Clinical Scientist

Summary Description

The Clinical Scientist supports the planning and execution of clinical evidence programs for products across the Tissue Reconstruction portfolio. This role contributes to study design, protocol development, study execution, data analysis, and interpretation of clinical and real-world data to support regulatory, medical, commercial, and market access objectives. The scientist works closely with Clinical Development leadership within Medical Affairs and collaborates cross-functionally with downstream Medical Affairs colleagues, as well as Regulatory Affairs, Clinical Operations, Biostatistics, R&D, Marketing, Market Access, and external clinical partners to generate evidence supporting product development, regulatory submissions, clinical claims, scientific communications, reimbursement initiatives, and evidence-based decision-making across the product lifecycle. In addition to traditional clinical studies, the role may contribute to real-world evidence, registry, health economics, outcomes research, and claims-based research initiatives.

Key Responsibilities

• Contribute to the development and execution of clinical evidence strategies supporting products across the Tissue Reconstruction portfolio.
• Conduct literature reviews, evidence gap assessments, and scientific landscape analyses to inform evidence-generation priorities.
• Lead the scientific design of assigned studies and contribute to the development of protocols, data collection instruments, analysis plans, and study reports in collaboration with Clinical Operations, Medical Communications, and Biostatistics.
• Design, plan, and execute clinical studies, registries, real-world evidence, outcomes research, and claims-based research initiatives.
• Lead assigned study and evidence-generation workstreams with accountability for timelines, deliverables, study quality, and execution.
• Analyze, interpret, and synthesize clinical, real-world, health economics, and published data to generate scientific insights regarding evidence gaps, competitive evidence evaluations, and landscape analyses to inform clinical development and evidence strategy.
• Contribute to scientific publications, conference presentations, and other evidence dissemination activities.
• Present scientific findings and evidence-based recommendations to internal stakeholders and cross-functional teams.
• Collaborate with Medical Affairs, Regulatory Affairs, Clinical Operations, Biostatistics, R&D, Marketing, Market Access, and external investigators to align evidence-generation activities with product development and business needs.
• Support investigator and KOL collaborations through study planning discussions, advisory activities, and investigator-initiated research programs.

Desired Minimum Qualifications

• Advanced degree required (Master's minimum; Ph.D. preferred) in Biomedical Engineering, Biomaterials, Tissue Engineering, Regenerative Medicine, Biological Sciences, Public Health, Epidemiology, Health Outcomes Research, or a related scientific discipline.
• Minimum of 3 years of relevant experience in clinical development, clinical research, medical affairs, epidemiology, health outcomes, real-world evidence, or related evidence-generation functions.
• Experience supporting clinical studies, registries, real-world evidence (RWE), outcomes research, health economics, or claims-based research projects preferred.
• Experience within the medical device or biotechnology industry preferred.
• Demonstrated academic training, research experience, or scientific expertise in biomaterials, tissue engineering, regenerative medicine, wound healing, tissue repair, soft-tissue reconstruction, or related fields strongly preferred.
• Experience developing scientific communications, including manuscripts, abstracts, posters, presentations, reports, or literature reviews preferred.

Technical Competencies

• Strong analytical, critical-thinking, and scientific problem-solving skills.
• Knowledge of clinical research methodology, study design, and evidence-generation principles.
• Understanding of biostatistics and experience interpreting clinical, real-world, and published data.
• Ability to apply scientific understanding of biomaterials, tissue remodeling, and regenerative mechanisms to clinical evidence generation, study design, data interpretation, and scientific communications.
• Ability to synthesize complex clinical and scientific information into clear, actionable insights and recommendations.
• Ability to conduct literature reviews, evidence gap assessments, scientific landscape analyses, and evidence synthesis activities.
• Proactive, self-motivated, and results-oriented with a strong commitment to execution excellence.
• Familiarity with real-world evidence, outcomes research, registry, claims-based, and health economics research methodologies.
• Effective project management and organizational skills, with the ability to manage multiple priorities and deadlines.
• Strong scientific writing skills with the ability to support publications, abstracts, study reports, and scientific presentations.
• Excellent collaboration skills and demonstrated success working in a cross-functional, matrixed environment.
• Ability to build productive relationships with internal stakeholders, external investigators, and research partners.
• Excellent written, verbal, and presentation communication skills.
• Experience working with clinical, real-world, registry, or claims data and utilizing analytical or data visualization tools (e.g., Excel, R, SAS, SQL, Power BI, Tableau, or similar).