Principal Clinical Scientist
Principal Clinical Scientist
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$ 97300 - 194700
1 Vacancy
Job Description
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. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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 youll 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 Youll 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 in a scientific medical or related discipline.
Experience with regulated and post-market clinical studies.
Familiarity with quality system environments.
Strong background in medical device clinical trials.
Knowledge of MDR requirements and experience developing PMCF Plans/Reports.
Experience in physician and safety management.
Prior collaboration with external clinical research committees (e.g. screening committees DSMB CEC).
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews.
The base pay for this position is
$97300.00 $194700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
SH Structural Heart
LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.
ADDITIONAL LOCATIONS:
United States > Santa Clara : 4551 Great America Parkway
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Staff IC
Employment Type
Full-Time
Key Skills
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