Principal Clinical Scientist

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.

• Design clinical trials and studies in collaboration with internal stakeholders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs, medical affairs as well as external stakeholders including steering committees, and national principal investigators to support device pre‑market approval (PMA) applications and pre‑market 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.

Education and Experience You’ll Bring

Required Qualifications

Preferred Qualifications

Please note that the salary range listed is our full grade range. We usually hire based on the mid‑point.

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