Principal Clinical Research Scientist - Clinical Research Jobs

Location: United States-North America – US Home-Based

Job responsibilities

Development of protocols for clinical studies.
Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Clinical Study Reports, Annual Reports and other Health Authority submissions.
Monitor, review and summarize safety and efficacy data in ongoing studies.
Represent clinical development on project teams.
Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
Serve as liaison to project teams, CRO’s, Clinical sub-teams, and others.
Maintain updated knowledge of competitive landscape in regard to assets with similar MOA and/or evolving standards of care for indications of interest.

Qualifications

What we’re looking for

Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
Minimum of 8 years of experience in drug development with at least 5 years as clinical research scientist in oncology are required. Hematology experience preferred but not required.
Strong ability to manage time and work independently.
Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel, PowerPoint, and Acrobat software; ability to embrace new technologies.
Excellent communication, presentation, interpersonal skills, both written and spoken (English required), with an ability to inform, influence, convince, and persuade.
Flexibility and the ability to mentor and/or manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.

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