Director/Senior Director, Clinical Development (MD)

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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 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 wi

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