Director/Senior Director, Clinical Development (MD)

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.

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 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 also serve as lead Medical Monitor on clinical studies (if MD) or may assist Medical Monitor with review of subject eligibility
• May contribute to pharmacovigilance monitoring 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
• Train clinical study team on therapeutic area, drug product, and protocol, as needed
• Lead/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
• Must have 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 situations of 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, etc.)
• Willingness to travel as needed
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Experience and Knowledge:

• Strong time management skills and ability to effectively manage multiple competing priorities
• Strong interpersonal skills and communication skills (both 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 upon changing priorities

Salary and Benefits:

The anticipated salary range for this role is $240,000 - $300,000. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

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.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.