AbbVie

Director Research Operations, US Medical Affairs

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 03, 2020
Ref
2005797
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Description:

The Director, US Research Operations, Medical Affairs provides operational leadership for Medical Affairs research activities for an assigned therapeutic area, this includes all AbbVie Medical Affairs studies, Investigator Initiated Studies, partnered alliance research and collaborative research. Leadership entails: oversight of the Annual Research Plan consistent with the wider evidence generation strategy, ensuring appropriate funding for such plan, operational and fiscal oversight of the plan with efficient and timely implementation, and adherence to compliance considerations wherever relevant. The position may lead personnel and the team responsible for the management of Medical Affairs research activities and is responsible for the complex cross functional integration necessary for a successful program.

Key Responsibilities include:

  • Partners closely with the TA Leads and key stakeholders in the development of the therapeutic area's overall Annual Research Plan including AbbVie Medical Affairs studies, RWD/RWE research, Investigator Initiated Studies (IIS), collaborative research and contracted research with academic institutions as the research operational contributor and subject expert.
  • Drives Contract Research Organization (CRO) selection process and provides direct management oversight for all contract research activities for study execution deliverables including financials.
  • Works with TA leadership/cross-functional Evidence Teams in the evaluation of research opportunities on an individual basis and aligns recommendations with Medical Affairs strategic initiatives to provide operational input on trial design, feasibility, financials and study execution.
  • Accountable to drive and deliver the operational execution activities related to external evidence generation activities and supervise internal personnel involved in the execution of these activities.
  • Identifies non-performing studies to return to TA Leadership/cross-functional US Medical Affairs Teams for discussion, risk mitigation.
  • Ensure a comprehensive and current view of all evidence generation activities for the assigned TA. Accountable for ensuring all ongoing research activities are being maintained within AbbVie systems and Medica Affairs process, procedures.
  • Propose, supervise and manage budgets for assigned Medical Affairs research plans.
  • Ensure compliance with internal SOPs and GCPs, working across functional areas for all approvals on contracts, protocols, and study documents as necessary.
  • Acts as study manager for USMA operationalized studies and conducts studies in accordance with relevant compliance regulations.
  • Provide oversight and mentorship for Staff and mentorship for other junior employees within Medical Affairs.
  • Serves as a cross functional link with Clinical Operations and Medical Affairs by participating in operational design on existing or developing Medical Affairs trials and participates on cross-functional data generation related transformation initiatives.
  • Serves as Operational Lead/facilitator of research governance teams such as the Global Evidence Team (GET), Research Review Committees, Alliance Partnerships and a contributing member of Integrated Evidence Strategy Teams (IESTs), Exploratory Data Teams (EDATs), and others as needed.
  • Accountable to drive and deliver Research Operations strategic initiatives to support the advancement of USMA research activities and projects. Works cross functionally with members of the US Medical Affairs Operations (USMO) Team to deliver assigned initiatives and transformation research activities.


Qualifications

Qualifications:

  • Bachelor's degree or equivalent is required, typically in a scientific field or nursing.
  • Advanced degree is desirable.
  • Must have 8+ years of direct clinical research experience and 6+ years of clinical research management.
  • Global program level clinical operational experience in interventional and non-interventional late phase research required
  • Management experience in other pharmaceutical positions desirable.
  • Pharmaceutical and CRO experience for the management of clinical trials desirable
  • Strong leadership skills with a good mix of strategic and tactical abilities and able to shift between both as needed.
  • Success working cross functionally in a matrixed environment with the ability to foster teamwork.
  • Excellent communication skills, both oral and written, with internal and external stakeholders


Significant Work Activities
Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.