The Medical Director (MD) will guide key clinical activities across one or more development programs, and lead strategic planning activities for a study or suite of studies. The MD will also assume medical monitoring responsibilities, as needed, across studies and/or development programs.
There is flexibility within a growing company in terms of roles and responsibilities. The MD will need to be able to work seamlessly with the VP Clinical Development (based in SF) to divide and conquer tasks as they arise. The MD will also play an important role in the development of new processes and procedures within Clovis Oncology Clinical Development as the scale and scope of our Development teams continues to grow.
A particularly important area of focus will be close engagement with the Translational Medicine and Molecular Diagnostics teams, based in San Francisco, to enable clinical development of rucaparib (and potentially other assets) in patients identified for treatment by biomarker selection. The MD must have particular enthusiasm for building on and developing the existing strong collaboration with those groups.
- Contribute to the medical management of studies and/or development programs
- Assume clinical leadership of one or more development programs
- Within any study or development program:
- Build strong relationships, based on mutual respect, with the clinical investigators to ensure that clinical studies run safely and efficiently
- Be the internal medical expert. Educate colleagues, site staff and CRO personnel on the medical aspects of the relevant indications.
- Develop a key opinion leader network. Use the network to populate advisory boards, to serve as investigators and as a source of day to day state of the art advice to enrich the programs.
- Develop strategies for robust clinical assessment of an asset in order to reach critical go/no go decisions and advance an asset to the next stage of clinical development
- Work with clinical operations to ensure clinical databases are high quality. This may involve detailed, systematic review of data listings, data tables, and patient profiles
- Author/contribute to key clinical documents, including protocols, investigator brochures, and clinical study reports, as well as regulatory documents, including clinical sections of briefing documents, submissions (IND, NDA, MAA, etc)
- Participate in regular review and interpretation of adverse event and other safety data
- Represent Clovis Clinical development as a clinical team member for one or more studies or development programs
- Conduct review/due diligence of new in-licensing opportunities