Head of Clinical Research Science

The aim of the Head of Clinical Research Science is to lead Ciliatech’s European clinical and research activities and strengthen the scientific understanding of Ciliatech’s technology and products.

Location: Preference for candidates based in France, ideally in Lyon with the ability to work regularly from our office. Remote working can also be considered for candidates based in France, the UK or Germany.

Mobility: Ability to travel independently as required for clinical studies, scientific collaborations and meetings with external partners.

Travel readiness: This role involves regular European travel, including visits to clinical sites, investigators, laboratories, scientific meetings and congresses. Occasional international travel may also be required.

RESPONSIBILITIES

Scientific Research & Evidence Strategy

• Develop and continuously strengthen the scientific understanding of Ciliatech’s technology and products, including mechanism of action, performance limits and opportunities for improvement

• Identify scientific and clinical knowledge gaps, unexplained outcomes and factors potentially influencing product performance and clinical outcomes

• Conduct and synthesise scientific literature reviews, data mining and quantitative analyses to support clinical development, new indications, surgical technique development and product design decisions

• Formulate scientific hypotheses and propose evidence-generation plans using literature, existing clinical data, targeted preclinical work, numerical simulations and prospective clinical investigations

• Design and coordinate occasional preclinical research activities, including objectives, methodologies, protocols, laboratory selection and report review

• Translate scientific, preclinical and clinical findings into clear recommendations for R&D, Clinical, Medical, Regulatory and Company leadership

Clinical Development Oversight

• Provide strategic and scientific oversight of Ciliatech-sponsored European clinical studies, beginning with Safari Next

• Define or review study concepts, scientific rationale, objectives, endpoints and key protocol assumptions in collaboration with the Senior Project Manager and relevant experts

• Ensure clinical execution remains aligned with scientific objectives, evidence needs and Company priorities

• Review study progress, emerging data, risks and major scientific or operational issues, and provide recommendations or escalation when required

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

Scientific Evidence & Product Performance

• Maintain an integrated view of the scientific, preclinical and clinical evidence supporting Ciliatech’s products

• Investigate factors influencing 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

Clinical & Regulatory Documentation

• 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 other regulatory stakeholders

Team Management

• Lead the European clinical and research function and define roles, priorities and resource needs within approved plans

• Provide line management and strategic direction to the Senior Project Manager and other assigned clinical personnel or contractors

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

Profile

Required Skills/Experience

• 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

Preferred Skills/Experience

• PhD, PharmD, MD or equivalent advanced scientific degree, preferably in ophthalmology, glaucoma, medical devices or biomedical research

• Experience in glaucoma or implantable ophthalmic medical devices

• Experience with European medical device clinical development and MDR clinical documentation

• Experience managing CROs, laboratories, investigators and academic partners

• Previous line-management responsibility in a clinical, scientific or R&D function

• Hands-on experience with data mining, numerical simulation or translational research

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