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Clinical Science Development Director
hace 2 meses
We are seeking an experienced Clinical Science Development Director to join our team at Thermo Fisher Scientific. As a key member of our EMEA team, you will be responsible for developing and executing clinical trial strategies to support the growth of our business.
Key Responsibilities- Develop and Optimize Clinical Trial Protocols: Design, develop, and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols to ensure scientific rigor and consistency.
- Clinical Science Liaison Activities: Support key opinion leaders, principal investigators, and clinical trial sites to ensure successful trial execution.
- Scientific Deliverables: Contribute to clinical trial scientific deliverables by providing scientific review and input to key study documents.
- Clinical Development Plans: Build clinical development plans and strategic program assessments to support business growth.
- Regulatory Submissions: Support global regulatory submissions, including Pre-IND, IND, NDA/BLA, and other US regulatory submissions.
- Education: MD, PhD, PharmD, or equivalent in a scientific discipline or related field.
- Experience: 6+ years of experience in a clinical research setting, including biotech/pharmaceutical industry, academia, government, and/or non-profit.
- Skills: Excellent interpersonal and communication skills, strong attention to detail, good organizational, prioritization, and time management skills.
- Knowledge: Familiarity with GCP/IHC, FDA, and other regulatory guidelines, global requirements for regulatory approval and marketing of medical products.
