Location
Cambridge, MA | United States
Job description
Opportunity: Medical Director
Job 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.
- Provide study leadership and collaborate with cross-functional team members across the lifecycle of the study (i.e., design, execution, interpretation, and communication).
- Support Clinical Lead for the program.
- Data review at a patient level, and work on 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.
- Build and maintain strong relationships with clinical investigators .
- Effectively fosters productive and collegial working relationships in a cross-functional, matrix environment with internal and external stakeholders.
Job tags
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