Abbott
Senior Clinical Scientist
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. This position can work out of our Santa Clara, CA, St. Paul, MN or Maple Grove, MN location, supporting transcatheter mitral repair therapies within the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Senior Clinical Scientist will support scientific activities associated with the design, conduct, and reporting of clinical trials for this therapeutic area. At Abbott we're advancing the treatment of heart disease through breakthrough, minimally-invasive medical technologies, restoring health and allowing people to get on with their lives. What You'll Work On: Supports senior clinical personnel in the development 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. Develops and writes, study-related documents and/or contributes content of such documents, including, but not limited to, clinical study reports, clinical study protocols, case report forms, investigational brochures, and informed consent forms. Will assist in the development of procedures and methods aimed at ensuring excellent patient clinical outcomes during the conduct of clinical studies. Supports senior clinical personnel 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, and external stakeholders including steering committees, study leadership and publication committees. Supports the development of the scientific podium and publication strategy in close collaboration with cross-functional teams and leads the execution of the publication strategy through coordination with investigator authors and internal teams. 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. Support the review and analysis of statistical analysis plans. Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions. Generate and review documents to support adherence to Medical Device Regulations (MDR) Required Qualifications: Advanced degree in the sciences, medicine, or similar discipline. 5+ years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience. Demonstrated scientific writing ability. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Independent decision making required. 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 working on regulated, pre-market clinical studies. Experience working in a quality system environment. Preferred Qualifications: Experience conducting clinical studies of implantable cardiac devices preferred. Experience managing trial Steering Committees and authoring scientific publications preferred. Experience with statistical analysis software such as SAS, R, MatLab, STATA, or similar preferred. Master's degree in the sciences, medicine, or similar discipline preferred. The base pay for this position is $85,300.00
$170,700.00. In specific locations, the pay range may vary from the range posted.
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. This position can work out of our Santa Clara, CA, St. Paul, MN or Maple Grove, MN location, supporting transcatheter mitral repair therapies within the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Senior Clinical Scientist will support scientific activities associated with the design, conduct, and reporting of clinical trials for this therapeutic area. At Abbott we're advancing the treatment of heart disease through breakthrough, minimally-invasive medical technologies, restoring health and allowing people to get on with their lives. What You'll Work On: Supports senior clinical personnel in the development 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. Develops and writes, study-related documents and/or contributes content of such documents, including, but not limited to, clinical study reports, clinical study protocols, case report forms, investigational brochures, and informed consent forms. Will assist in the development of procedures and methods aimed at ensuring excellent patient clinical outcomes during the conduct of clinical studies. Supports senior clinical personnel 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, and external stakeholders including steering committees, study leadership and publication committees. Supports the development of the scientific podium and publication strategy in close collaboration with cross-functional teams and leads the execution of the publication strategy through coordination with investigator authors and internal teams. 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. Support the review and analysis of statistical analysis plans. Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions. Generate and review documents to support adherence to Medical Device Regulations (MDR) Required Qualifications: Advanced degree in the sciences, medicine, or similar discipline. 5+ years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience. Demonstrated scientific writing ability. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Independent decision making required. 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 working on regulated, pre-market clinical studies. Experience working in a quality system environment. Preferred Qualifications: Experience conducting clinical studies of implantable cardiac devices preferred. Experience managing trial Steering Committees and authoring scientific publications preferred. Experience with statistical analysis software such as SAS, R, MatLab, STATA, or similar preferred. Master's degree in the sciences, medicine, or similar discipline preferred. The base pay for this position is $85,300.00
$170,700.00. In specific locations, the pay range may vary from the range posted.