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.
This position will provide leadership, project and study management oversight to plan, conduct and/or manage all operational aspects of clinical development projects in multiple Phases supporting the indications within the Neurology Business Group.
As a key stakeholder, must contribute to the overall strategic direction and vision of the clinical operations function.
Responsible for building and maintaining relationships; internally and externally, thereby requiring exceptional vendor management, open, effective and proactive communication and negotiation skills. Demonstrate excellent understanding of the drug development process in order to effectively manage internal and external cross-functional teams. Demonstrate operational excellence to coordinate, manage and execute all clinical study related activities and must be adept at assessing complexity of work and provide 'hands on' direction and support. Responsible for the development and management of study budgets within defined financial goals. Must have the ability to mentor clinical operations staff with their growth and development to maintain high quality staff and overall performance. Contribute to the individual and team development through training initiatives and team building activities. Ensures all clinical trials are executed in compliance with ICH-GCP guidelines/regulations, SOPs/SWPs and participates in the planning of quality assurance activities with accountability for the inspection readiness of assigned programs.
Job Qualifications :
* Bachelor’s degree in biological science, nursing, pharmacy, or equivalent area of study is required
* Minimum 10+ years experience in the pharmaceutical industry in a position or positions performing clinical operations functions
* At least 5 years of clinical project management experience in managing large global clinical trials (Phases I-III) required
* Strong clinical study management skills
* Requires excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills
* Electronic data capture experience, particularly Inform, as a plus
* Global trial experience required
* Experience in Alzheimer’s Disease therapeutic area preferred, but not required
* Experience in CNS preferred, but not required
* Excellent working knowledge of ICH GCP guidelines, FDA and EMA regulations
* Excellent written and oral communication and presentation skills
* Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward
* Ability to manage multiple priorities, while maintaining attention to detail is critical
* Experience operating effectively within a matrixed environment
* Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
* Excellent computer skills (MS Office Suite, Project, Word, Excel, PowerPoint, and IXRS/EDC platforms)
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