Head of Clinical Research Science

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🔥 6 minutes ago

🌐 France, United Kingdom, +1 more countries – Remote

🇫🇷 France – Remote 🇬🇧 United Kingdom – Remote 🇩🇪 Germany – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 13%

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CILIATECH - Glaucoma Innovators

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $1.9M Debt Financing - Ciliatech on 2023-04

Healthcare • Consulting • Manufacturing

CILIATECH - Glaucoma Innovators is a medical technology company that develops the Intercil® Uveal Spacer, an implantable supraciliary device designed to lower intraocular pressure in primary open-angle and angle-closure glaucoma. The company emphasizes an ab-externo, bleb-free surgical approach that avoids entry into the anterior chamber, aiming to reduce endothelial cell risk and postoperative burdens while preserving future surgical options. CILIATECH supports its product with multi-year clinical trials and targets ophthalmic surgeons and professional audiences in glaucoma care.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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