Senior Director, Clinical Development (Early Phase)

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City. 

About This Role 

Axsome Therapeutics is seeking a Senior Director of Clinical Development for late phase studies in Phase 2-4. The incumbent is responsible for leading the clinical program for one or more product candidates within a specific therapeutic area (psychiatry or neurology) for early phase studies. This role will act as the Clinical Program Lead for the assigned product candidates including product planning and life cycle management. This role reports to the Executive Director, Clinical Development. 

This role is based at Axsome’s HQ in New York City. 

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

• Lead the creation of/provide scientific insight into study designs and disease area strategy 
• Oversee or lead protocol development, Investigator’s Brochures, annual regulatory reporting, and clinical study reports 
• Work in close collaboration with regulatory and CMC to develop and execute program strategies from IND through all phases of clinical development 
• Engage Key Opinion Leaders for innovation approaches to study design and drug development 
• Evaluate external product labels and scientific literature for study design, competitive landscape, and strategy development 
• 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 Study Team to oversee the execution of clinical studies 

• Provide scientific insight into study design and disease process 
• Train clinical study team on therapeutic area, drug product, and protocol, as needed 
• Oversee or contribute to Clinical Study Reports (CSR), and clinical sections of INDs and NDAs (Module 5) 
• Drive and present abstracts, poster presentations, slides, and manuscripts of clinical study findings 
• Author, review, and revise Standard Operating Procedures (SOPs), as needed 
• Lead/contribute to publication planning, authoring and presentation of abstracts, posters, slides, and manuscripts 
• Assist Medical Monitor with review of subject eligibility 
• Provide input into pharmacovigilance strategy 
• Participate in data review of clinical and safety measures at the patient level and in aggregate to assure subject safety and efficient study conduct 
• Supervise or mentor other Clinical R & D team members 

 Requirements / Qualifications 

• Post-graduate degree required, science-focused qualifications strongly preferred, e.g., MS., PharmD, PhD, MD  
• 8-12 years of clinical research experience 
• Previous experience in a CNS indication and oversight of efficacy studies is required 
• Willingness to travel as needed, up to 20% 
• Ability to work on site Monday, Tuesday & Thursday 

 Experience and Knowledge 

• Strong understanding of the drug development process up to and including clinical trial initiation and execution (IND submission through Ph 4 studies, expertise in efficacy and indication-related studies) 
• Experience in preparing and submitting INDs and (s)NDA 
• Experience writing clinical documents (e.g., protocols, CSRs, IBs,) and regulatory documents (e.g., INDs, briefing books, NDAs)  
• Thorough understanding of FDA, GCP and ICH guidelines 
• Strong analytical and problem-solving skills with excellent communication (both oral and written)  
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities 
• Excellent team player: willingness and ability to fill functional gaps in a small but growing organization 
• Preference to energetic candidates with a desire to think “outside the box” 

 Salary & Benefits 

The anticipated salary range for this role is $245,000 - $260,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. 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. 

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