Clinical Development Director

hace 4 semanas


Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completo
Job Description:

As a key member of our clinical development team, the Associate Clinical Science Development Director will provide clinical development expertise to advise clients in early through late-stage development of medical products. This role will contribute to the design and conduct of clinical trials, including protocol development and implementation, statistical analysis plans, and data interpretation. The successful candidate will also act as a clinical science liaison, establishing relationships with key opinion leaders and principal investigators to provide enhanced peer-to-peer clinical/medical support. Additionally, this role will support the clinical trial proposal process, providing research and analysis to summarize the epidemiology, standard-of-care, and competitive environment for given opportunities.

Responsibilities:
• Develop, design, and optimize clinical trial protocol synopses and full Phase I-IV clinical trial protocols.
• Clinical science liaison activities, including supporting key opinion leaders, principal investigators, and clinical trial sites.
• 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.

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