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Medical Director Global Medical Affairs

Woodcliff Lake, NJ, United States

Posted on
Nov 30, 2021

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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 The Global Affairs Medical Director will provide medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area. Under the direction of the Executive Medical Director, this role will be responsible for working with key stakeholders to develop and execute the medical affairs plan, including new indication launches, post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan. Provide 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 will utilize expert medical/scientific knowledge in assigned therapeutic area to provide strategic input for the development of product strategies and liaise with external stakeholders to solicit feedback and strengthen Eisai's medical reputation in the disease state community. This role is responsible for approval of medical and scientific content of all relevant materials/communications.Essential Functions Medical Affairs Strategic Plans: Under the direction of theExecutive Medical Director, 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. Medical Launch preparation and execution will be a major part of this position. Phase IV 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. Serve as study director for trials. Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas. 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. 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.Requirements Board Certified in therapeutic area and US fellowship training, or MD with 4-5 years' experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 6 years' experience within the pharmaceutical industry, including experience in the therapeutic area and 5 years in an in-house Medical Affairs role. Clinical research experience, including conducting/participating 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. Oncology therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise products. Experience in medical affairs launch of oncology molecules 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. ICMJE guidance/general publication practices Current ACCME guidelines Sound computer skills including Microsoft Word, and PowerPoint Familiarity with statistical methodology PhRMA Code Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under state law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine due to a medical condition (including p regnancy-related), or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. 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. **MEMBERS ONLY**SIGN UP NOW***. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: E-Verify Participation Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, p regnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law. Eisai is an Equal Opportunity Employer - Minority / Female / Disability / Vet

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