Medical Director - Cambridge, United States - Precision Life Sciences

Precision Life Sciences
Precision Life Sciences
Verified Company
Cambridge, United States

1 month ago

Mark Lane

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Mark Lane

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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 crossfunctional 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 crossfunctional, matrix environment with internal and external stakeholders.
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