Medical Director or Senior Medical Director (Metabolics)
I'm currently looking for a Clinical Development expert in the Metabolic space, to morph into a therapeutic lead for a growing team that's based in the Bay Area. This role offers a Hybrid work flow so you can enjoy the science from the comfort of your home ut also havethe option to network with impactful indivudals in the space.
Essential Duties/Tasks
- Act as clinical scientist and clinical subject matter expert for 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
- Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs
- 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
- 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
Education Preferences
- MD educated
- Board Certified is a plus but not a must
Helpful Skills & Qualifications
- Medical Monitoring
- Protocal Design
- Familairy in Early Development/ Phase 3