Medical Director Health Services - Cambridge, MA, United States - Precision Life Sciences

Description

Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.

Review data at a patient level, work on the strategy and execution of narrative development, and provide feedback on the SAP.

Serve as medical monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data integrity, in close collaboration with the CRO medical monitor.

As appropriate, provide medical expertise for interactions with regulatory authorities, including required regulatory documentation and responses to questions from global regulatory agencies.