Senior Medical Director, US Medical Affairs - Oncology

Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.

Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.

JOB REQUIREMENTS The Senior Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area.

The incumbent will be responsible for working with key stakeholders to develop, lead and execute the global medical affairs strategy and plan, including medical launch strategies and execution, post-marketing research, medical education, research grants, medical advisory boards, data gap analysis, real world evidence, and publication strategies and plans, and scientific communication components of overall medical operating plan, insight collection and distribution, and MSL plans. Provide strategic development, planning, implementation and oversight of Data Generation/Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area.

The Sr. Medical Director, US Oncology Planning will utilize expert medical/scientific knowledge in assigned therapeutic area to provide strategic input for the development of product strategies. Liaise with external stakeholders to solicit feedback and strengthen Eisai’s medical reputation in the disease state community.
Responsible for approval of medical and scientific content of all relevant materials/communications.
Mentor the personnel on his team in terms of their teamwork and management performance and coach his staff in career development and training.

Key Responsibilities:
1. Medical Affairs Strategic Plans: 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.

2. Data Generation/Medical Affairs clinical studies: Direct and design strategies, data gap analysis, planning and implementation of Medical Affairs (Phase II - 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.
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, clinical narratives, 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.

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.

Qualifications:

• Board Certified in therapeutic area and US fellowship training OR MD with 5-7 years experience within the pharmaceutical industry OR PhD or PharmD with 8+ years experience within the pharmaceutical industry, including experience in the therapeutic area.

• Clinical research experience, including conducting clinical trials in the Phase II-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.

• Ability to lead and manage a team of Medical Directors

Must Know:

• Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise products

• 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|

JOB DUTIES Job Qualifications
Qualifications:

• Board Certified in therapeutic area and US fellowship training OR MD with 5-7 years experience within the pharmaceutical industry OR PhD or PharmD with 8+ years experience within the pharmaceutical industry, including experience in the therapeutic area.

• Clinical research experience, including conducting clinical trials in the Phase II-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.

• Ability to lead and manage a team of Medical Directors

Must Know:

• Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise products

• 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|

JOB FOOTER 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|