Principal Clinical Scientist

2 days ago

Maple Grove MN United States Abbott Laboratories Full time

PRIMARY JOB FUNCTION

We have an exciting opportunity to join our rapidly growing clinical team within the Abbott Structural Heart division. The Principal Clinical Scientist will provide scientific expertise throughout the development and execution of clinical strategies (e.g. clinical trials, scientific publications) to support evidence generation for transcatheter mitral programs. He/she will design clinical trials from concept to execution by working collaboratively with biostatistics, medical affairs, regulatory affairs, global clinical operations, and other cross-functional team members. The individual will also take the lead in interacting with regulatory agencies, reimbursement agencies and clinical trial investigators to ensure successful execution of clinical strategies to meet corporate goals.

Core Job Responsibilities

This position will work closely within the clinical study team including the medical director, biostatistician, project management, data management, and other clinical study personnel. This position will have significant interaction with executive leadership, physicians and regulatory authorities. Furthermore, this position will be required to execute their job responsibilities within the corporate policies and standard operating procedures. This position will:

  • Design clinical trials and studies in collaboration with internal stake holders including clinical project management, clinical operations, clinical science, biostatistics data management, regulatory affairs, medical affairs as well as external stake holders including steering committees, and national principal investigators (if applicable).
  • Lead the generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study protocols, case report forms, clinical study reports, and informed consent forms
  • 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 publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
  • Support in development of clinical evidence generation plans
  • 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
  • Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area
  • Review and critically analyze statistical analysis plans
  • Lead study level (and franchise level where applicable) publication planning
  • Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions
  • Contribute to the optimization of internal processes and workflows
  • Develop new ideas for both external and internal projects
  • Attend, present at, and leads meetings with FDA
  • Mentor junior team members
  • Performs other related duties and responsibilities, on occasion, as assigned

Minimum Education

  • Bachelor's degree required, advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred.
  • Minimum of 8+years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience

Minimum Experience / Training Required

  • 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 cardiovascular or imaging fields a plus.
  • Travel

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