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Senior Director, Global Medical Affairs, Real World Evidence & Medical Value at Eisai in Woodcliff Lake, New Jersey

Posted in Other 30+ days ago.

Type: Full Time

Job Description:

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.


Accountable for the leadership and management of Epidemiology and Real-World Evidence (RWE) within NBG Global Medical Affairs, the incumbent serves as the key contact and strategic partner to the Medical Affairs, Clinical Development, and Commercial teams to ensure excellence in the development, coordination, and execution of the Epidemiology & RWE research programs at the global level.

You will be responsible for developing and maintaining excellence in Epidemiology/RWE capabilities, optimizing individual and team performance, ensuring appropriate deployment to projects and other functional activities that are necessary to generate the medical evidence required by regulator, payers, and physicians to facilitate patient access and appropriate use of Eisai medicines.

These responsibilities require an extensive experience in the pharmaceutical industry with broad and deep knowledge of clinical epidemiology, RWE generation activities, value demonstration, value communication, and how these activities relate to product development and commercialization processes at all life-cycle stages, as well as the ability to influence internal partners and external stakeholders. The successful candidate will be able to demonstrate strong leadership capabilities.

To accomplish our goals and enable the best patient outcomes, we seek out the following core capabilities:

* A track record of building and maintaining a deep connection to medical practice and healthcare service delivery

* Collaborative/matrix management skills with a focus on leading diverse groups (e.g., cultural, geographical, functional) to achieve excellent results in shared goals

* Strong, effective communication skills with the ability to distill complexity down to what matters to different stakeholders

* Strong financial/budget management and project management skills

* Strong business acumen

* A willingness and capability to execute data analysis (statistical analysis) as it relates to phase IV and RWE studies


* Translate the strategic plan and vision of NBG 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.

* Under the direction of the CMO, the incumbent will work with key stakeholders, management, and functional area leads to develop strategic and aligned Medical Affairs Plans with the U.S. and other regions for the therapeutic areas and will be expected to communicate and represent these plans to upper management/senior leadership. This includes responsibility for continuously updating plans and communicating changes.

* 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.

* Help transform Global Medical Affairs into Global Medical Value teams with three strategic roles: communicating scientific evidence, providing market-based strategic input to drug development and portfolio management, and overseeing the effort to produce Big Data and real-world evidence.

* Lead the recruitment, retention, and development of the team to build capabilities and innovation that positions Eisai as a leader in Epidemiology and RWE generation.

* Identify strategic opportunities and key issues, generate and analyze real-world evidence (RWE) and excel at communicating scientific evidence and collaborating with key stakeholders (i.e., healthcare providers, payers, and policy-makers), particularly in helping physicians navigate in a far more complex healthcare universe.

* Generate and present high-quality scientific knowledge to the market and educate key stakeholders about next-generation products, and help Eisai Global Medical Affairs teams to become a strategic ace in an era of Big Data.

* Link scientific and clinical results to patient needs and patient outcomes, adding value at every stage of a drug s development and designing more effective clinical programs and launches.

* 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 from continual market feedback and a better, more nuanced understanding of the market and patient needs. Increased engagement with stakeholders helps Eisai focus on patient outcomes.

* Provide market-based strategic input to drug development and portfolio management by leveraging deep relationships with prescribers and opinion leaders and continually collecting feedback and signals from early identification of promising compounds through post-launch market strategies.

* Design and implement data generation strategies and to integrate classical phase IV studies with RWE and Big Data analytics. This is done by working as an integral part of cross-functional product development and product management teams and increasing the company s understanding of unmet medical needs, attractiveness of treatment pathways and value of clinical trial protocol options, as well as speed of regulatory approvals, reimbursement pathways and launch success rates.


* Advanced degree in Epidemiology, or Public Health, or a related discipline such as Health Services or Health Outcomes Research. MD/ Neuropsychology PhD degree is a strong asset

* 12 + years of relevant experience, including a minimum of 5-7 years in the pharmaceutical/biotechnology industry

* A track record of peer-reviewed scientific publications demonstrating expertise in Epidemiology and RWE

* Understanding of Epilepsy, Dementia and sleep disorder

* Extensive experience working with primary and secondary data, as well as Big Data in both US and global. Preferred experience with pragmatic trials.

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