Location: New York, NY
Director Level/VP, Medical Affairs
Axsome Therapeutics is currently searching for a Senior Director, Medical Affairs.
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders.
The Axsome team is comprised of a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders.
Axsome is based in New York City, New York.
The role is responsible for the development of strategy and execution of tactics in support of medical affairs across several CNS therapeutic areas relevant to Axsome’s broad product pipeline. These therapeutic areas include depression, Alzheimer’s disease, migraine, narcolepsy and fibromyalgia.
- Lead the strategic design and execution of the Medical Affairs (MA) plan in alignment with the brand strategy
- Support the building out of Axsome’s medical science liaison capability
- Develop focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies
- Develop medical affairs objectives, and design strategies and tactics in support of these objectives
- Strategic input into pre-, peri- and post-launch medical affairs activities in support of drug approval and commercialization
- Design and implementation of a publication plan for relevant therapeutic areas and drug products
- Interpret and communicate results of Phase I-IV investigations in preparation for potential new drug approvals
- Identify evidence gaps in the scientific community and propose evidence generation opportunities (clinical trials, surveys and educational events) to address these gaps
- Develop and maintain key opinion leader (KOL) relationships
- Coordination, planning and execution of advisory boards
- Liaise with and act as corporate representative to relevant professional scientific organizations, patient advocacy groups and charities
- Support regulatory strategy in the form of strategic discussion, document drafting and review, and ensure all medical affairs activities follow appropriate regulatory guidance and requirements
- Have oversight over the regulatory Review Committee (RC) participating in the review and approval of externally directed medical and commercial materials
- Partner with the internal commercial development group on distillation of scientific data into key messaging and communications
- Support the review and writing of clinical, medical, or regulatory documents as required
- Advanced degree: MD (psychiatrist or neurologist a plus), PhD or PharmD with relevant CNS experience
- A minimum of six years’ experience in the pharmaceutical industry in clinical development, Medical Affairs or other related functions, preferably in CNS
- A thorough knowledge of clinical medicine and science management is required. This entails defining critical objectives clearly and maintaining focus toward achieving business outcomes on time, on budget and with superior quality
- Demonstrated experience leading, managing and motivating team members (e.g., internal staff and external investigators or consultants)
- Dedication to assigned, developed projects and project goals is necessary. This includes an appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting
- Willingness to travel 30% of time, over weekends and ability to travel internationally
- An advanced understanding of drug development principles and clinical trial is essential and will be further developed, including:
- Flexibility in working across different therapeutic areas and experience in different stages of clinical development
- Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing
- Complete understanding of the global regulatory requirements: demonstrated experience in successful regulatory filings, while not essential, is an advantage
- Exceptional communication skills (written and verbal) as evidenced by a demonstrated ability to prepare complex documents and publications and to give presentations, specifically:
- Proven ability to design, interpret and communicate clinical phase studies
- Ability to interpret scientific and clinical trial data and present that information in different formats for appropriate audiences
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Strong interpersonal skills
- Preference to energetic candidates with a desire to think “outside the box”
- Thorough knowledge of company policies and processes
- Must be able to work in the NYC office