At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Job Summary
Assists in the development of medical affairs strategy, planning and supportive tactics for Sleep Disorders.
Under the direction of the Vice President, USMedical Affairs, is responsible for working with key stakeholders to execute the medical affairs plan, including post-marketing research, congress management, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan. Leads theUS strategic development, planning, implementation, and oversight of Phase I through IV clinical trial programs and early new product development within the Medical Affairs department for assigned product(s).
Utilize expert medical, clinical and scientific knowledge in assigned therapeutic area to provide tactical input for the development of product strategies. Maintain relationships with external stakeholders to solicit feedback and strengthen Eisai's medical reputation in the disease state community.
Responsible for review and approval of medical and scientific content of all relevant materials/communications.
Essential Functions
Medical Affairs Strategic Plans: Under the direction of the Director, Medical and Regulatory Affairs, work with key stakeholders, management, and cross-functional area leads to implement Medical Affairs Plans for assigned product(s). Continuously ensure tactical alignment with plans and inform stakeholders of progress. Liaise with MSL & Medical Affairs team.
Clinical and New Product Development: Lead early efforts for new product opportunities in partnership with cross functional area leads. Maintain constant awareness of competitor situations and conduct situational analyses to inform management of opportunities with appropriate lead time. Liaise with Global and US Clinical Development to ensure earlyinvolvement for all Eisai molecules. Liaise with Global and US Clinical Operations and external research partners to ensure smooth and efficient operations with investigators. Participate in the design strategies, planning and implementation of Phase I through IV clinical development programs for assigned product(s). Provide medical input for protocol development, interpretation of trial results, final study report conclusions and publications. Serve as study director for trials. Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas. Working with investigators to facilitate the process for Eisai-sponsored and investigator initiated study clinical trials.
Medical and Clinical Sciences Expert: Serve as medical resource and subject matter expert providing direction for assigned product(s) including (but not limited to) CRC, scientific communications, publication planning/review, advisory boards, health outcomes plans, MSL team and activities, speaker programs, investigator-initiated research and CME grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. Teaching, coaching & mentoring new hire and/or less experienced MSLs.
External leadership: Provides leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. Maintains external orientation by participating actively in external events and activities. Strengthen Eisai's medical reputation through successful management of medical dimensions of products. Working with key professionals at the regional and national level, educating key healthcare professionals with current medical, scientific and pharmaeconomic information on Eisai's products and therapeutic areas.
Congress Management: Lead and/or actively participate in the planning of congress plans. Liaise with Global & US congress leads to coordinateUS Medical involvement at Global & US congresses. When necessary, travel to Medical Conferences, AdvisoryBoards,MSL training and Sales training meetings.
Requirements
PhD or PharmD with 3-5 years experience inNeuroscience area, preferably SleepDisorderswithin the pharmaceutical industry in a US Medical Affairs capacity
Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area. Experience reviewing promotional materials from a medical perspective, publications planning, relevant medical society membership and track record of active participation/attendance, and strong presentation skills.
Experience working with cross-functional medical and commercial teams.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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