Principal Clinical Research Scientist

Abbott Laboratories • Plymouth, MN

1d • Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life, with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines. The company has 115,000 colleagues serving people in over 160 countries. In Abbott’s Electrophysiology (EP) business, the focus is on advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation. This Principal Clinical Research Scientist position is based in St. Paul, MN, supporting the Electrophysiology medical device division. The role involves leading scientific activities related to the design, conduct, and reporting of clinical trials for this therapeutic area. The scientist will contribute to developing clinical evidence for feasibility, regulatory approvals, ongoing regulatory requirements, reimbursement, and commercial adoption of medical devices. Key tasks include supporting scientific data analysis and interpretation, writing clinical study protocols, reports, and scientific publications, and aiding in the production of study-level documents like informed consent forms, case report forms, and investigator brochures. The role requires interaction with physician Key Opinion Leaders, various cross-functional teams (Marketing, R&D, Field Operations, Risk Management, Reimbursement, Medical Affairs, Quality, Regulatory Affairs), global regulatory agencies for market approval, and study sites for ongoing support.

Requirements

• Advanced degree in the sciences, medicine, or similar discipline.
• 5+ years of clinical science experience post-degree.
• Demonstrated scientific writing ability.
• Experience with international medical device regulations and submissions.
• Ability to plan and organize project assignments of substantial variety and complexity.
• Ability to be innovative, resourceful, and work with minimal direction.
• Excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams.
• Ability to work within a team in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Strong organizational and follow-up skills, as well as attention to detail.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Nice To Haves

• PhD degree in the sciences, medicine, or similar discipline preferred.
• Experience in the medical device industry.
• Familiarity with relevant international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
• Experience working in a quality system environment preferred.

Responsibilities

• Develops, writes or mentors others in clinical trial design, protocol development, and publication planning.
• Develops, writes or mentors others in generating and executing on study-level publication projects.
• Develops, writes, or mentors others in generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study reports, clinical study protocols, case report forms, investigational brochures, and informed consent forms.
• Review and critically analyze statistical analysis plans.
• Support regulatory submissions.
• Facilitate communication between Sales and Marketing, R&D, Program Management, Reimbursement, Medical Affairs, Risk Management, Quality and Regulatory Affairs, and investigational sites.
• Oversee study Steering Committees and Publication Committees, consisting of physician Key Opinion Leaders globally.
• Present clinical study results to senior leaders and at investigator meetings.
• Participate in and support audits.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
• Health and wellness benefits, which provide the security to help you and your family live full lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees