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Associate Director, Clinical Research - Oncology

Employer
Eisai Inc
Location
Woodcliff Lake, New Jersey
Salary
Competitive Salary, Bonus, LTI, and Benefits Package
Closing date
Jun 30, 2019

Job Details

 

The Associate Director, Clinical Research will assist the Clinical Lead and/or Study Director in the planning and implementation, execution, day to day managing and reporting of clinical trials for Lenvima. Additional responsibilities include: assisting with the preparation of the clinical trial synopses, protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report, etc.; training new CRO monitors and CRAs on protocol and processes; assisting with the preparation of the NDA documents; preparing clinical sections of IND annual safety report and annual Investigator brochure updates; assist with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.); and assisting with the preparation of the publications (abstracts, articles, etc.) pertinent to the study.

Responsibilities include but are not limited to:

1. Assisting the Clinical Lead and/or Study Director in the planning and implementation, execution, day to day managing and reporting of clinical trials.

2. Assisting with the preparation of the clinical trial synopses, Protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report, etc.

3.Training new CRO monitors and CRAs on protocol and processes

4. Assisting with the preparation of the NDA documents

5 Preparing clinical sections of IND annual safety report and annual Investigator Brochure updates

6. Assisting with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.)

7. Assisting with the preparation of the publications (abstracts, articles, etc.) pertinent to the study

Job Qualifications
• New Entrants to Pharma: MD Board Certified or Board Eligible in Hematology and/or Oncology with an understanding of the fundamentals of clinical development; In lieu of clinical trial research experience will consider substantial academic Oncology research experience
• Ph.D. or PharmD with 5 years of clinical research in the pharmaceutical industry
• A thorough understanding of clinical research methodology including study design, protocol writing and CRF preparation is required as is a knowledge of GCP and local regulatory requirements.
• Working knowledge of the IND/NDA process acquired through direct industrial experience is required.
• Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area.

Company

Welcome to Eisai Inc.

Eisai Inc. (pronounced ā-zī) is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd, a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business.

Headquartered in Woodcliff Lake, New Jersey, we are dedicated to a tradition of genuine concern for people and are driven by the desire to help meet the diverse health care needs of patients and their families and caregivers. We are an agile, entrepreneurial organization managed by experienced leadership, backed by the strength, stability and historical successes of Eisai Co., Ltd., which has a strong and lasting commitment to the U.S. market.

Our heritage and mission have earned us recognition as an innovative, efficient, solution-oriented pharmaceutical company - a company that effectively works with healthcare professionals, hospitals and managed care organizations to develop and market specialty products that help address unmet needs. Our ability to forge strong alliances gives us a competitive edge.

In the United States, our rapid growth and strong performance result from putting patients and their families first when making decisions and from empowering the people who manage our operations. Eisai employees personify our values of integrity, respect, professionalism, quality and teamwork.

As you continue exploring our corporate web site, you will learn more about how our commitment to hhc is a motivating force for everything we do and everything we produce.

Follow @eisaius


 

Company info
Website

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