Medical Director/Sr Director, Clinical Research
Scholar Rock, Cambridge, MA
What you will do
- Provide medical leadership for clinical development activities of assigned pipeline products, including leading efforts to define clinical development strategy and plan
- Collaborate with other members of the development and research teams to contribute to building a collaborative culture and improving effectiveness of the development team
- Serve as subject matter expert, leading efforts to provide scientifically robust evaluation of development strategy and plans, including robust literature review to perform disease area assessment, development landscape analysis, and development and regulatory pathway evaluation
- Engage with external scientific and clinical trial experts, clinical and regulatory consultants, to develop scientifically robust clinical study design
- Provide hands-on authoring of clinical and regulatory documents, including study concepts, protocols, investigator brochures, regulatory documents, publications, etc.
- Serve as lead author in clinical responses to regulatory authorities, related to review of protocols, INDs, BLA/MAA/JNDA, and other regulatory filings