Clinical Science Development Director, EMEA

hace 5 días

Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completo
Job Summary

We are seeking a highly experienced Clinical Science Development Director to join our team at Thermo Fisher Scientific. As a key member of our clinical development team, you will be responsible for leading the development of clinical trial protocols, scientific deliverables, and strategic program assessments.

Key Responsibilities
  • Protocol Development: Develop, design, and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols.
  • Clinical Science Liaison: Support key opinion leaders, principal investigators, and clinical trial sites through clinical science liaison activities.
  • Scientific Deliverables: Contribute to clinical trial scientific deliverables by providing scientific review and input to key study documents, ensuring scientific rigor, consistency, and alignment with strategy.
  • Clinical Development Planning: Build clinical development plans and strategic program assessments.
  • Advisory Boards: Coordinate key opinion leader advisory boards.
  • Feasibility Assessments: Contribute to clinical trial feasibility assessments.
  • Competitive Intelligence: Provide competitive intelligence support for the request for proposal process.
  • Regulatory Submissions: Support for Pre-IND, IND, NDA/BLA, and other US regulatory submissions, as well as global regulatory submissions.
Requirements
  • Education: MD, PhD, PharmD, or equivalent in a scientific discipline or related field required.
  • Experience: 6+ years of experience in a clinical research setting, such as biotech/pharmaceutical industry, academia, government, and/or non-profit.
  • Expertise: Expertise and experience with the conduct of global clinical trials, clinical training, and/or experience strongly preferred.
  • Therapeutic Areas: Deep experience in Neuroscience/Ophthalmology or Immunology/Rheumatology/Inflammation, with the ability to cross-cover in additional therapeutic areas strongly preferred.
  • Regulatory Knowledge: Familiarity with GCP/IHC, FDA, and other regulatory guidelines, as well as global requirements for regulatory approval and marketing of medical products.
  • Soft Skills: Excellent interpersonal and communication skills, strong attention to detail, good organizational, prioritization, and time management skills, ability to work on multiple projects simultaneously, and highly proficient in standard computer software (MS Word, Excel, PowerPoint).

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