Senior Clinical Research Scientist

Abbott • Plymouth, MN

19h • $78,000 - $156,000 • Onsite

About The Position

The Senior Clinical Research Scientist works in Abbott’s Electrophysiology division at its Plymouth, Minnesota location. The role provides scientific leadership for clinical research supporting product development, regulatory approvals, post-market evidence generation, and scientific communications. The scientist leads the design, execution, analysis, interpretation, and reporting of clinical studies and serves as a scientific partner across cross-functional initiatives.

The position collaborates with Clinical Program Directors, project management, Clinical Operations, biostatistics, data management, quality, regulatory affairs, reimbursement, health economics, Medical Affairs, and R&D. The scientist manages complex scientific initiatives while ensuring compliance with applicable regulations and quality system requirements. The role also supports evidence packages for regulatory submissions, publication activities, inspection readiness, investigator and physician relationships, and the development of long-term evidence-generation strategies.

Requirements

• Bachelor’s degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or a related scientific discipline.
• Relevant experience equivalent to BS plus 7–10 years, MS plus 5–8 years, or PhD plus 2–5 years.
• 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 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 scientific manuscripts, abstracts, posters, podium presentations, and other scientific communications.
• Experience contributing to publication planning and coordinating scientific deliverables with internal and external stakeholders.
• Experience supporting clinical evidence packages 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.

Nice To Haves

• Advanced degree.
• 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 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.

Responsibilities

• 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 that support global regulatory and business objectives.
• Serve as scientific lead for assigned clinical studies and provide scientific direction throughout study planning, execution, analysis, and reporting.
• Develop scientific rationale for 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.
• Evaluate and interpret 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 and lead abstracts, manuscripts, posters, podium presentations, and publication committee activities.
• Author or contribute scientifically to 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 for FDA, PMA, MDR, PMDA, NMPA, and Health Canada submissions.
• Develop responses to regulatory authority questions about 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 scientifically review protocols, reports, publications, and presentations.
• Support Clinical Program Directors in developing and executing long-term evidence-generation strategies.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, providing an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior