Head of Clinical Research Science

This is a fully remote position, open to applicants in France, +2 more countries.

📋 Description

• Oversee Ciliatech's clinical and research initiatives across Europe.

• Enhance the scientific comprehension of Ciliatech's technologies and products.

• Create and incorporate scientific, preclinical, and clinical evidence for product performance, clinical development, new indications, and product development decisions.

• Provide strategic and scientific oversight for Ciliatech-sponsored clinical studies in Europe.

• Collaborate across Research & Development, Clinical, Medical, Quality, and Regulatory functions.

• Execute and synthesize literature reviews, data mining, and quantitative analyses.

• Identify gaps in scientific and clinical knowledge, unexplained outcomes, and factors affecting product performance and clinical results.

• Develop scientific hypotheses and propose plans for evidence generation.

• Design and manage occasional preclinical research activities.

• Translate scientific, preclinical, and clinical findings into actionable recommendations for leadership and functional teams.

• Define or evaluate study concepts, scientific rationale, objectives, endpoints, and protocol assumptions.

• Monitor study progress, emerging data, risks, and scientific or operational challenges.

• Analyze and interpret clinical study results in collaboration with scientific, medical, statistical, and regulatory experts.

• Maintain a consolidated body of scientific, preclinical, and clinical evidence supporting products.

• Investigate aspects such as patient selection, surgical techniques, 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 the clinical sections of technical documentation for CE marking support.

• Prepare or assist with Clinical Evaluation, PMCF, and other relevant MDR clinical documentation.

• Provide scientific and clinical insights for inquiries from Notified Bodies and regulatory stakeholders.

• Lead the European clinical and research division; define roles, priorities, and resource requirements.

• Offer line management and strategic guidance to the Senior Project Manager and designated clinical personnel or contractors.

• Coordinate interactions across Research & Development, Clinical, Medical, Quality, and Regulatory functions.

⛳️ Requirements

• Advanced degree in life sciences, biomedical sciences, medicine, pharmacy, engineering, or a related scientific discipline.

• Extensive senior-level experience in scientific research, clinical research, and/or medical device development.

• Strong expertise in ophthalmology.

• Experience in developing scientific hypotheses and analyzing scientific, preclinical, and clinical data.

• Background in designing or overseeing clinical and/or preclinical studies.

• Proven ability to work cross-functionally with R&D, Clinical, Medical, Quality, and Regulatory teams.

• Experience in leading clinical or scientific professionals and managing external partners.

• Strong skills in scientific reasoning, literature review, and hypothesis-driven research.

• Ability to analyze and interpret scientific, preclinical, and clinical data, including basic biostatistical outputs.

• Comprehensive understanding of clinical research methodologies and study design.

• Excellent scientific and technical writing and presentation abilities.

• Familiarity with Good Clinical Practice, ISO 14155, and relevant European clinical research regulations.

• Knowledge of EU MDR, Clinical Evaluation, and PMCF requirements.

• Capable of strategic leadership, prioritization, delegation, and personnel management.

• Ability to lead through influence with employees, contractors, and external experts.

• Proficient in English.

• Willingness to travel independently for clinical studies, scientific collaborations, and meetings with external partners.

• Regular readiness for travel within Europe.

• Preferred: PhD, PharmD, MD, or equivalent advanced scientific degree, ideally 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 collaborators.

• Preferred: Previous line-management experience in a clinical, scientific, or R&D setting.

• Preferred: Practical experience with data mining, numerical simulation, or translational research.

• Preferred: Scientific expertise in glaucoma pathophysiology, aqueous humour outflow, or glaucoma surgery.

🏝️ Benefits

• Fully remote work arrangement.

• Option to work regularly from the office for candidates located in France.

• Regular travel within Europe and occasional international travel as required.

• Opportunities for scientific and professional development through clinical studies, collaborations, meetings, laboratories, scientific conferences, and congresses.