Location: New York, NY
Reports to: Executive Director, Clinical Research
Associate Director, Clinical Operations
Axsome Therapeutics is currently searching for an Associate Director, Clinical Operations (AD) to lead one, or more, of our clinical studies. We are a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. By focusing on this therapeutic area, Axsome is addressing growing markets where current treatment options are limited or inadequate. Axsome has a balanced portfolio of clinical development stage as well as research stage products. Axsome is located in New York City, New York.
Leads clinical operations for assigned clinical program(s) including oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables. Manages, mentors, and provides professional development guidance to clinical trial managers (CTMs), clinical research associates (CRAs), and clinical trial associates (CTAs).
- Operational oversight of one or more clinical development programs. Plan and initiate clinical trials including protocol development; evaluation of investigators; evaluation, selection and training of vendors; review and negotiation of study budgets; CRF design coordination; Direct the planning and execution of all operational activities involved in area of specific therapeutic indication.
- Leads cross functional teams at the program and study levels
- Ensures clinical studies/programs are executed within projected budget, on time and with quality
- Guides study team in vendor selection and management throughout the life of all assigned clinical projects
- Determines patient recruitment strategies, operational feasibility and implementation of study objectives
- Manages and communicates to senior management overall clinical operations plan for projects including timelines, internal and external resources/costs, and key deliverables
- Plans, convenes, runs and presents at investigator meetings and advisory boards
- Identifies and communicates with therapeutic thought leaders for feedback on study protocols, development plans, publications, etc.
- Negotiating site budgets; develops and manages study specific timelines
- Identifies and provides solutions and direction related to key cross-functional, sponsor-site, and sponsor-vendor clinical trial issues
- Authors, reviews and revises Clinical Operations Standard Operating Procedures (SOPs)
- Hire, supervise and train operations personnel (CTM, CRAs, and/or CTAs) and takes ownership of the quality of assigned clinical programs and deliverables. Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations
- Bachelor degree required. Preference to candidates with a scientific background (RN, MS, MD, PharmD, PhD or similar).
- At least 7 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO). At least 1 year clinical research experience at a biotech/pharmaceutical company is required. Preference to candidates with prior small company experience.
- Must be able to work in the NYC office.
- Thorough understanding of FDA, GCP and ICH guidelines.
- Must have strong organization skills, be a team player yet function independently and comfortable interacting with KOLs, vendors and investigational sites.
- Adept at developing clinical study patient recruitment strategies
- Exhibits strong presentation skills.
- 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%.