Sarah M.
Executive Director of Clinical Science and Medical Writing at Celcuity
- Role
- Executive Director, Clinical Science and Medical Writing at Celcuity
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Sarah M.
Ph.D. level cell biologist with over 25 years of biotechnology experience in research and development, including clinical and regulatory writing, clinical and translational science, project management, clinical operations, vendor management, and preclinical basic research. Broad scientific research expertise in inflammation, cell biology, molecular biology, biochemistry, and oncology. Supervisory experience of Ph.D. level scientists. Key competencies include:• Clinical and regulatory writing including Clinical Study Protocols, Investigator\'s Brochures, Clinical Study Reports, IND and NDA clinical modules, PIP, PSP, FDA meeting requests, FDA briefing books, EMA request for scientific information, responses to health authority queries/RFIs, SOPs, Style Guides, and clinical and nonclinical study plans.• Clinical and Translational Scientific lead for Phase 1-3 studies• Effective team leader and project manager• Vendor Management• Excellent communication and writing skills • Critical thinker
Experience
Executive Director, Clinical Science and Medical Writing
Jun 2017 — Present
Education
Indiana University Bloomington
B.S., Microbiology
University of California, San Francisco
Ph.D, Biochemistry
Skills
- Cell
- Assay Development
- Cell Culture
- Pcr
- Biochemistry
- Drug Discovery
- Western Blotting
- In Vitro
- Molecular Biology
- Protein Expression
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