Senior Clinical Research Scientist
Abbott Laboratories
Summary
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.
Job description
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.
- 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.
Requirements
- 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.
Benefits
- Free medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare technology leader founded in 1888 and headquartered in Chicago, Illinois. As an international medtech and pharmaceutical company, Abbott operates in approximately 160 countries worldwide with a workforce of over 115,000 employees. The company is organized into four major business segments: Medical Devices (48% of revenue), Diagnostics (20%), Nutritional Products (19%), and Established Pharmaceutical Products (12%). Abbott's medical devices portfolio includes revolutionary technologies such as the FreeStyle Libre continuous glucose monitoring system for diabetes management, cardiovascular devices like the MitraClip and TriClip for heart valve repair, and neuromodulation systems for chronic pain management. The company's diagnostics division pioneered breakthrough tests including the first licensed HIV blood test in 1985. With a rich history spanning over 135 years, Abbott has consistently been recognized as one of Fortune's World's Most Admired Companies since 1984 and continues to drive innovation in healthcare technology to help people live healthier, fuller lives.