Job Description:

Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. This position will fill an open vacancy while an FTE is hired.

• 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 throughout the study's lifecycle (i.e., design, execution, interpretation, and communication).
• Support Clinical Lead for the program.
• 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.
• 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.

 

Posted On: Tuesday, April 16, 2024