Principal Clinical Research Scientist

Principal Clinical Research Scientist

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. 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.

What You'll Work On

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

The base pay for this position is $99,300.00 $198,700.00. In specific locations, the pay range may vary from the range posted.