Principal Clinical Research Scientist

Abbott • Plymouth, MN

1d • Onsite

About The Position

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 115,000 colleagues serve people in more than 160 countries. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. This position works out of our St. Paul, MN location, supporting our Electrophysiology medical device division. The Principal Clinical Research Scientist will lead scientific activities associated with the design, conduct, and reporting of clinical trials for this therapeutic area. This position will participate in the development of clinical evidence to establish feasibility, achieve regulatory approvals, meet ongoing regulatory requirements, gain reimbursement, and support full commercial adoption of medical devices. You will support the analysis and interpretation of scientific data and write clinical study protocols, reports, and scientific publications. You will aid in the production of additional study-level documents including informed consent forms, case report forms, and investigator brochures. In this role, you will interact with physician Key Opinion Leaders and various cross-functional teams, including Marketing, R&D, Field Operations, Risk Management, Reimbursement, Medical Affairs, Quality, and Regulatory Affairs. You will also interact with global regulatory agencies to obtain market approval of new products, and with study sites to respond to questions throughout the study.

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