Senior Clinical Research Scientist

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Senior Clinical Research Scientist

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution.

• Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

This position works out of our Plymouth, MN location, in the Electrophysiology division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives.

The Senior Clinical Research Scientist will provide scientific leadership for clinical research programs supporting product development, regulatory approvals, post-market evidence generation, and scientific communication activities. This individual will lead scientific activities associated with the design, execution, analysis, interpretation, and reporting of clinical studies and will serve as a key scientific partner across multiple cross-functional initiatives.

What You'll Work On

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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Apply Now (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/ (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com , on LinkedIn at https://www.linkedin.com/company/abbott-/ , and on Facebook at https://www.facebook.com/AbbottCareers .

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]