Head of Clinical Research Science

• Lead Ciliatech’s European clinical and research activities
• Strengthen the scientific understanding of Ciliatech’s technology and products
• Develop and integrate scientific, preclinical and clinical evidence for clinical development, product performance, new indications and product development decisions
• Provide strategic and scientific oversight of Ciliatech-sponsored European clinical studies
• Work cross-functionally across Research & Development, Clinical, Medical, Quality and Regulatory functions
• Conduct and synthesise literature reviews, data mining and quantitative analyses
• Identify scientific and clinical knowledge gaps, unexplained outcomes and factors influencing product performance and clinical outcomes
• Formulate scientific hypotheses and propose evidence-generation plans
• Design and coordinate occasional preclinical research activities
• Translate scientific, preclinical and clinical findings into recommendations for leadership and functional teams
• Define or review study concepts, scientific rationale, objectives, endpoints and protocol assumptions
• Review study progress, emerging data, risks and scientific or operational issues
• Analyse and interpret clinical study results with scientific, medical, statistical and regulatory experts
• Maintain integrated scientific, preclinical and clinical evidence supporting products
• Investigate patient selection, surgical technique, device positioning, product performance and clinical outcomes
• Prepare or contribute to scientific abstracts, manuscripts, congress presentations, internal reports and peer-reviewed publications
• Maintain and update clinical sections of technical documentation supporting CE marking
• Prepare or contribute to Clinical Evaluation, PMCF and other applicable MDR clinical documentation
• Provide scientific and clinical input for responses to Notified Bodies and regulatory stakeholders
• Lead the European clinical and research function; define roles, priorities and resource needs
• Provide line management and strategic direction to the Senior Project Manager and assigned clinical personnel or contractors
• Coordinate interfaces across Research & Development, Clinical, Medical, Quality and Regulatory functions

• Advanced degree in life sciences, biomedical sciences, medicine, pharmacy, engineering or another relevant scientific discipline
• Significant senior experience in scientific research, clinical research and/or medical device development
• Strong experience in ophthalmology
• Experience developing scientific hypotheses and interpreting scientific, preclinical and clinical data
• Experience designing or overseeing clinical and/or preclinical studies
• Experience working cross-functionally with R&D, Clinical, Medical, Quality and Regulatory functions
• Experience leading clinical or scientific professionals and coordinating external partners
• Strong scientific reasoning, literature-review and hypothesis-driven research skills
• Ability to analyse and interpret scientific, preclinical and clinical data, including basic biostatistical outputs
• Strong understanding of clinical research methodology and study design
• Strong scientific and technical writing and presentation skills
• Knowledge of Good Clinical Practice, ISO 14155 and applicable European clinical research requirements
• Knowledge of EU MDR, Clinical Evaluation and PMCF
• Strategic leadership, prioritisation, delegation and people-management skills
• Ability to lead through influence across employees, contractors and external experts
• Professional fluency in English
• Ability to travel independently as required for clinical studies, scientific collaborations and meetings with external partners
• Regular European travel readiness
• Preferred: PhD, PharmD, MD or equivalent advanced scientific degree, preferably in ophthalmology, glaucoma, medical devices or biomedical research
• Preferred: Experience in glaucoma or implantable ophthalmic medical devices
• Preferred: Experience with European medical device clinical development and MDR clinical documentation
• Preferred: Experience managing CROs, laboratories, investigators and academic partners
• Preferred: Previous line-management responsibility in a clinical, scientific or R&D function
• Preferred: Hands-on experience with data mining, numerical simulation or translational research
• Preferred: Scientific expertise in glaucoma pathophysiology, aqueous humour outflow or glaucoma surgery

• Fully remote work arrangement
• Ability to work regularly from the office for candidates based in France
• Regular European travel and occasional international travel as required
• Scientific and professional development through clinical studies, collaborations, meetings, laboratories, scientific meetings and congresses