Principal Clinical Scientist
United States - California : Remote
JOB DESCRIPTION:
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. You’ll 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 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.
The Opportunity
This position works out of our SH division.
Structural Heart Business Mission: Why We Exist
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.
As the Principal Clinical Scientist, you'll have the chance to work closely with the clinical study team including project management, biostatistician, data management, and other clinical study personnel. This position will have significant interaction with leadership and regulatory authorities. Furthermore, this position will be required to execute their job responsibilities within the corporate policies and standard operating procedures.
What You’ll Work On
- 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, additional claims or indications, by addressing issues from a clinical, medical, and scientific perspective and by interacting with appropriate personnel.
- Develops, writes, or mentors 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.
- Designs or mentors 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 as well as external stake holders including steering and publication committees.
- 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.
- 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 critically analyze statistical analysis plans.
- Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions.
Required Qualifications
- Advanced degree in the sciences, medicine, or similar discipline.
- 8+ 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.
Preferred Qualifications
- PhD degree in the sciences, medicine, or similar discipline preferred.
- Experience working on regulated, pre-market clinical studies preferred.
- Experience working in a quality system environment preferred.
* 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
$95,000.00 – $190,000.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
SH Structural Heart
LOCATION:
United States > California : Remote
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 20 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Apply
Job Profile
Remote
Benefits/PerksCareer development Education benefit Education benefits Excellent retirement savings plan Freedom 2 Save student debt program Free medical coverage Free medical coverage for employees FreeU education benefit Great Place to Work Health and wellness benefits Recognized as a great place to work Retirement savings plan Student debt program Tuition reimbursement Wellness assessment Work that matters
Tasks- Collaborate with study teams
- Design clinical trials
- Develop clinical strategy
- Documentation
- Leadership
- Project management
- Support regulatory submissions
- Write clinical documents
Biostatistics Branded generic medicines Clinical Evaluation Clinical Strategy Clinical Studies Clinical Study Protocols Clinical Study Reports Clinical trials Collaboration Cross-functional Teams Data Management Diagnostics Documentation Education English Healthcare Leadership Management Medical Affairs Medical Devices Nutritionals Operating procedures Planning Project Management Quality System Quality System Environment Regulatory Affairs Regulatory Approval Regulatory Submissions Reimbursement Risk Management Scientific analysis Statistical analysis Structural Heart
EducationAdvanced degree Business DO Equivalent Healthcare Statistics
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9