Full-Time
Senior Director
Clinical Development, Early Phase
Updated on 5/17/2024
Develops therapies for CNS conditions
Senior
New York, NY, USA
- 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
- 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 is dedicated to the development of groundbreaking therapies for central nervous system conditions, focusing on addressing the often underserved needs in depression, Alzheimer's disease, and other related disorders. With its commitment to unique mechanisms of action, this company provides a compelling work environment for those passionate about making a significant impact in healthcare. Employees at Axsome engage in pioneering work, driving the advancement of new treatments that promise to enhance patient lives significantly.
Company Stage
IPO
Total Funding
$430.7M
Headquarters
New York, New York
Founded
2012