Director/Senior Director, Clinical Development (MD)

Responsibilities

• Provide Clinical Development leadership on protocol development, overall study/program, and regulatory submissions
• Serve as a Clinical Development representative with external stakeholders such as the FDA and Principal Investigators
• Contribute to the development of clinical and regulatory documents including CSRs, Investigator’s Brochures, and IND/NDA sections
• Collaborate with cross-functional departments to execute program strategies from IND through all phases of clinical development
• Partner with Clinical Operations to oversee the execution of clinical studies
• Lead or contribute to publication planning, authoring, and presentation of abstracts and manuscripts
• Supervise or mentor other Clinical R&D team members

Requirements

• MD, PharmD, or PhD degree
• At least 10 years of clinical research experience
• 4-6 years of experience in a relevant CNS indication
• Proven experience managing clinical programs from Phase I-IV
• Knowledge of GCP, ICH guidelines, and regulatory codes of practice
• Experience supporting meetings with regulatory agencies (e.g., FDA, EMA)
• Ability to work on-site in New York City at least three days per week (Monday, Tuesday, and Thursday)
• Willingness to travel as needed

About the Company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions, focusing on novel mechanisms of action to improve patient outcomes in neuroscience.