Principal Clinical Scientist

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

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 you dream of.
• 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

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Santa Clara, CA, currently has an opportunity for a Principal Clinical Scientist to join our ONSITE Clinical Science team

What You’ll Work On

• 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.
• Provides scientific and technical direction and feedback. Provides scientific leadership to Cross Functional and 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.
• Leads 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 analyze 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 leads 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
• Performs other related duties and responsibilities, on occasion, as assigned

 

Required Qualifications

• 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 fie