Essential Job Functions:
- Lead cross-functional clinical teams for the design and conduct of oncology/hematology studies.
- Ensure that scientific rigor and innovation continues to be integrated into and drive copmany’s Oncology’s development strategies.
- Ensure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, data management, program management, and research colleagues.
- Serve as Medical Monitor of sponsored clinical research and as medical representative to CROs, reference laboratories and other organizations involved in the execution of clinical trials.
- Responsible for of all clinical regulatory deliverables and other clinical documents associated with the clinical trials under his/her direct responsibility, including protocols, and the clinical portion of INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s and clinical expert reports, among others.
- Responsible for the analysis of clinical data, including safety monitoring in collaboration with PV.
- Participate in site initiation visits and other site visits at clinical center.
Job Specifications:
- M.D. degree with at least 5 years of relevant experience in drug development either in industry (preferred) or in academia. M.D. Ph.D. degree preferred.
- Proven track record of strong clinical research skills, including publications.
- Ability to partner with others to implement innovative oncology development strategies.
- Experience in precision oncology/hematology preferred.
Job Type: Full Time