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Clinical Development Director
hace 2 meses
Job Title: Clinical Development Director
Job Summary:
We are seeking a highly experienced Clinical Development Director to join our team at Thermo Fisher Scientific. As a key member of our clinical development team, you will be responsible for providing clinical development expertise to support the development of medical products.
Key Responsibilities:
- Provide clinical development expertise to support the development of medical products
- Contribute to the design and conduct of clinical trials, including protocol development and implementation, statistical analysis plans, and data interpretation
- Act as a clinical science liaison to establish relationships with key opinion leaders and principal investigators
- Support the development of clinical trial proposals and provide research and analysis to summarize epidemiology, standard-of-care, and competitive environment
- Collaborate with cross-functional teams, including clinical research, regulatory strategy, and biostatistics
- Develop and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols
- Contribute to clinical trial scientific deliverables, including scientific review and input to key study documents
- Build clinical development plans and strategic program assessments
- Coordinate key opinion leader advisory boards
- Contribute to clinical trial feasibility assessments and provide competitive intelligence support for the request for proposal process
- Support for Pre-IND, IND, NDA/BLA, and other US regulatory submissions
- Support for global regulatory submissions
Requirements:
- MD, PhD, PharmD, or equivalent in a scientific discipline or related field
- Expertise and experience with the conduct of global clinical trials for medical products
- 6+ years of experience in a clinical research setting, such as biotech/pharmaceutical industry, academia, government, and/or non-profit
- Deep experience in Neuroscience/Ophthalmology or Immunology/Rheumatology/Inflammation with the ability to cross-cover in additional therapeutic areas
- Familiarity with the operational conduct of global clinical trials, GCP/IHC, FDA, and other regulatory guidelines
- Excellent interpersonal and communication skills
- Strong attention to detail, good organizational, prioritization, and time management skills
- Ability to work on multiple projects simultaneously
- General familiarity with biostatistics and pharmacokinetics
- Expert in navigating scientific literature, interpretation of data, and display of data
- Ability to work both independently and in a team environment
- Highly proficient in standard computer software (MS Word, Excel, PowerPoint)
