Advisor, Clinical Research

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.

     

JOB DESCRIPTION:

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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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

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. Our location in Santa Clara, CA, currently has an opportunity for an "Advisor, Clinical Research" to join our ONSITE Clinical Science team

This position will work closely within the clinical study team including the medical director, biostatistician, project management, data management, and other clinical study personnel. This position will have significant interaction with executive leadership, physicians 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

• Design 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 committees, and national principal investigators to support device premarket approval (PMA) applications and premarket notification submissions (510(k)) to the FDA and strategic business needs. 

• Independently provides scientific leadership to Cross Functional and Commercial Teams to support business priorities and serve as Clinical Science lead

• Acts as lead scientist, project leader, or project contributor.  Provides scientific and technical direction and feedback. Scientific leader to drive business strategy. Anticipates business needs and implements strategies to address.

• Lead the generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study protocols, case report forms, clinical study reports, and informed consent forms

• Translates strategic needs of the division into executable programs and projects.  Works independently to meet goals and divisional objectives. 

• Critically analyze data and present to internal and external groups including but not limited to clinicians and cross-functional team members

• Develop the scientific podium and publication strategy in close collaboration with cross-functional teams, and lead the execution of the publication strategy

• Lead/collaborate on submission of abstracts, presentations, and publications of clinical study data working with investigator authors

• Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area

• 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

• Contribute to the optimization of inte