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.
* MD required; Sub-specialty training in Neurology or Psychiatry * A minimum of 5 years in pharmaceutical clinical development with experience directing Neurology Phase II-III global multicenter studies * Strong interpersonal and leadership skills; demonstrated ability to build consensus and drive change in a matrix environment with cross functional teams * A thorough understanding of clinical research methodology including study design, protocol writing, and study report preparation * Comprehensive understanding of GCP of local regulatory requirements * Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience * Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action * Knowledge of medical, scientific and clinical research techniques in the neurology area * Previous participation in the selection of new compounds for clinical development and IND filing in neuroscience through technical evaluation of licensing and/or partnering opportunities. * Solid understanding of the drug development process based on experience gained in the pharmaceutical or biotech industry * Excellent oral and written communication and presentation skills * Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects preferred * Experience with pediatric and epilepsy studies is a plus * Annual travel required may be up to 10% (domestic and some international)
The Director, Clinical Research will design and oversee the conduct of clinical programs/studies for Phase II and III development of compounds targeting neurological disorders encompassing epilepsy and other studies. The Director will provide input into clinical development strategies as well as perform medical monitoring based on credentials, for these indications and potentially, others.
Responsibilities include but are not limited to:
1. Directing and implementing Clinical research plans and programs according to established design principles. Directing the integration of the CDP and DDP
2. Leading the development of Clinical Protocols to meet CDP objectives
3. Serving as a Study Director and driving the execution of studies from protocol concept to final report including interpretation of clinical data
4. Willing to serve as a Medical Monitor and possibly, Study Director for a study or clinical program; including review and monitoring study safety data Implementing strategies to identify, monitor and resolve clinical program/ trial issues. Leading the Clinical Subteam.
5. Serving as a SME to provide direction to all project team functions, Organizing Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOLs regarding program strategy and scientific advice
6. Interpreting study data and developing integrated summaries of safety and efficacy
7. Contributing clinical expertise to regulatory documents (e.g., briefing books, INDs, NDAs, etc.). May represent Clinical in discussions with Health Authorities
8. Acting as a coach and mentor to staff members across the NBG unit
9. Setting key deadlines and project milestones for projects within the function
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