Director/Senior Director, Clinical Development (MD)

About this role

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role:

Axsome Therapeutics is seeking a Director/Senior Director, Clinical Development to provide leadership across the full lifecycle of CNS programs, from IND through late-stage development and regulatory submission. The Director/Senior Director, Clinical Development will help shape clinical strategy, contribute to protocol design and key regulatory and clinical documents, and serve as a clinical representative with regulators, investigators, and cross-functional partners.

This position will work closely with Clinical Operations, Regulatory, Biostatistics, Medical Affairs, HEOR, and Commercial teams, and will support high-quality study execution, data review, and program decision-making, while ensuring alignment with GCP and global regulatory standards. This role also contributes to regulatory interactions, publication planning, and mentorship within a fast-paced and collaborative environment.

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Job Responsibilities and Duties include, but are not limited to, the following:

• Provide Clinical Development leadership on protocol development, overall study/program, and regulatory submissions

• Serve as a Clinical Development representative with external stakeholders (e.g., FDA, Principal Investigators, and site staff)

• Contribute to the development of clinical and regulatory documents, including Clinical Study Reports, Investigator’s Brochures, annual reports (e.g., DSUR), briefing books, and clinical sections of INDs and NDAs

• Review and contribute to the development of the Statistical Analysis Plan

• Work in close collaboration with cross-functional departments (e.g., regulatory, clinical operations) to develop and execute program strategies from IND through all phases of clinical development

• Collaborate with Medical Affairs, HEOR, and the Commercial team to develop the Target Product Profile and overall Value Proposition

• Develop timelines and integrated program plans for the tracking of product / project deliverables

• Champion and facilitate program team meetings, cross-functional communication…