Reporting to the U.S. Senior Director of Research Operations, this role provides operational leadership and governance for U.S. Medical Affairs (USMA) supported studies, including internally and externally sponsored studies and serves as the Data Catalyst for USMA. This individual manages the templates, tools, and associated training to enable team consistency and execution across the Portfolio. This individual is also responsible to drive and implement effective system improvements, applying change management principles, and serve as Business Process Owner for SPIRIT, TESLA, and any other operating systems. This individual will also deliver Portfolio and execution oversight, as well as management and reporting of Key Performance Indicators.

Responsibilities

• As the data catalyst, responsible to develop associated processes, tools, and training to drive the use of data convergence methods in medical affairs research. The data catalyst will represent USMA at Data Convergence cross-functional meetings and provide updates to these forums and communicate key information back to USMA.
• Manages oversight, forecasting and reporting of research operations portfolio of work including performance reporting and financial management.
• Design and roll-out of key business management processes, standards and governance related to planning and execution of studies designed to collect real world evidence (particularly, non-interventional studies (NIS), Investigator Initiated Studies [IIS], and Collaborations [Collabs] to ensure connectivity of strategic outputs to business plan tactical implementation across USMA.
• USMA Business System Owner for clinical trial management system (CTMS), responsibilities include but are not limited to, drive continuous improvement and maintenance of CTMS (development of roadmap) from the business perspective, development and roll-out (and maintenance) of training materials, management, and reporting of Key Performance Indicators (KPIs).
• Working across USMA stakeholders (i.e., Therapeutic Area, Research Operations), responsible for the process and facilitation of the strategic planning for NIS.
• Oversees the operational management of IIS and Collabs from start-up through closeout to ensure compliance with company and industry requirements, agency regulations and guidelines, responsible for delivery of the IIS Strategic Priorities.
• Serves as owner of U.S. Medical Affairs portfolio materials (i.e., templates, training materials), ensuring appropriate access and use by all stakeholders; leads communications and change management related to study management tools and processes.
• Facilitates centralized governance for U.S. Research Operations (USRO) and other related initiatives, to include but not limited to: identification of projects, process for review and reporting, timelines, record of KPIs, etc.
• Serves as USMA Lead for the Pre-approval Access Program (PAA) to ensure organizational excellence, compliance, and strategic guidance
• Support Senior Director of Research Operations on functional budget forecasting and management.
• USRO contact for training plans, audits/inspections, and updates to Standard Operating Procedures.

• Bachelor’s degree or international equivalent is required; degree in a health-related, scientific, or engineering field preferred. Advanced degree is desirable.
• At least 10 years of work experience in the pharmaceutical industry or related professional experience including supervisory / leadership and clinical research. Experience in management of clinical trials is desired.
• Demonstrates strong leadership competencies with broad business orientation (strategic and tactical abilities), functions as a role model and driver of AbbVie leadership attributes.
• Proven communication, organizational and project management skills with the ability to lead a team and/or project in a global matrix environment.
• Proven record of building effective working relationships across functions

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.