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 Executive Medical Director, Global Medical Affairs for Alzheimer's Disease provides strategic and operational leadership to the medical affairs organization focusing on the highest scientific integrity and standards, driving innovation and providing patient focused healthcare. The Executive Medical Director, Global Medical Affairs leads strategy and tactical operations for medical affairs functions across all franchise projects to include effective operation of the Medical Strategy team. The Executive Medical Director is responsible for setting medical strategy for Global Alzheimer's Disease pipeline compounds and ensuring regional alignment with US strategy and supportive tactics for the portfolio of near-launch products and new indications. The position interacts closely with the CMO, all regional heads MA, and Global Clinical Development organizations, Global Value and Access, sales and marketing and other cross-functional stakeholders to ensure effective portfolio optimization and resource utilization. This role provides strategic medical and clinical expertise to internal and external stakeholders and is responsible for representing Eisai Inc. externally with key opinion leaders, healthcare providers and other external stakeholders. This role may be responsible for overseeing certain post-approval studies in collaboration with the commercial organization. The selected individual works within a global matrix organization, through partnering with other therapeutic groups and regional groups, as well as through collaborating with Global Pharmacovigilance to ensure compliance with internal and external regulatory requirements of each region.
- Leads and oversees development of innovative medical and clinical strategies, including guidance on study protocol, interpretation of clinical data and literature reviews. Ensures application of state-of-the art scientific and ethical methods and ensures timelines and budgets are met by proactively dealing with obstacles. Serves as medical leader and clinical expertise resource to the medical science liaison teams and other field teams overseeing interactions/advocacy development with key opinion leaders or other external customers.
- Represents Eisai, Inc. externally by providing key opinion leaders, healthcare professionals, regulatory agencies and professional groups with needed medical and scientific information and education about Eisai’s innovations.
- Collaborates closely with Global Value and Access and Clinical Development teams on all clinical development plans for Phase II and Full Development programs as they relate to the achievement of reimbursable Target Product Profiles.
- Partners with cross-functional stakeholders to ensure effective portfolio and resource optimization (incl strategic lifecycle management input across the Alzheimer's Disease portfolio) and close collaboration with GNBU Marketing on post-marketing activities. Generation of a constant flow of high quality data through clinical research for all key Global Development of innovative MA clinical strategies to complement the activities of the Clinical Development organization.
- Stays abreast of all external environmental compliance and regulatory issues in order to provide the highest level of input into issues of risk under the domains of responsibility. Partner with Regulatory Affairs on scientific interactions with regulatory bodies.
- Directs the selection and development of talent for the MA Global function and develops a culture of accountability and innovation across the Medical Affairs organization.
- M.D. degree strongly preferred. U.S. board certification desirable.
- Approx.10 years in clinical development (Phase IV) and medical development (promotional materials, advisory boards, POA meetings, with 5-7+ years of experience in commercial medical affairs
- Experience in Alzheimer's Disease or Neurodegenerative Disease
- Some experience in clinical research (Phase I-IV) preferred.
- Excellent scientific written and oral communication skills.
- Experience working with medical, marketing and sales teams.
- Strong knowledge of FDA regulations, ICH guidelines for the conduct of clinical studies.
- Strong knowledge of biological science, particularly human pharmacology.
- Experience guiding teams in successfully advancing clinical trials from execution to completion and communication of final study reports.
- Proven experience in managing external (CRO) service providers to meet/exceed objectives and budgets.
- Action oriented individual with excellent execution of strategies
- Ability to collaborate effectively with and share accountability with cross-functional stakeholders across a global matrix organization.
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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