Senior Clinical Research Scientist M/F/X

Tissium is a mission-driven medical device company founded in 2013, headquartered in Paris, with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop innovative solutions in surgery for a positive impact on patients' lives.

Tissium's technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital), who co-founded the company with Christophe Bancel (CEO) and Maria Pereira (Deputy CEO & Chief Innovation Officer).

We are developing polymers for atraumatic tissue repair in various applications. Today, these polymers are used for sutureless nerve repair, hernia repair, and cardiovascular sealing.

Since our inception, we have raised more than 200 million euros, including 60 million euros in new financing announced in June 2026. This capital supports the US commercial rollout of COAPTIUM® CONNECT, our FDA-authorized sutureless nerve repair system, and the development of our pipeline.

ROLE SUMMARY

As TISSIUM moves from development to commercial stage, with COAPTIUM® CONNECT rolling out in the US and a pipeline spanning nerve, hernia and cardiovascular applications, robust clinical evidence is at the heart of our growth. The Senior Clinical Research Scientist is a key member of the Global Clinical Affairs team and owns the scientific and clinical content behind our clinical evaluations, studies and regulatory submissions, working closely with Clinical Operations, Regulatory Affairs, Quality, R&D, Marketing, CROs and investigators. This is an opportunity to shape the clinical evidence strategy of a fast-growing medtech and to take on growing scope as the portfolio expands.

RESPONSIBILITIES

• Author and maintain clinical evaluation documentation (CEP, CER, PMCF plans and reports, SSCP) in line with EU MDR and FDA expectations.

• Write study protocols, amendments, informed consent forms, clinical study reports and scientific publications.

• Run systematic literature reviews and appraise clinical, scientific and risk data against the current state of the art.

• Define end-to-end analysis plans: study populations, analytical models, outcomes and interpretation.

• Analyze clinical data and turn results into clear figures, summaries and recommendations.

• Contribute to clinical strategy and study design with Clinical Affairs, R&D, Regulatory Affairs and Marketing.

• Feed clinical inputs into risk management files and post-market surveillance activities.

• Support regulatory submissions and represent Clinical Affairs in interactions with notified bodies and health authorities, alongside Regulatory Affairs.

• Present clinical results to senior leadership, investigators, and at scientific and industry meetings.

• Manage timelines and budgets for clinical evaluations and studies, including selection and oversight of CROs and external medical writers.

• Support audits, CAPA and continuous improvement of clinical SOPs.

• Mentor junior team members and share scientific expertise across the team.

QUALIFICATIONS & SKILLS

• Master's degree in life sciences, biomedical engineering or a related field (required); PhD, PharmD or MD strongly preferred.

• 5+ years of experience in clinical research, clinical evaluation or medical writing, or a PhD/MD with 2+ years of relevant industry experience (required).

• Hands-on authoring of CEPs/CERs under EU MDR 2017/745 (MEDDEV 2.7/1 rev. 4, MDCG guidance) (required).

• Medical device industry experience (strongly preferred); pharma or CRO backgrounds welcome.

• Working knowledge of ISO 14155 / GCP and ISO 14971; exposure to FDA submissions a plus.

• Independent data analysis and programming skills (R, SAS, Python or similar) and a solid grasp of statistical principles (required).

• Strong data visualization and scientific writing skills; peer-reviewed publications a plus.

• Fluent English, written and spoken (required); [French a plus / required: to be confirmed].

WHAT MAKES YOU A GREAT FIT

• Scientific rigor — you build conclusions on data and challenge weak evidence.

• Clear communicator — you make complex results simple for clinicians, regulators and executives.

• Ownership — you drive deliverables end to end and anticipate risks to timelines.

• Collaborative — you build trust across functions, with CROs and with investigators.

• Pragmatic — you balance regulatory requirements with the pace of a growing company.

• Mentor mindset — you enjoy helping others grow and raising the bar for the team.

• Patient-driven — you are motivated by improving patients' quality of life.

Reports to Director, Clinical Science

WHY JOIN US

• Thrive in a stimulating environment with a work culture that values urgency, a willingness to take risks, a passion for learning, the ability to challenge the status quo, and the agility to operate in a dynamic setting.

• Grow your career: At TISSIUM, we invest in our people through tailored training and professional development programs. We believe in offering diverse learning methods to help each team member flourish in their career journey.

• Be part of an ambitious start-up tackling one of the most persistent medical challenges since the advent of surgical procedures.

• Work with purpose: Environmental, Social, and Governance (ESG) principles have been embedded in our business model from the very beginning. As we grow, strengthening and advancing our ESG strategy and commitments remains a top priority.

• Join a truly international team: Collaborate with colleagues from over 19 nationalities, reflecting TISSIUM's commitment to diversity and the strength it brings to our work.

HIRING PROCESS

• A 30-minute interview with our Talent Acquisition manager.

• A one-hour interview with the hiring manager.

• A technical interview to explore your clinical and scientific expertise.

• A final culture fit interview with the team and key stakeholders.

Intrigued? We'd love to hear from you! Apply today - we're standing by for your resume!

👉 We believe that building an inclusive company starts with a diverse team. We value diversity and encourage applications from people of all backgrounds. We are committed to equal opportunity and do not tolerate discrimination of any kind, including on the basis of gender, gender identity or expression, sexual orientation, origin, family situation, age, beliefs, disability, health status, or any other characteristic protected by law.

Our recruitment process is designed to be simple, transparent, and conversation-driven. We prioritize human interaction and ensure that every application is reviewed carefully and fairly.