- 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. Continuously update plans and inform stakeholders of progress.
- She/He will lead medical strategy mainly for GU oncology and provide critical medical input into the lifecycle management strategies for that therapeutic area.
- She/He will strategize and execute Phase IV clinical development programs for assigned products.
- Design and review IIS strategies and review proposals in conjunction with company policies, as well as providing critical inputs to review of CME grants.
- She/He will independently provide subject matter expertise and overarching engagement strategy for relevant external (HCPs, strategic alliances etc.) and internal stakeholders of the franchise.
- Provide medical expertise and direction for assigned products on key internal business processes including leading and/or active participation in relevant medical review committees.
- Partner with key internal stakeholders to support development and communication of medical operating plans for the therapeutic area and track progress for reporting.
- Ensure all relevant approvals of medical and scientific content for assigned therapeutic areas and participate actively in external events and activities to incorporate insights from scientific trends and treatment landscape.
- Lead strategic conversations and liaise with external stakeholders to solicit feedback and strengthen Eisai's medical reputation in the disease-state community.
- Direct and manage financial planning/forecasting and budget management, vendor management, timeline development & tracking, and assess resource needs for respective program(s) within scope of work.
- 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.
- MD with 2-3 years' experience in oncology within the pharmaceutical industry including 2 years in-house Medical Affairs role or PhD or PharmD with 6 years' experience in oncology within the pharmaceutical industry, including experience in the therapeutic area and 5 years in an in-house Medical Affairs role.
- GU therapeutic area expertise preferred.
- Experience working with cross functional medical and commercial teams.
- Understanding Medical Affairs activities and compliance guidance
- 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 and strong leadership skills.
- ICMJE 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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Senior Medical Director - Nutley, United States - Eisai, Inc.
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 Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This role is responsible for working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan.
The Sr Medical Director provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He 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.
The Sr Medical Director plays an important role in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations.
Essential Functions
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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. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
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