Principal Clinical Research Scientist

Job Title

Principal Clinical Research Scientist

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Santa Clara, CA or Temecula, CA location in the Vascular division.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

The Principal Clinical Scientist provides scientific expertise throughout the development and implementation of clinical studies. Writes/manages clinical trial protocols, protocol amendments, clinical study reports, clinical trial registrations and results postings, clinical study project timelines (in collaboration with project manager) and scientific publications. Interacts with various study support cross-functional teams to assist in clinical strategy, the development of plans, reports and project deliverables. Interacts with regulatory agencies as needed and will use their scientific and medical knowledge to provide strategic communication to staff as well as study sites as directed by your manager.

What You’ll Work On

• Facilitates development of clinical strategy and trial design by interacting with key opinion leaders (KOLs) and collaborating cross functionally with other departments including Global Clinical Operations, Research & Development (R&D), Regulatory Affairs, Safety and Biostatistics.
• Writes study protocols, protocol amendments, informed consent forms, clinical study reports, prepare scientific presentations and writes manuscripts for publication in collaboration with KOLs by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
• Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings.
• Works collaboratively with R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Marketing and Sales, Senior Management and investigational sites.
• Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff.
• Creates, manages, or participates in clinical study timelines, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines.
• Throughout study, when appropriate, works cross functionally with clinical field teams and data management to assesses missing data. Uses metrics regularly to ensure data completeness. Works with Biostatistics to conduct ad-hoc/interim analyses for data surveillance.
• May work closely with external groups, such as core laboratories, to assess and interpret data.
• Writes responses to clinical questions from regulatory authorities. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
• Participates in and supports audits.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required Experience

• Bachelor’s degree in related field
• Minimum 8 years' experience
• Experience in clinical trials, working in a regulated environment.
• Experience in medical and scientific writing. Comprehensive knowledge of a particular technological field.

Preferred Experience

• PhD or MD preferred, or BA/BS with an equivalent combination of education and work experience.
• Familiarity with one or more data analysis software (such as Excel, Tableau, Power BI) is highly desirable.

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 Twitter @AbbottNews and @AbbottGlobal.