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Principal Clinical Research Scientist

5 years
Not Disclosed
10 Nov. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Clinical Research Scientist

Category: Medical and Clinical Affairs
Locations: St. Paul or Plymouth (MN), Austin (TX), Santa Clara (CA) – United States

About the Company

Abbott is a global healthcare leader committed to advancing medical science and improving health outcomes worldwide. With a diverse portfolio spanning diagnostics, medical devices, nutrition, and branded generic medicines, Abbott serves patients in more than 160 countries. The organization continues to innovate across all stages of healthcare, contributing to meaningful, life-changing advancements.

Role Overview

The Principal Clinical Research Scientist plays a strategic role in leading scientific, clinical, and regulatory activities essential for successful medical device development. This position supports Abbott’s Electrophysiology division, contributing to the design, execution, and reporting of clinical trials that advance therapeutic solutions for cardiac arrhythmia and related conditions.

This role requires strong scientific expertise, advanced research experience, and the ability to collaborate across cross-functional teams, including R&D, Marketing, Medical Affairs, Regulatory Affairs, Field Operations, and global regulatory authorities.

Key Responsibilities

Clinical Research Strategy and Documentation

  • Lead or mentor clinical trial design, protocol development, and publication strategy.

  • Author and review clinical protocols, study reports, case report forms, investigator brochures, and informed consent documents.

  • Develop and execute study-level publication plans and scientific communications.

  • Analyze scientific and statistical data; review statistical analysis plans.

  • Participate in the development and interpretation of clinical evidence to support feasibility, regulatory approval, reimbursement, and commercial adoption.

Cross-Functional Collaboration

  • Partner with physician Key Opinion Leaders (KOLs), clinical investigators, and external stakeholders.

  • Lead collaboration with internal functions including Quality, Risk Management, R&D, Reimbursement, Marketing, and Program Management.

  • Support interactions with global regulatory bodies for market approval submissions.

  • Provide scientific leadership to Steering Committees and Publication Committees.

Operational and Compliance Responsibilities

  • Present clinical data to senior leadership and stakeholders.

  • Support clinical study audits and ensure adherence to internal and external regulatory standards.

  • Offer guidance and insights throughout the clinical trial lifecycle, ensuring high-quality data generation and study performance.

Required Qualifications

  • Advanced degree (Master's or equivalent) in science, medicine, or related discipline.

  • Minimum 5 years of post-degree clinical science experience.

  • Proven scientific writing expertise with a strong portfolio of publications or study documents.

  • Experience working with international medical device regulations and submissions.

  • Strong project planning, analytical thinking, and problem-solving capabilities.

  • Demonstrated ability to work independently and within cross-functional teams in a fast-paced environment.

  • Excellent communication skills with the ability to engage stakeholders at multiple organizational levels.

  • High attention to detail, organizational discipline, and ability to manage complex clinical projects.

Preferred Qualifications

  • PhD in sciences, medicine, or a related field.

  • Clinical research experience in the medical device industry.

  • Familiarity with global medical device regulatory requirements and Quality Systems standards.

  • Experience working within a regulated quality system environment.

Why Work at Abbott

  • Comprehensive career development opportunities within a leading global organization.

  • Free medical coverage for employees under the Health Investment Plan (HIP) PPO (after completing a wellness assessment).

  • Highly competitive retirement savings plans with robust employer contributions.

  • Tuition reimbursement programs, student debt support (Freedom 2 Save), and FreeU education pathways.

  • Recognized globally as a top employer across diversity, innovation, and workplace culture.