The Sr. Medical Director, Global Medical Affairs - Epilepsy will be responsible for working with key stakeholders to develop and execute the medical affairs plans for pipeline assets and marketed Epilepsy Products (Fycompa & Banzel), including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plans.
The Sr. Medical Director provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs Department for specific products in the Neuroscience therapeutic area. Utilizing expert medical/scientific knowledge in assigned areas of focus, the Sr. Medical Director provides strategic input for the development of product strategies. The Sr. Medical Director liaises with external stakeholders and key opinion leaders to solicit feedback and strengthen Eisai’s medical reputation in the disease state community. The Sr. Medical Director reviews and approves medical and scientific content for all relevant materials/communications. The Sr. Medical Director interacts with the Medical Science Liaisons for products in late stage development.
Responsibilities include but are not limited to:
1. Development of Medical Affairs Strategic Plans: The Sr. Medical Director works with key stakeholders, management, and functional area leads to develop strategic and aligned Medical Affairs Plans for Epilepsy. The incumbent will communicate and represent these plans to senior leadership and continuously update plans and inform stakeholders of progress.
2. Directing and Designing Phase IV Clinical Studies: The Sr. Medical Director directs and designs strategies to include planning and implementation of Phase IV clinical development programs for assigned products and provides medical oversight for protocol development, interpretation of trial results, and final study report conclusions and publications. The Sr. Medical Director serves as study director for trials. The incumbent provides critical medical input into the lifecycle management strategies.
3. Serving as the Medical/Scientific Subject Matter Expert: The Sr. Medical Director serves 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. The incumbent approves medical and scientific content for Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned areas.
4. Providing External Leadership: The Sr. Medical Director provides leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. The incumbent maintains external orientation by participating actively in external events and activities to strengthen Eisai’s medical reputation through successful management of medical dimensions of products.
5. Providing Internal Leadership: The Sr. Medical Director serves as Medical Affairs Liaison on pipeline products providing input on clinical development plan, clinical trials, medical affairs launch preparation, publication planning, training, health outcomes strategic planning
* Board Certified in Neurology and/or Psychiatry, ideally with expertise in Epilepsy or as an Epileptologist with Medicine US fellowship training OR MD with 5+ years of US Medical Affairs experience /5-7 years of experience within the pharmaceutical Epilepsy or Neurodegenerative Diseases
* Global experience a plus
* Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area. Experience reviewing promotional materials from a medical perspective, publication planning, relevant medical society membership and track record of active participation/attendance, and strong presentation skills.
* Experience working with cross functional medical, clinical development and commercial teams
* The ability to work independently
Must Know:
* Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise and pipeline products
* Understanding US 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
Travel: Approximately 50%
Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
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, pregnancy, 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 from tblHiringOrgDefaults |
