Medical Director, Clinical Research

7 days ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time

Abbott Laboratories is a leading healthcare company that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with top businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

We have an exciting opportunity to join our rapidly growing clinical team within the Abbott Structural Heart division. The Medical Director, Clinical Research 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.

The successful candidate 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. He/she 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.

Job Responsibilities
  • Design clinical trials and studies in collaboration with internal stakeholders including clinical project management, clinical operations, clinical science, biostatistics, data management, regulatory affairs, and medical affairs as well as external stakeholders including steering committees, and national principal investigators.
  • 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 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.
Requirements
  • 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.
  • 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.

$115,000 - $220,000 per year

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