Director, Clinical Affairs

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 109,000 colleagues serve people in more than 160 countries.

Director, Clinical Affairs (Princeton, United States) - Abbott Point of Care (APOC)

Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry's most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.

Our Clinical Affairs Team has an opportunity for a Director, Clinical Affairs. As part of the Clinical Affairs leadership team, the Director, Clinical Affairs is responsible for developing clinical strategy, direction, planning and execution of clinical trials within the business portfolio for both new and existing products. The Director, Clinical Affairs will manage a team and will be accountable for achievement of both timeline performance and budget goals for overall area of responsibility within APOC.

WHAT YOU'LL DO

  • Responsible for developing clinical strategy, direction, planning and execution of clinical trials within the business portfolio.
  • Defines the clinical plan by establishing the appropriate clinical studies for the desired product claims and/or indications.
  • Gathers input from cross-functional teams, project stakeholders, and the clinical services team to create plans enabling the team to deliver successful product on schedule.
  • Directs team to ensure that clinical studies and/or clinical evaluations of those products satisfy medical needs and/or commercial potential.
  • Represents the Division's clinical research portfolio and results at Global Regulatory Agency meetings, Advisory or Panel Committee meetings and in discussions with senior management and trade meetings.
  • Manages team of Clinical Program Managers, Clinical Project Managers and CRA Managers and conducts ongoing review of team and project assignments to ensure adequate support to meet Divisional Clinical Research goals across multiple trials within the business portfolio.
  • Develops internal teams, provides leadership and guidance to the larger clinical organization; mentors, coaches, and actively develops their employees.
  • Manages cross-functional teams within the external Clinical Research organization as needed.
  • Works and interacts with key clinicians external to the organization - represent the division and Clinical Research in a positive manner to external contacts/KOLs.
  • Accountable for achievement of both performance and financial goals for overall area of responsibility.
  • Establishes 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.
  • Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets.
  • Ensures staff are trained on the requirements of the clinical project and the project plan.
  • Presents project plans, provides ongoing updates and presents project results to Division management.
  • Responsible for ensuring the clinical project is audit-ready at all times (e.g. project team training records, central files, system validation, etc.).
  • Evaluates clinical data in preparation of study summary reports for presentations, publications and regulatory submissions and ensures statistically analyzed data are clinically/scientifically sound to confirm performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements.
  • Provides oversight of clinical project to ensure safety concerns and/or adverse events or trends in Field Events Reporting.
  • Develops and implements corrective actions as needed to address any noncompliance issues.
  • Responsible for continuous improvement initiatives, leveraging new technology consistent with regulatory and compliance strategies, and assuring appropriate training and education programs are in place.
  • Identifies and adapts to shifting priorities and competing demands.
  • Remains current in the field of expertise including clinical and i-STAT product knowledge.
  • Maintains, promotes, and models ethical and organizational principles by adherence to applicable Corporate and Divisional Policies and Procedures.


EDUCATION AND EXPERIENCE YOU'LL BRING

Required
  • Minimum of 12 years clinical trials experience, of which at least 10 years' experience with clinical studies conducted per GCP with direct clinical site monitoring and/or clinical site management experience functioning in a lead capacity with supervisory or demonstrated leadership role.
  • Knowledge and experience in identifying and working with external CROs.
  • Experience in hiring, managing, and directing clinical managers and CRAs.
  • Experience in managing and directing team size up to 30-40 employees.
  • Knowledge and experience in designing clinical studies, understanding of statistical techniques, interpreting clinical studies results.
  • Understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory and compliance requirements of clinical research.
  • Experience running clinical trials in international geographies (preferred).
  • Influence and lead both with and without direct authority.
  • Ability to clearly, concisely and accurately communicate (written and oral)
  • Ability to confidently speak in public, lead meetings and group discussions
  • Form and develop long-term strategic and professional relationships; display socially and professionally appropriate behavior.
  • Ability to work independently and in groups
  • Skilled in relationship building and matrix management, demonstrating superior leadership and coaching skills.
  • Demonstrated leadership skills, initiative, critical-thinking and problem-solving skills.
  • Strong organization and time management skills.
  • Bachelor's Degree required. Advanced degree (Masters or PhD or MD) is preferred.
  • Certification from the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) preferred.
  • Medical Device/Diagnostics Clinical experience, understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage.
  • Experience managing other clinical operations positions.
  • Willing and able to travel up to 20% of the time to meet investigators and clinical trial staff.


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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