Principal Clinical Scientist

1w1 week ago

Abbott

Santa Clara, US · Full-time · $114,000 – $228,000

About this role

Abbott is a global healthcare leader with life-changing technologies in diagnostics, medical devices, nutritionals, and medicines. Our Vascular Division in Santa Clara seeks a Principal Clinical Scientist for a fully onsite role. Abbott Vascular offers innovative products like drug-eluting stents, guide wires, and vessel closure devices for vascular disease.

Design clinical trials and studies with internal stakeholders including clinical operations, biostatistics, regulatory affairs, and external groups like steering committees. Provide scientific leadership to cross-functional and commercial teams on study teams. Support premarket approval applications and 510(k) submissions to the FDA.

Collaborate with clinical project management, data management, medical affairs, and national principal investigators. Lead generation of study documents such as protocols, case report forms, clinical study reports, and informed consents. Generate regulatory submission documents and respond to authority questions.

Critically analyze data and present to clinicians, cross-functional teams, and external groups. Develop scientific podium and publication strategy with cross-functional partners. Join 115,000 colleagues serving people in over 160 countries.

At Abbott, pursue career development in an international company, qualify for free medical coverage via Health Investment Plan, and access excellent retirement savings. Benefit from tuition reimbursement, Freedom 2 Save student debt program, and FreeU education path to a bachelor's degree. Recognized as a great place to work globally by Fortune.

Requirements

Expertise in clinical trial design for medical device premarket approval (PMA) and 510(k) submissions
Knowledge of FDA regulatory processes and requirements for vascular devices
Experience collaborating with biostatistics, data management, and regulatory affairs
Proficiency in generating clinical study protocols, case report forms, and study reports
Skills in critical data analysis and scientific presentation to clinicians
Background in vascular disease treatments and minimally invasive technologies
Ability to lead cross-functional teams and external steering committees

Responsibilities

Design clinical trials and studies in collaboration with internal stakeholders including clinical project management, clinical operations, biostatistics, data management, regulatory affairs, medical affairs and external stakeholders including steering committees, and national principal investigators
Provide scientific and technical direction and feedback to support business priorities
Provide scientific leadership to Cross Functional and Marketing/Commercial Teams and serve as Clinical Science lead on study teams
Lead the generation of study-related documents including clinical study protocols, case report forms, clinical study reports, and informed consent forms
Generate documents to support regulatory submissions for Abbott products and respond to questions from regulatory authorities
Critically analyze data and present to internal and external groups including clinicians and cross-functional team members
Develop the scientific podium and publication strategy in close collaboration with cross-functional partners

Benefits

Career development with an international company
Qualify for free medical coverage in Health Investment Plan (HIP) PPO medical plan
Excellent retirement savings plan with high employer contribution
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit
Recognized as a great place to work in dozens of countries and one of the most admired companies by Fortune
Best big company to work for, including for diversity, working mothers, female executives, and scientists