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

Key technologies and capabilities for this role

Clinical Trial DesignBiostatisticsData ManagementRegulatory AffairsMedical AffairsClinical OperationsProject ManagementSteering Committees

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott offers free medical coverage through the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this position remote or onsite?

This is an onsite daily required position that may work out of Abbott Vascular Division sites in Santa Clara, CA, Temecula, CA, St. Paul, MN, or Westford, MA.

What are the main responsibilities of the Principal Clinical Scientist?

Responsibilities include designing clinical trials in collaboration with stakeholders, providing scientific leadership to teams, leading generation of study documents like protocols and reports, critically analyzing data, and presenting to internal and external groups.

What is Abbott's company culture like?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this Principal Clinical Scientist role?

Strong candidates should have expertise in designing clinical trials for medical devices, experience collaborating with cross-functional teams like biostatistics and regulatory affairs, ability to provide scientific leadership, and skills in data analysis and FDA submission support.

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