Abbott

Principal Clinical Scientist

Abbott

full-time

Posted on:

Location Type: Office

Location: Temecula • California • Massachusetts • United States

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Salary

💰 $99,300 - $198,700 per year

Job Level

Lead

About the role

  • 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 premarket approval (PMA) applications and 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 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.
  • Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions.
  • 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.
  • Attend, present at, and lead meetings with FDA and other regulatory bodies.
  • Contribute to 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.

Requirements

  • Bachelor’s Degree in related field or an equivalent combination of education and work experience.
  • Minimum 8 years of related work experience with a complete understanding of specified functional area.
  • Comprehensive knowledge of a particular technological field.
  • Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
  • Is recognized as an expert in work group and across functions.
  • Will perform this job in a quality system environment.
  • Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Has broad knowledge of various technical alternatives and their potential impact on the business.
  • Experience in the medical device industry, preferred.
  • Experience with clinical trials, highly desirable.
  • Experience in a vascular/cardiovascular fields, a plus.
Benefits
  • Career development with an international company where you can grow the career of which you dream.
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial designscientific analysisregulatory submissionsstatistical analysisclinical study protocolscase report formsclinical study reportsinformed consent formspublication strategydata synthesis
Soft Skills
scientific leadershipmentoringcollaborationcritical analysiscommunicationproblem-solvingjudgmentprocess optimizationteamworkpresentation skills