Principal Clinical Scientist

Abbott • Temecula, SC

14d • $112,000 - $224,000 • Onsite

About The Position

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career of which you dream. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. 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. The Opportunity This position may work out of any of our Vascular Division sites: Santa Clara, CA, Temecula, CA, St. Paul, MN, Westford, MA. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION.

Requirements

• Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred.
• Minimum of 8+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience.
• Comprehensive knowledge of a particular technological field.
• Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships
• Recognized as an expert in work group and across functions.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Nice To Haves

• MS Office Suite, highly preferred
• Experience in the medical device industry, highly preferred
• Experience with clinical trials, highly desirable
• Experience in a vascular/cardiovascular fields, a plus

Responsibilities

• Design clinical trials and studies in collaboration with internal stake holders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs, medical affairs as well as external stake holders including steering committees, and national principal investigators to support device premarket approval (PMA) applications and premarket notification submissions (510(k)) to the FDA, and strategic business needs.
• Provide scientific and technical direction and feedback.
• Provide scientific leadership to Cross Functional and Marketing/Commercial Teams to support business priorities and serve as Clinical Science lead on study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information, including pre-submissions to FDA.
• Lead the generation of study-related documents and/or contribute content and oversight of such documents, including, clinical study protocols, case report forms, clinical study reports, and informed consent forms.
• Critically analyze data and present to internal and external groups including but not limited to clinicians and cross-functional team members.
• Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy.
• Lead/collaborate on submission of abstracts, presentations, and publications of clinical study data, working with investigator authors and internal teams.
• Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area.
• Review and critically assess statistical analysis plans.
• Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions.
• Attend, present at, and lead meetings with FDA and other regulatory bodies.
• Contribute to the optimization of internal processes and workflows.
• Develop new ideas for both external and internal projects.
• Mentor junior team members.
• Perform other related duties and responsibilities, on occasion, as assigned.

Benefits

• Career development with an international company where you can grow the career of which you dream.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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.

What This Job Offers

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