Principal Scientist, Clinical Research

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Create designs for clinical studies aimed at supporting regulatory submissions (FDA 510(k), PMA, CE-IVDR) related to Immunohistochemistry (IHC) & In Situ Hybridization (ISH), Companion Diagnostics (CDx), and Medical Devices, ensuring adherence to Good Clinical Practice (GCP), ISO standards, and relevant regulatory mandates.

• Act as a clinical and scientific intermediary with regulatory bodies, key opinion leaders, and external clinical sites, offering expert advice through the development of study protocols, clinical claims, and strategies for evidence generation.

• Write and evaluate essential regulatory documentation, including clinical study reports, technical files, and scientific publications to facilitate product clearance, approval, and commercialization.

• Build and sustain robust collaborative relationships with internal cross-functional teams (e.g., R&D, Regulatory Affairs, Medical Affairs, Quality Assurance, Data Management, Clinical Operations, Commercial) and external collaborators (e.g., CROs, investigators, key opinion leaders) to ensure effective execution of clinical programs.

• Provide support and mentorship to junior clinical scientists and lend technical expertise to cross-functional teams, while remaining current on pertinent regulatory expectations, clinical guidelines, and advancements in diagnostic technologies within the IVD sector.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Healthcare, or a related field with over 8 years of experience in clinical research, particularly with substantial experience in US and/or EU trials.

• Comprehensive knowledge of clinical study design and methodologies within the diagnostics, medical device, or pharmaceutical industries, specifically for products targeting the US and EU markets.

• Proven capability to identify and address complex challenges in the execution of clinical trials and scientific interpretation.

• Proficient in critically reviewing and interpreting scientific and clinical trial data, overseeing the scientific components of study protocols and reports.

• Exceptional communication (both written and verbal) and interpersonal skills for effective collaboration with cross-functional stakeholders.

🏝️ Benefits

• Opportunities for professional development.