Associate Medical Director/Medical Director - Global IIS
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The Associate Medical Director/Medical Director, Global IIS provides medical leadership for medical affairs strategy, planning and supportive tactics for the assigned therapeutic area.
The Associate Medical Director/Medical Director, Medical Affairs will be responsible for working with key stakeholders and collaborators to lead the review of Investigator Initiated Studies (IIS), develop the IIS areas of interest. Qualified candidates must understand the medical affairs strategies and tactics and the medical affairs plan inclusive of medical education, research grants, scientific communication/publication components of the overall medical affairs plan.
As necessary, this position will also have broader medical affairs responsibility for assigned product(s) within the oncology therapeutic area. This encompasses working with key stakeholders to develop and execute the US or Global medical affairs plan, lead post-marketing research (investigator initiated and company sponsor studies), develop medical strategies and tactics, medical education, research grants, medical advisory boards, and scientific communication/publication components of the overall medical affairs plan. The individual who assumes this position will provide strategic development, planning, implementation and oversight of medical advisory boards and KOL management within the Medical Affairs department.
1. Clinical Research – Investigator Initiated [IIS] and Company Sponsored Research: Lead the review and oversight of investigator initiated concepts and protocols for Eisai commercial and pipeline molecules (with collaboration partner(s) as needed). Work with collaboration partner(s) to develop IIS areas of interests and the review of concepts and study protocols. For Eisai company sponsored or collaboration studies: Direct and design strategies, planning and implementation of Medical Affairs led research programs. Provide medical oversight for protocol development, interpretation of trial results, final study report, and publications. May serve as study director for trials. Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas.
2. Develop and Execute Medical Strategy: Work with key stakeholders, management, functional area leads, and collaborators to develop medical strategy (and plan) for assigned therapeutic area. Conduct gap analysis for assigned therapeutic area as a critical component for the development of medical strategy and plan. Working with cross-functional teams to develop detail and specific strategies. Under the direction of leadership, integrate medical strategies for assigned therapeutic area into US and Global medical plans. Communicate and represent medical strategies to all stakeholders including upper management/senior leadership within Eisai and collaborators. Continuously update medical plan and inform stakeholders of progress.
3. 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, Medical Affairs, and Commercial outputs for assigned therapeutic areas.
4. 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 MD in therapeutic area and US fellowship training, or MD with minimum 4+ years’ experience within the bio/pharmaceutical industry including 2 years an in-house oncology Medical Affairs role, or PhD or PharmD with 10 years’ experience in a clinical setting and/or bio/pharmaceutical industry, including 5 years in-house oncology Medical Affairs role.
• Clinical research experience, including conducting clinical trials Phase 1 thru Phase 4 studies. Experience reviewing clinical and pre-clinical research protocols.
• Experience reviewing promotional materials from a medical perspective, publications, publications planning activities, interaction with medical societies and advocacy organizations
• Strong presentation skills, with ability to develop effective presentations and moderate medically focused meetings
• Experience working with cross functional teams, including regulatory, legal, commercial, and development
• Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon assigned therapeutic area
• Understanding of the Medical Affairs functional area within the bio/pharmaceutical industry
• Understanding of Marketing concepts/strategies
•Knowledge of the pharmaceutical industry and marketplace
• FDA regulations/ICH guidelines regarding conduct of clinical studies (GCP etc)
•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 Office programs such as Word, PowerPoint, and Excel
• Familiarity with statistical methodology
• Understanding of the PhRMA Code
• Travel: 30%