Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). As our Medical Director, you will support the ongoing and planned execution of the ALS trials and contribute to new indication selection and clinical development planning for Neurology.
Requirements
- Act as a clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
- Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
- Design, develop and, implement clinical studies for the applicable drug candidate, from Phase I through Phase III
- Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
- Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
- Acts to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
- Play a key role in the analysis, interpretation and delivery of high quality clinical data
- Interact with principal investigators and opinion leaders to facilitate clinical trials research
- Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
- Participate in clinical study report conceptualization, development and writing for global regulatory submissions
- Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
- Develop and give internal and external presentations as subject matter expert for the therapeutic area
- Participate in the development and review of publications
- Prepare and monitor budgets in collaboration with clinical operations and R&D finance
- Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.
- Serve as liaison to the commercial team on medical issues
