Job Summary (Primary function)
The Assoc Dir, Clinical Research Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or therapeutic area.
Essential Functions of the Job (Key responsibilities)
- Development of protocols for clinical studies.
- Preparation of clinical development plans.
- Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other FDA submissions.
- Monitor, review and summarize safety and efficacy data in ongoing studies.
- Assist with study design for exploratory development.
- Will lead the clinical matrix teams for assigned compounds.
- Represent exploratory development on project teams.
- Develop relationships with appropriate consultants.
- Write abstracts and present data at scientific meetings, both internally and externally.
- Serve as liaison to project teams, CRO's and others.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
- Minimum of 2 - 4 years of experience in research with at least 1 or more years of drug development experience are required.
- Prior Oncology Drug Development experience a plus.
- Ability to multi-task and work in a fast-paced environment.
- Excellent written and oral communication skills.
- Strong Analytical ability.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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