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Description
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

Qualifications

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


Associated topics: aoa, breast, cancer, hem onc, hematology, lah, oncology, physician md, physician md do, thedacare

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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