Principal Clinical Scientist at Abbott

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, VascularIndustries

Requirements

Advanced degree in a relevant scientific field (implied by role level and responsibilities such as designing clinical trials and providing scientific leadership)

Responsibilities

Design clinical trials and studies in collaboration with internal stakeholders (clinical project management, clinical operations, biostatistics, data management, regulatory affairs, medical affairs) and external stakeholders (steering committees, national principal investigators) to support device premarket approval (PMA) applications, 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; 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 and pre-submissions to FDA)
Lead the generation of study-related documents and/or contribute content and oversight, 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 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 as assigned

Skills

Clinical Trial Design

Biostatistics

Data Management

Regulatory Affairs

Medical Affairs

Clinical Operations

Project Management

Steering Committees

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees