Senior Director, Clinical Program

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

This leadership position will manage Clinical Research professionals encompassing Clinical Affairs, Clinical Science, Clinical Biometrics (Statistics), Clinical Safety, Clinical Quality, and/or Clinical Project Management. This position is responsible for the conduct of Clinical Research and the preparation of product submissions for U.S. and non-U.S. regulatory agencies through the Clinical Research Organization. This individual assures the long-term effectiveness of the organization and ensures that the needs of the division with respect to Clinical Research are met. The position establishes long range plans and goals/functions and is responsible for the implementation and maintenance of the clinical research-related policies, processes and procedures related to their respective functional areas.

What You’ll Work On

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Provides significant and meaningful Clinical support to business unit leaders.
• Work and interact with key clinician’s external to the organization – represent the division and Clinical Research in a positive manner to external contacts/KOLs.
• Develops internal teams, provides leadership and guidance to the larger Clinical organization; mentors, coaches, develops their employees worldwide.
• Provides strategic guidance to Quality.
• Manages cross-functional teams within the Clinical Research organization.
• Direct the design, planning, development and monitoring of all clinical evaluation projects or clinical studies as directed by your manager.
• Interact and lead scientific, clinical, and business activities at trial sites for the division.
• Direct team to ensure that clinical studies and/or clinical evaluations of those products determined to satisfy medical needs and/or commercial potential are conducted.
• Take the lead role in the development of the clinical planning and/or strategy. Define the clinical plan by establishing the appropriate clinical protocol for the desired product claim or indication.
• Establish and maintain appropriate systems to ensure adherence to ICH/GCP, risk management, and/or quality system guidelines including training and successful results from independent audits.
• Generate clinically/scientifically sound statistically analyzed data to confirm performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements.
• Review the clinical studies sections for regulatory submissions to ensure adequacy of support for all claims pertaining to safety, efficacy, clinical performance and Independent Review Board or ethics committees.