Clinical Scientist (Late Stage)
MBX Biosciences, Burlington, MA +1
What you will do
The Clinical Scientist will provide clinical and scientific expertise to deliver clinical studies in early- and/or late-stage development. This individual will be responsible for the hands-on implementation and execution of assigned clinical studies under the supervision of a Director/Senior Director in Clinical Development. This individual will support clinical studies in collaboration with other members of the cross-functional study team. Clinical Pharmacology studies may be in-scope based on company need.
- Provide clinical and scientific oversight of clinical study execution, from start-up to close-out and results reporting.
- Leading role in authoring clinical study protocols/amendments and related study documents (including but not limited to drug specific risk language, ICFs, clinical study training materials, pharmacy manual, laboratory manual, etc.) by translating the strategy and approved concept into executable and efficient clinical studies.
- Contribute to authoring various regulatory study documents, including clinical sections of IND/NDA and CTA submissions, investigator brochures, annual reports and updates, and clinical sections of heath authority responses.