Clinical Development Program Leader

A company is looking for a Sr. Director Clinical Development / Program Leader.

Key Responsibilities

Oversee the planning, execution, and delivery of clinical studies from Phase 1 through NDA submission

Provide clinical leadership, ensuring scientific rigor, patient safety, and data integrity

Collaborate with cross-functional teams to ensure compliance with GCP and regulatory standards

Required Qualifications

M.D., Ph.D., or equivalent advanced degree in a relevant discipline

5+ years of experience in clinical development within the biopharma industry

Proven track record in designing and executing clinical programs in psychiatry or relevant indications

Prior involvement in FDA or EMA meetings supporting clinical development

Deep understanding of clinical trial operations and regulatory expectations for pivotal programs