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Executive/ Senior Director, Clinical Research Scientist
View: 164
Update day: 25-04-2024
Category: R & D IT - Software
Industry: Biotechnology Research
Position: Mid-Senior level
Job type: Full-time
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Job content
Job SummaryThis position is responsible for working with the physicians and other clinical scientists within Clinical Development to provide clinical research support for programs as assigned by phase or therapeutic area.
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, Annual Reports and other Health Authority submissions.
- Monitor, review and summarize safety and efficacy data in ongoing studies.
- Represent clinical development on project teams.
- Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
- Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
- Serve as liaison to project teams, CRO’s, specific vendors in collaboration with Clin Operations, Clinical sub-teams, and others.
- Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.
- Ability to accommodate up to 20% travel or as business dictates
- Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
- Minimum of 8 years of experience in research with at least 5 years of drug development experience are required. Alternative drug development experience will be considered.
- Prior Oncology Drug Development experience is strongly preferred for the Senior Director level.
- Ability to work independently, multi-task, and work in a fast-paced environment.
- Excellent written and oral communication skills.
- Strong Analytical ability.
- Ability to travel 20-30% when required.
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Deadline: 09-06-2024
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