Senior Clinical Research Scientist

This position will work closely with Clinical Program Directors, project management, clinical operations, biostatistics, data management, quality, regulatory affairs, reimbursement, health economics, medical affairs, and R&D teams. The individual will be expected to manage complex scientific initiatives while ensuring compliance with applicable regulations and quality system requirements. Additionally:

• Lead development of clinical study protocols, protocol amendments, investigator brochures, case report forms, statistical assumptions, endpoint strategies, and clinical study reports.
• Design prospective clinical studies, registries, observational studies, post-market studies, and evidence-generation programs supporting global regulatory and business objectives.
• Serve as scientific lead for assigned clinical studies and provide strategic scientific direction throughout study planning, execution, analysis, and reporting.
• Develop scientific rationale supporting study design, endpoint selection, inclusion and exclusion criteria, evidence-generation strategies, and clinical development plans.
• Collaborate with biostatistics to review statistical analysis plans and interpret primary, secondary, subgroup, sensitivity, and safety analyses.
• Lead scientific evaluation and interpretation of clinical data and translate findings into clinically meaningful conclusions.
• Partner with Clinical Operations and CRO teams to address enrollment challenges, protocol deviations, operational risks, data quality concerns, and other study-execution issues.
• Develop publication strategies supporting clinical programs and lead execution of abstracts, manuscripts, posters, podium presentations, and publication committee activities.
• Serve as an author or scientific contributor on peer-reviewed publications and scientific communications.
• Present scientific findings to investigators, steering committees, publication committees, internal leadership, and external stakeholders.
• Support development of clinical evidence packages used in FDA, PMA, MDR, PMDA, NMPA, and Health Canada submissions.
• Develop responses to questions from regulatory authorities related to clinical evidence and study outcomes.
• Support inspection readiness, audit activities, and quality system compliance initiatives.
• Build and maintain productive relationships with investigators, physician leaders, and key opinion leaders.
• Mentor junior scientists and provide scientific review of protocols, reports, publications, and presentations.
• Support Clinical Program Directors in development and execution of long-term evidence-generation strategies.

• Bachelor's degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or related scientific discipline.
• Minimum experience equivalency:
  • BS + 7-10 years relevant experience
  • MS + 5-8 years relevant experience
  • PhD + 2-5 years relevant experience

• Demonstrated scientific writing ability.
• Experience designing, conducting, analyzing, and reporting clinical research studies supporting product development, regulatory submissions, post-market surveillance, and evidence-generation initiatives.
• Experience contributing to the development of clinical study protocols, protocol amendments, clinical study reports, investigator brochures, case report forms, and other key clinical study documentation.
• Experience supporting prospective clinical trials, registries, observational studies, post-market studies, or other clinical evidence-generation activities.
• Experience interpreting clinical data and statistical analyses, including study endpoints, subgroup analyses, safety analyses, and benefit-risk assessments.
• Experience authoring or leading development of scientific manuscripts, abstracts, posters, podium presentations, and other scientific communications.
• Experience contributing to publication planning activities and coordinating scientific deliverables with internal and external stakeholders.
• Experience supporting development of clinical evidence packages used for regulatory submissions, clinical evaluations, reimbursement initiatives, or responses to regulatory authorities.
• Working knowledge of clinical research regulations and standards including ICH-GCP, ISO, FDA regulations, EU MDR requirements, HIPAA, and GDPR.
• Experience collaborating with cross-functional teams including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Quality, and Research & Development.
• Experience communicating scientific information to investigators, key opinion leaders, study teams, and cross-functional stakeholders.
• Ability to independently manage multiple scientific priorities while supporting complex clinical research programs.

• Advanced degree preferred.
• Medical device clinical research experience.
• Electrophysiology and cardiovascular medical device experience.
• Experience leading global clinical trials or investigator-sponsored research.
• Experience supporting PMA, MDR, PMDA, NMPA, and Health Canada submissions.
• Experience leading publication planning and publication execution activities.
• Experience presenting scientific information to investigators, KOLs, and executive leadership.
• Prior mentoring or scientific leadership experience.
• Experience reviewing statistical analysis plans and interpreting complex clinical datasets.

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In specific locations, the pay range may vary from the range posted.