Clinical Science Development Director, EMEA

hace 3 semanas

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

We are seeking an experienced Clinical Science Development Director to join our team in EMEA. The successful candidate will be responsible for developing and optimizing clinical trial protocols, providing scientific review and input to key study documents, and building clinical development plans and strategic program assessments.

Key Responsibilities
  • Develop, design, and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols
  • Contribute to clinical trial scientific deliverables by providing scientific review and input to key study documents ensuring scientific rigor, consistency, and alignment with strategy
  • Build clinical development plans and strategic program assessments
  • Coordinate key opinion leader advisory boards
  • Contribute to clinical trial feasibility assessments
  • Provide competitive intelligence support for the request for proposal process
  • Provide clinical strategy into health authority briefing packages
  • 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 required
  • Expertise and experience with the conduct of global clinical trials for medical products clinical training and/or experience strongly preferred
  • Seeking an experienced professional with exceptional client-facing skills
  • Familiarity with various clinical trial designs, including more complex trials (basket trials, umbrella trials, adaptive designs, master protocols, decentralized trials, pragmatic trials)
  • 6 + years of experience (following receipt of doctoral degree) 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 is strongly preferred
  • Familiarity with the operational conduct of global clinical trials
  • Knowledge of GCP/IHC, FDA and other regulatory guidelines
  • Knowledge of global requirements for regulatory approval and marketing of medical products
  • 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)

Why Thermo Fisher Scientific?

We are a leading provider of scientific instrumentation and software, and we are committed to advancing human health through innovation and collaboration. Our team is passionate about delivering exceptional results and making a meaningful impact in the lives of our customers and patients.

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