Full-Time

Senior Director

Clinical Development, Early Phase

Updated on 5/17/2024

Axsome Therapeutics Inc

Axsome Therapeutics Inc

501-1,000 employees

Develops therapies for central nervous system conditions

Biotechnology

Senior

New York, NY, USA

Required Skills
Communications
Requirements
  • 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
Responsibilities
  • 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

Axsome Therapeutics Inc

Axsome Therapeutics Inc

View

With a dedicated focus on developing therapies for central nervous system conditions—such as depression, Alzheimer’s disease agitation, and fibromyalgia—this company stands out by addressing critical unmet medical needs with promising products like AXS-05 and AXS-07. The firm fosters a culture deeply committed to innovation and the development of therapies with novel mechanisms of action, showcasing strong potential in the medical field and enhancing patient care in areas with limited treatment options.

Company Stage

IPO

Total Funding

$430.7M

Headquarters

New York, New York

Founded

2012

Growth & Insights
Headcount

6 month growth

17%

1 year growth

43%

2 year growth

274%