Sr Principal Clinical Scientist

3 weeks ago

St Paul, United States Abbott Laboratories Full time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Senior Principal Clinical Scientist

Working at Abbott 

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. Youâll also have access to: 

·         Career development with an international company where you can grow the career you dream of. 

·         Free medical coverage for employees* via the Health Investment Plan (HIP) PPO 

·         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 bachelorâs 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.  

 

The Opportunity  

This position works out of our St. Paul, MN location, supporting transfemoral transcatheter mitral valve replacement (TF TMVR). The Senior Principal Clinical Scientist will lead scientific activities associated with the design, conduct, and reporting of clinical trials for this therapeutic area. 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. 

 

What Youâll Work On: 

This position will work closely with the clinical study team including project management, biostatistics, data management, and other clinical study personnel. This position will have significant interaction with leadership and regulatory authorities. Furthermore, this position will require you to execute job responsibilities within the corporate policies and standard operating procedures. Additionally: 

 

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

·â¯â¯â¯â¯â¯â¯ Develops, writes, or mentors others in generation of study-related documents and/or contributes 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. 

·â¯â¯â¯â¯â¯â¯ Designs or mentor's others in the design of clinical trials and studies in collaboration with internal stake holders including clinical project management, clinical operations, biostatistics data management, regulatory affairs, medical affairs, and external stake holders including steering committees, study leadership and publication committees. 

·â¯â¯â¯â¯â¯â¯ Develops 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. 

·â¯â¯â¯â¯â¯â¯ 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. 

·â¯â¯â¯â¯â¯â¯ Review and critically analyze statistical analysis plans. 

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

 

Required Qualifications:â¯Â 

·â¯â¯â¯â¯â¯â¯ Advanced degree in the sciences, medicine, or similar discipline. 

·â¯â¯â¯â¯â¯â¯ 10+ years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience.â¯â¯Â 

·â¯â¯â¯â¯â¯â¯ Demonstrated scientific writing ability. 

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

·â¯â¯â¯â¯â¯â¯ Independent decision making required. 

·â¯â¯â¯â¯â¯â¯ Works on complex problems where analysis of situations or data requires an in-depth evaluation of numerous factors. 

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

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

·â¯â¯â¯â¯â¯â¯ Experience working on regulated, pre-market clinical studies. 

·â¯â¯â¯â¯â¯â¯ Experience working in a quality system environment. 

 

Preferred Qualifications: 

·â¯â¯â¯â¯â¯â¯ Experience conducting mitral valve replacement (TS TMVR in particular) trials preferred. 

·â¯â¯â¯â¯â¯â¯ Early Feasibility Study (EFS) experience preferred. 

·â¯â¯Â Â Â Â  Pre-market approval (PMA) application experience preferred. 

·â¯â¯â¯â¯â¯â¯ Experience evaluating and contracting CROs, scientific core labs, and establishing and managing trial Steering Committees preferred. 

·â¯â¯â¯â¯â¯â¯ Experience overseeing and conducting Medical Advisory Board (MAB) meetings preferred. 

 

 

Apply Now 

  

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. 

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on X @AbbottNews. 



The base pay for this position is $109,300.00 â $218,700.00. In specific locations, the pay range may vary from the range posted.

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