Senior Medical Director

Description:

An established gene therapy innovator is seeking a Senior Medical Director, CNS to join its remote team based on the East Coast. The company boasts a robust and diverse pipeline across CNS, cardiovascular, and metabolic disease areas and is supported by a major global healthcare group while maintaining independent operations across North America and Europe. It fosters a culture of scientific innovation, collaboration, integrity, and a strong patient-first mindset.

In this pivotal role, you will be responsible for shaping and executing clinical development strategies with a global lens. You will lead the design, interpretation, and reporting of clinical studies and critical regulatory documents. Your expertise will also be integral in overseeing clinical trial safety, including monitoring, serious adverse event (SAE) assessments, and Data Safety Monitoring Board (DSMB) engagement.

Additionally, you will collaborate with cross-functional teams to ensure robust trial execution, optimal site support, and patient safety. The role includes unblinded safety reviews, support for both internal governance and external regulatory requirements, and ensuring the generation and communication of high-quality clinical data aligned with the company's goals. This is a comprehensive role with wide-reaching impact across the entire clinical development spectrum.

Requirements:

• MD, DO, or MBBS with board certification

• Significant industry experience in CNS clinical research

• Hands-on experience with Phase 2 and Phase 3 trials

• Demonstrated leadership and decision-making ability in clinical development

• Excellent communication and collaboration skills with cross-functional teams