Description
Eisai Inc., Eisai Medical Research and Eisai Corporation of North America are U.S. subsidiaries of Tokyo-based Eisai Co., Ltd., a research-based human health care company, that discovers, develops, and markets products throughout the world.
At Eisai (a-zi), caring for people is our work. Satisfying unmet medical needs and increasing benefits to patients, their families, and caregivers is Eisai's human health care (hhc) mission. This includes the development of innovative medicines-notably the discovery of the world's most widely used treatment for Alzheimer's disease.
As a company growing at a fast pace, Eisai offers its employees opportunities to thrive. We recognize that our people are our greatest asset, and are committed to providing a work environment that will attract and retain talent. Eisai enables and empowers all employees to make significant contributions. That is our quest. That is our promise. That is what makes us Eisai.
With more than 2,500 employees in the U.S. and sites located in Woodcliff Lake, NJ, Ridgefield Park, NJ, Baltimore, MD, and Research Triangle Park, NC, we work and live by our values: Integrity, Respect, Professionalism, Quality and Teamwork.
Senior Director, Drug Safety Andover- Biopharmaceutical Assessments Core Function Unit
General Summary:
Eisai's corporate philosophy focuses on meeting the diverse needs of patients and their families and increasing the benefits that health care provides. We express this philosophy with the phrase human health care, and continue to concentrate efforts on its realization worldwide. Throughout the company's 68 years of operation, drug discovery has been an integral part of its mission to advance human health care for patients and their families, as well as a major contributor to Eisai's success. Today, Eisai is Japan's third largest pharmaceutical company, ranking in the top 25 worldwide. Eisai's global R & D efforts are focused in several therapeutic areas, including central nervous system, oncology, cardiovascular, gastrointestinal, and inflammatory diseases. Eisai in Andover, MA, is the center for product creation in the U.S., with an emphasis on finding new treatments for inflammatory diseases and cancer.
Primary responsibilities, specific duties:
We are now seeking to fill the new post of Senior Director, Toxicology, who will report to the Executive Directof of Global Drug Safety, Biophamaceutical Assessments Core Function Unit (BA-CFU) in Eisai Product Creation Systems (EPCS). The qualified candidate will provide strategic planning, implementation and oversight to ensure proactive nonclinical toxicology support for drug discovery and development programs in Eisai Inc Andover, and to participate in preclinical safety assessments for global Product Creation Projects in all over the EPCS.
Responsible for initiating, coordinating and implementing strategic decisions/risk assessments on toxicology studies and the safety pharmacology to support drug discovery and development projects in EPCS
Provide technical oversight on the conduct of safety pharmacology and toxicology studies ensuring quality and relevance of the information needed to support goals for BA-CFU in EPCS
Manage the preparation and presentation of nonclinical toxicology data for EPCS project teams, regulatory agencies and other internal and external arenas.
Develop priorities, resource requirements and timelines for nonclinical safety pharmacology and toxicology studies.
Conduct and coordinate scientific review of internally and externally generated nonclinical safety pharmacology and toxicology data
Develop, train and lead the Toxicology group in Drug Safety Andover..
Participate and provide expert input on drug discovery and development project teams, Global Leadership Team in BA-CFU, regulatory agencies and other internal and external governance bodies
Prepare regulatory documents including nonclinical sections of INDs, NDAs, Investigator Brouchures and annual IND and NDA reports
Manage and track budgets for vended studies, evaluate cost proposals, select Contract Research Organizations, track timelines and deliverables to meet goals
Review, analyze and summarize nonclinical toxicology-related study reports from global Eisai marketing partners
Participate in the review and analysis of in-license drug candidates
Manage and maintain GLP in Drug Safety Andover
Manage resource allocations and timelines in Drug Safety Andover.
EDUCATION AND EXPERIENCE:
Ph.D. and post-doctral experiences
Diplomate, American Board of Toxicology
15+ years of relevant experience in the field of toxicology in drug development of Pharmacological and the relevant industries
Proven multiple records of both IND and NDA submissions to FDA and other countries
Proven record of successful ability to work in interdisciplinary team settings and positive interactions with regulatory agencies
Strong leadership; interpersonal, verbal and written communication skills
Eisai offers an outstanding compensation and benefits package, including 401(k) match. For more information and other job postings, please visit the Eisai web site at www.eisai.com.
Eisai conducts background checks and pre-employment physicals. We are an equal opportunity employer. M/F/D/V
At Eisai, we recognize that our employees are our greatest asset. That is why we reward them with highly competitive salaries, annual incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, Tuition and Health Club Reimbursement, and the list doesn't stop there. Since we intend to recruit the best of the best candidates, this is how we maximize our competitive advantage in the marketplace.
EOERequirements
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