- Lead tactical execution of the Integrated Evidence Generation Planning Process (IEGP) including RWE and Phase 4 high priority studies
- Plan and execute an integrated medical strategy for assigned products/molecule(s) that addresses current and future needs of the business
- Lead the Medical Core Team meetings (MCT)
- Lead the development of the strategic scientific communication platform(s) aligned with the brand strategy and franchise strategy across lifecycle and molecules
- Monitor and leverage medical insights to support and inform brand strategy
- Work with clinical and commercial partners to support Market Access, Commercial Development, Value and HEOR activities (market research, speaker's bureau, advisory boards, etc.)
- Support the expert engagement plan and overall scientific communication strategy including medical congress content, medical booth, and educational materials development, authorship and review of abstracts and manuscripts
- Guide Independent Medical Education (IME) grants strategy and vetting of medical education providers and their scientific expertise in therapeutic areas of interest
- Oversee CME/grant requests, processes, and progress
- Medical and strategic oversight of company investigator initiated (IITs) trials
- Work with Field Medical functions to establish scientific exchange priorities, disseminate field medical insights throughout the organization, and support regional needs
- Meet all administrative and compliance related activities within policy and on-time
- Assure oversight and management of vendors operationalizing Axsome's medical capabilities
- Develop and track appropriate budget setting, resource allocation and expense monitoring
- Advanced degree (MD, PharmD and/or Doctorate) in neuroscience required, MD desirable
- Neurology / neuroscience experience from working in medical affairs/clinical development is preferred
- Experience in migraine highly desirable.
- Minimum 7 years of relevant experience
- Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles .
- Experience with strategic and tactical planning for pipeline and/or marketed product required
- Experience with strategic evidence and scientific communication planning processes
- Experience leading phase IV, real-world evidence, and other post-marketing studies
- Experience working with field medical teams
- Experience with relevant medical specialists highly desirable
- Strong collaborative, interpersonal and team interaction skills, experience working in a cross-functional team environment and ability to execute a must
- High degree of professionalism, integrity and collaboration required
- Exceptional verbal, written and communication skills
- Ability to travel required (~ 30%)
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
- Thorough knowledge of company policies and processes
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Senior Director, Medical Affairs - New York, NY, United States - Axsome Therapeutics
Description
Company Description
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.
About this role
Axsome Therapeutics is seeking a Senior Director, Medical Affairs responsible for the development of medical strategy and execution of tactics related to the company's strategy for an approved product. This is an expert scientific and medical position focused on providing leadership of core Medical Affairs deliverables such as scientific exchange, evidence generation, cross-functional collaboration, and planning and execution of activities for AXS-07 in migraine. As such, the position will require deep understanding and experience in neuroscience, the role of Medical Affairs, and planning and driving projects.
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties include, but are not limited to, the following:
Requirements/ Qualifications
Experience and Knowledge
Salary & Benefits
The anticipated salary range for this role is $230,000 - $255,000. 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.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
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