Oversees the direction, planning, execution, clinical trials/research and the data collection activities. Contributes to implementation of clinical protocols, and facilitates completion of final reports. Recruits clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases III/IV for company products under development. Participates in adverse event reporting and safety responsibilities monitoring. Coordinates and provides reporting information for reports submitted to the regulatory agencies. Monitors adherence to protocols and determines study completion. Coordinates and oversees investigator initiations and group studies. May participate in adverse event reporting and safety responsibilities monitoring. May act as consultant/liaison with other corporations when working under licensing agreements.
The Medical Director of Global Medical Affairs in Neurology will have accountability to the epilepsy portfolio and provide leadership/support as a key partner to Clinical Development, Real World Evidence and Commercial. The incumbent will provide therapeutic area expertise in epilepsy, advance data generation, publication and medical education initiatives, as well as ensure global-regional, and cross-disciplinary alignment and collaboration.
The Medical Director is a key member of the Neurology Business Unit responsible for developing and maintaining excellence in medical affairs activities, building best-in-class capabilities and leading activities that are necessary to generate and publish evidence that fills knowledge gaps and facilitates the appropriate and optimal use of Eisai medicines to improve patient outcomes.
The incumbent will build enduring collaborations/partnerships with scientists, clinicians and other key stakeholders as appropriate, with the goal to contribute to the epilepsy literature and initiatives that optimize patient outcomes. The position includes participation in governance and review committees.
These responsibilities require broad MD neurology experience with expertise in epilepsy and a record of scientific interest, publications and clinical experience. Experience in the pharmaceutical industry is preferred with a solid background in medical affairs activities – data generation, scientific publications/communications, product development and differentiation and contributing medical expertise across the lifecycle.
The successful candidate will have advanced written and verbal communication skills and a flexible leadership style that engages and inspires cross-disciplinary colleagues with varying viewpoints to meet and exceed our shared objectives. The Director will liaise with other functions on shared initiatives. A sophisticated understanding of the evolving healthcare and neurology landscape including the integration of innovative approaches to advance practice, improve dissemination and implementation of evidence-based treatments in epilepsy is of great interest.
Translate the strategic plan and vision of the Global Medical Affairs and overall therapeutic area to develop research and study designs for the generation and delivery of high quality, scientifically robust evidence along the product lifecycle on time and on budget.
The incumbent will work with key stakeholders, management, and functional area leads to develop strategic and aligned US Medical Affairs Plans for the therapeutic area and will be expected to communicate and represent these plans to upper management/senior leadership. This includes responsibility for continuously updating plans and informing
Provide leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. Maintain external orientation by participating actively in external events and activities. Strengthen Eisai’s medical reputation through successful management of medical dimensions of products
Lead the recruitment, retention, and development of the team to build capabilities and innovation that positions Eisai as a leader in Neurology
Generate and present high-quality scientific knowledge and educate key stakeholders within and outside of the organization
Prioritize address patient unmet needs through scientific activities that focus on patient needs and patient outcomes
Engage stakeholders and effectively, transparently communicate pertinent science by sorting through a deluge of data and identify the best use for new technologies (e.g., drugs, diagnostics, etc.) that has become an overwhelming task for key stakeholders—physicians, payers and healthcare providers are struggling with data overload more transparent data on drug performance.
Build long-term relationships with a variety of stakeholders to benefit patients with neurological conditions and advance understanding on the appropriate use of our products.
Design and implement data generation strategies working as an integral part of cross-functional product development and product management teams and increasing the company’s understanding of unmet medical needs, precision medicine, treatment pathways, etc.
MD in neurology with advanced clinical specialization in epilepsy and interest in maintaining a deep understanding/connection to medical practice and service delivery
Track record of academic achievements and publications
Minimum 1-4 years’ experience in the pharmaceutical industry; Launch experience desired
Record of success partnering with internal and external stakeholders to achieve common goals
Well-established experience in complex problem solving, leadership through influence, and building support for new approaches with diverse stakeholders in a complex, fast-paced environment
Proven ability to be strategic and forward-thinking to enable execution of critical objectives
Strong financial/budget management and project management skills.
Strong business acumen