Director/Senior Director, Clinical Development (MD)

Axsome Therapeutics, Inc.; New York (NY); On-site; USD 240,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Significant equity

Generous benefits package

Job summary

Axsome Therapeutics, Inc. is looking for a Director/Senior Director of Clinical Development to lead CNS program initiatives from IND through regulatory submission. This New York-based role requires a minimum of 10 years of clinical research experience and knowledge of CNS indications. The expected salary ranges from $240,000 to $300,000, along with a competitive benefits package. The chosen candidate must work on-site at least three days a week, collaborating closely with cross-functional teams.

Qualifications

• At least 10 years of clinical research experience.
• 4-6 years in a relevant CNS indication.
• Strong communication and project management skills.

Responsibilities

• Provide leadership on protocol development and regulatory submissions.
• Serve as a Clinical Development representative with regulators.
• Collaborate with cross-functional departments for study execution.

Skills

Clinical research experience

CNS indication knowledge

Leadership in clinical development

Communication skills

Project management

Education

Post-graduate degree (e.g., PharmD, PhD) or MD

Job description

Company Overview

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 developing 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, migraine, and multiple late‑stage development programs addressing serious neurological and psychiatric conditions that impact over 150 million people in the United States.

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

The role is based at Axsome’s HQ in New York City with an on‑site requirement of at least three days per week. Candidates seeking fully remote roles will not be considered.

Job Responsibilities and Duties

• 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 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 tracking product / project deliverables
• Champion and facilitate program team meetings, cross‑functional communication, and decision making, ensuring alignment with internal and external stakeholders
• Partner with the Clinical Operations Study Team to oversee the execution of clinical studies
• May serve as lead Medical Monitor on clinical studies (if MD) or assist Medical Monitor with review of subject eligibility
• May contribute to pharmacovigilance monitoring of AEs, SAEs, and FDA reporting and database reconciliation
• Participate in clinical data review at the patient level and in aggregate to ensure quality and integrity of study data
• Train clinical study team on therapeutic area, drug product, and protocol, as needed
• Lead or contribute to publication planning, authoring and presentation of abstracts, posters, slides, and manuscripts
• Author, review, and revise Standard Operating Procedures (SOPs), as needed
• Supervise or mentor other Clinical R & D team members

Requirements / Qualifications

• Post‑graduate degree (e.g., PharmD, PhD) or MD required, with at least 10 years of clinical research experience
• At least 4‑6 years working in a relevant CNS indication
• Knowledge of GCP, ICH guidelines and other local guidance, regulation, and codes of practice related to clinical research
• Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies that lead to obtaining results
• Proven experience in conducting and managing clinical programs (Phase I‑IV)
• Demonstrated ability to effectively communicate with and influence individuals at all levels of the organization, including conflict resolution and problem solving
• Knowledge of the drug development process with strong understanding of other functions relevant to the position, including clinical operations, biostatistics, and regulatory affairs
• Experience supporting meetings with regulatory agencies (e.g., FDA, EMA)
• Willingness to travel as needed
• Ability to work on site Monday, Tuesday & Thursday; fully remote candidates will not be considered

Experience and Knowledge

• Strong time management skills and ability to effectively manage multiple competing priorities
• Strong interpersonal and communication skills (written and oral)
• Self‑motivated, adaptable to a dynamic environment
• Comfortable multi‑tasking in a fast‑paced small company environment and able to adjust workload based on changing priorities

Salary and Benefits

The anticipated salary range for this role is $240,000 - $300,000. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Equal Employment Opportunity

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.