4 months ago
A clinical- stage biotech with novel oncology platform is looking to build out their Medical Affairs function having received recent FDA fast-track designation. This position reports directly to the Chief Medical Officer
- Trained Medical Doctor M.D., Board certified or elligible in Oncology, Hematology/Oncology, or related fied preferred.
- 5+ years industry experience in clinical development required. Industry pexperience in intratumoral treatments preferred.
- Excellent scientific record with experience in basic cancer research and/or oncology clinical trials within academic institutions or the pharmaceutical industry
- Desire and ability to effectively participate within multi-disciplinary teams.
- Leads medical affairs strategy for oncology pipeline
- Contributes to selection of discovery compounds, design of development strategy and transition of compounds into late phase development.
- Leads the interpretation of clinical results and makes appropriate recommendations in support of the overall strategy.
- Contributes to the writing and review of reports submitted to regulatory agencies.
- Builds relationships with key opinion leaders and principal investigators.
- Contribute to corporate strategic and organizational initiatives.
- Leads and oversees the tactical development and strategic definition of clinical study programs, including protocol writing, interpretation of clinical data, and literature reviews.
- Ensures that all clinical studies are in keeping with approved timelines, with potential obstacles identified and solutions implemented to avoid delays in clinical study execution.