Senior Director, Clinical Development

JOB SUMMARY

Axsome Therapeutics is seeking a Director of Clinical Development. The Director of Clinical Development is responsible for leading the clinical program for one or more product candidates within a specific therapeutic area (psychiatry or neurology). This role will act as the Clinical Program Lead for the assigned product candidates including product planning and life cycle management.

JOB RESPONSIBILITIES

• Lead the creation of and 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
• 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
• Contribute to pharmacovigilance monitoring AEs, SAEs, and FDA reporting and database reconciliation
• 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
• Additional responsibilities as assigned

QUALIFICATIONS

• Post-graduate degree required, science-focused qualifications strongly preferred, e.g., MS., PharmD, PhD, with at least 10 years of clinical research experience
• Strong understanding of the drug development process up to and including clinical trial initiation and execution (IND submission through Ph 4 studies)
• Experience in preparing and submitting INDs and (s)NDA
• Strong analytical and problem-solving skills with excellent communication (both oral and written)
• Experience writing clinical documents (eg, protocols, CSRs, IBs,) and regulatory documents (eg, INDs, briefing books, NDAs)
• Thorough understanding of FDA, GCP and ICH guidelines
• 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”
• Willingness to travel as needed, up to 20%
• Ability to work on site Monday, Tuesday and Thursday

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.