possess 5+ years industry experience in clinical trials and immunotherapies.