Senior Medical Director, Early Clinical Development
Vor 7 Tagen
Overview
Summary
The Sr. Director 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.
Duties and Responsibilities
- Act within compliance and legal requirements as well as within company guidelines.
- Contribute positively to a strong culture of business integrity and ethics.
- Serve as liaison to project teams, CRO's and others.
- Write abstracts and present data at scientific meetings, both internally and externally.
- Develop relationships with appropriate consultants.
- Represent development on project teams.
- Will lead the clinical matrix teams for assigned compounds.
- Review and summarize safety data in ongoing studies for clinicians.
- Monitor, review and summarize safety and efficacy data in ongoing studies.
- Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, CSRs and other FDA submissions.
- Preparation of clinical development plans.
- Development of protocols for clinical studies.
Requirements
- Strong Analytical ability.
- Excellent written and oral communication skills.
- Ability to multi-task and work in a fast-paced environment.
- Prior Oncology Drug Development experience a plus.
- Minimum of relevant experience in research with a focus on drug development is preferred, but not required. We value diverse experiences and encourage candidates with different backgrounds to apply.
- Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
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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