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Principal Clinical Scientist

2 months ago

Abbott Park, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories is a leading global healthcare company that develops and manufactures innovative medical products and solutions. Our mission is to help people live more fully at all stages of life.

Job Summary

We are seeking a highly skilled Principal Clinical Scientist to join our team. As a key member of our clinical research team, you will be responsible for developing and executing clinical strategies, managing clinical trials, and ensuring regulatory compliance.

Key Responsibilities
  • Develop Clinical Strategies

Develop, write, or mentor others in creation of clinical strategy, risk management, or clinical evaluation planning for products and process changes, to gain regulatory approval for product release, additional claims or indications, by addressing issues from a clinical, medical, and scientific perspective and by interacting with appropriate personnel.

Manage Clinical Trials

Develop, write, or mentor others in generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study reports, clinical study protocols, case report forms, investigational brochures, and informed consent forms.

Design Clinical Trials

Design or mentor others in the design of 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 and publication committees.

Develop Publication Strategy

Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy through coordination with investigator authors and internal teams.

Provide Scientific Support

Serve as an active member of 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.

Review and Analyze Data

Review and critically analyze statistical analysis plans.

Support Regulatory Submissions

Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions.

Requirements
  • Advanced Degree

Advanced degree in the sciences, medicine, or similar discipline.

Work Experience

8+ years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience.

Scientific Writing

Demonstrated scientific writing ability.

Quality System Environment

Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Independent Decision Making

Independent decision making required.

Complex Problem Solving

Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

Technical Knowledge

Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Broad Knowledge

Has broad knowledge of various technical alternatives and their potential impact on the business.

Preferred Qualifications
  • PhD Degree

PhD degree in the sciences, medicine, or similar discipline preferred.

Regulated Clinical Studies

Experience working on regulated, pre-market clinical studies preferred.

Quality System Environment

Experience working in a quality system environment preferred.

Medical Device Clinical Trials

Experience conducting medical device clinical trials preferred (TAVR in particular).

Investigational Device Exemption

Investigational Device Exemption (IDE) trial experience.

Physician Management

Physician management.

Safety Management

Safety management desirable.

External Clinical Research Committees

Experience working with external clinical research committees (i.e. screening committees, DSMB, CEC).