- Medical Affairs Strategic Plans: Work with key stakeholders, management, and functional area leads to develop strategic and aligned Medical Affairs Plans for the therapeutic area. Communicate and represent these plans to upper management/senior leadership within ESI. Continuously update plans and inform stakeholders of progress.
- Phase IV
- Serve as study director for trials: Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas
- 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.
- Board Certified in therapeutic area and US fellowship training, or MD with 2-4 years' experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 5 years' experience within the pharmaceutical industry, including experience in the therapeutic area and 3 years in an in-house Medical Affairs role; MD preferred
- Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area.
- Expertise in Neurodegenerative Disease; especially Alzheimer's Disease
- 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.
- Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise products
- Understanding Medical Affairs activities
- Understanding of Marketing concepts/strategies
- Knowledge of the pharmaceutical marketplace
- FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area
- Knowledge of regulatory guidance regarding marketing/sales promotional materials
- Strong overall written and verbal communication skills
- Must have requisite skills to function in a complex and dynamic environment, including flexibility and ability to negotiate
- CMJE guidance/general publication practices
- Current ACCME guidelines
- Sound computer skills including Microsoft Word, and PowerPoint
- Familiarity with statistical methodology
- PhRMA Code
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Medical Director, US Medical Affairs, Neurology - Nutley, United States - Eisai US
Description
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.
The Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area.
This role is responsible for working with key stakeholders to develop and execute the medical affairs plan, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan.
The Medical Director provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area.
The Medical Director utilizes expert medical/scientific knowledge in assigned therapeutic area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit feedback and strengthen Eisai's medical reputation in the disease state community.
The Medical Director is responsible for approval of medical and scientific content of all relevant materials/communications.Essential Functions:
Clinical Studies:
Direct and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for protocol development, interpretation of trial results, final study report conclusions and publications.
Medical/Scientific subject matter expert:
Serve as medical leader and subject matter expert providing direction for assigned products including (but not limited to) CRC, scientific communications, publication planning/review, advisory boards, health outcomes plans, MSL 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.
Requirements:
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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.
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