Director, Global 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, Global Clinical Affairs

US based (local to an Abbott office)

DO WORK THAT MATTERS

Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. IDEM is $1B+ business unit that supports significate growth for Abbott in COVID-19 related products in over 70+ countries.

Responsible for Infectious Disease Emerging Markets, IDEM business unit Clinical Affairs function and related activities. Establishing policy and strategy for all IDEM BU Clinical Affairs activities, managers and staff. Responsible for insuring hiring, training and management of Clinical Affairs staff and managers. Key objectives of role: Develop a very complete and comprehensive strategy for division products, including ongoing clinical trials. Will be involved in assessment of technology focus, clinical trial design, sequencing of projects, justification of improvements, regulatory challenges, etc. Critical in determining how business maintains focus on clinically relevant, approvable, reimbursable products that result in a profitable business for the division. Assure enrollment in critical clinical studies, provide leadership in developing and/or modifying division clinical and training strategies based on an in depth assessments of existing/available clinical data. Monitor FDA and CMS perspectives on critical issues (i.e. standard risk patients) and adjust clinical strategies as relevant. Provide scientific and technical protocol input in new and emerging solution business technologies. Scope of role includes a significant quality component. Will conduct Health Hazard Assessments (HHA's) to assess medical risk for both products in development and on market.

  • Infectious Disease Emerging Markets, IDEM business unit Clinical Affairs function and related activities.
  • Establishing policy and strategy for all IDEM BU Clinical Affairs activities, managers and staff.
  • Ensuring hiring, training and management of Clinical Affairs staff and managers.


Key objectives:
  • Develop a very complete and comprehensive strategy for division products, including ongoing clinical trials.
  • Will be involved in the assessment of technology focus, clinical trial design, sequencing of projects, justification of improvements, regulatory challenges, etc.
  • Critical in determining how business maintains focus on clinically relevant, approvable, reimbursable products that result in a profitable business for the division.
  • Assure enrollment in critical clinical studies, provide leadership in developing and/or modifying division clinical and training strategies based on in-depth assessments of existing/available clinical data.
  • Monitor FDA and CMS perspectives on critical issues (i.e. standard-risk patients) and adjust clinical strategies as relevant.
  • Provide scientific and technical protocol input in new and emerging solution business technologies.
  • Scope of the role includes a significant quality component.
  • Will conduct Health Hazard Assessments (HHA's) to assess medical risk for both products in development and on market.


RESPONSIBILITIES
  • Develop Clinical Affairs strategy and advise senior management in Clinical Affairs strategic planning for purpose of long range planning for division.
  • Evaluate new technologies for potential acquisition or internal funding/development.
  • Develop regulatory and clinical pathways for early stage promising technologies.
  • Influence and work with clinical/regulatory staff to outline specifics of clinical trial design.
  • Influence and interact with FDA and international regulatory bodies in regulatory submission processes, response to inquiries, clinical study results, agency inquiries, etc.
  • Work with U.S. and OUS marketing staff to enhance product launches through effective utilization of clinical study results.
  • Design and deliver training for commercial organization to enhance and increase influence with customers, health care professionals and key opinion leaders.
  • Develop and enhance economic and cost-effectiveness models for reimbursement during the regulatory phase of device development.
  • Represent the division in interactions with health care professionals in symposiums, professional meetings, etc.
  • Design and continually improve effectiveness of commercial organization and clinical affairs organizations through development of disease detection programs, education of physicians, expanding therapeutic options.
  • Leverage division business with other Abbott business to enhance business growth opportunities for Abbott.
  • Hire, train, motivate and develop Clinical Affairs staff.
  • Prepare budgets and manage the clinical operations program within established budget and timelines by ensuring development of accurate study budgets; contract development and execution; and approving payments and tracking of study expenditure.
  • Direct the design; planning; development and monitoring of all clinical studies to ensure fulfillment of requirements for regulatory submissions.
  • Coordinate functional areas involved in clinical operations to solve problems; assure project progress and timely completion of project goals.
  • Direct Clinical Research Managers to ensure that clinical studies that meet user needs and regulatory requirements are conducted.
  • Manage clinical operations by developing; mentoring; and effectively delegating.
  • Effectively communicate; through the planning and execution of meetings and presentations; project goals; milestones; and updates; to senior management and other functional areas; and regulatory authorities.
  • Develop and implement training programs to ensure compliance with relevant FDA and international regulations and ensure adherence to ICH/GCP guidelines.
  • Monitor training effectiveness by assessing trends in audit observations and drive continuous improvement initiatives by developing new training activities; as appropriate.
  • Negotiate contracts with investigators; vendors; and CROs.
  • Provide compliance guidance on the conduct of clinical research division-wide; for developing and overseeing a quality training program and for compliance in all audits of the Clinical Research organization.
  • Represent the Division's clinical research programs at cross-functional meetings; FDA meetings; FDA
  • Advisory Committee meetings and in discussions with senior management and trade meetings.


QUALIFICATIONS
  • Bachelor's Degree is required
  • B.S. in biological or medical science preferred. Master's Degree or higher is desirable.
  • Preferred: Clinical Laboratory Certification MT(ASCP) or CRA (CCRA)
  • Knowledge of regulations and standards (GCP) affecting IVDs and Biologics required
  • Minimum of 12 years direct clinical research experience, of which a minimum of 3 years clinical research supervisory or management capacity with budgetary responsibility.


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