AbbVie

Director, Research Operations, US Medical Affairs

Employer
AbbVie
Location
Lake County, Illinois
Posted
Nov 19, 2021
Ref
2120180
Hotbed
BioMidwest
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.

The Director Research Operations oversees a research organization that works across all on-market/near to market products and is accountable for a broad range of evidence generation activities directly contributing to the operational delivery and execution of US Medical Affairs (USMA)-AbbVie sponsored studies, IIS, external clinical collaborative studies, exploratory data analysis, external collaborative registry/consortium, registry/database design sponsorship, database analysis sponsorship or grant and data set/analysis purchase. This role is responsible to build and maintain a high performing evidence generation team ensuring alignment of individual goals with therapeutic area and USMA goals.

Responsibilities:

  • Accountable for providing strategic direction and oversight of evidence generation execution. Requires working in partnership with Sr Directors /VPs across multiple functions across company (USMA, GMA, Development Operations, HEOR HQ, Legal, Outsourcing, Quality, OEC)
  • Build, maintain, optimize capabilities and roles needed to execute future state vision.  Ensure team resourcing in place to meet evolving business needs. 
  • Sets priorities and direction to meet needs of USMA Leadership evidence generation needs; leverage business acumen to understand organizational needs and anticipate evolving landscape.
  • Facilitates USMA risk planning and mitigation strategy for overall research execution in partnership with clinical operations study leads
  • Oversees a dynamic organization and is accountable for a broad range of activities directly contributing to the delivery of evidence generation activities across USMA, compliance with federal regulations and driving continuous improvement around execution of evidence generation activities
  • Ensures agile and thoughtful governance supporting all stages of research planning and execution. Drive leadership evidence oversight from weekly pre-screenings to monthly Scientific Review Committee Meetings. Partners effectively with Finance and Project Planners to provide timely and accurate financial forecasting and overall study budget management. 
  • Maintain an up to date knowledge of current industry practices and future trends as well as federal regulations and regulations governing all evidence generation activities
  • Responsible for people growth and development within own organization
  • Ensure appropriate staffing, systems and mechanisms to monitor and enable appropriate quality and oversight to evidence generation activities. Works closely with GMA Evidence Solutions partners to ensure USMA representation in and advancement from key evidence generation initiatives.

Qualifications

•A minimum of 15 years of practical experience in the Pharma Industry including experience in clinical program development in multiple therapeutic areas or leading major Clinical related Functions and a diversity of experience across the scope of Clinical Operations activities

•Bachelors Degree or higher in a life science discipline.

•Broad knowledge of Medical Affairs and drug development

•Demonstrate high level of competency in the AbbVie leadership behaviors

•Big picture and strategic thinker – can formulate a vision of future state and lead the organization to build tactical plans to achieve this.

•Excellent collaborator – easily builds relationships and gains cross functional alignment.

•Excellent business and financial aptitude, very analytical and uses data to drive the business and continuous improvements

•Strong communicator with Executive Presence with experience messaging to cross-functional and senior leaders and stakeholders

Key Stakeholders:

Reports to Senior Director, US Medical Operations.  Primarily interacts with USMA Head/VP, TA VP’s, TA Heads and GMO Evidence Leadership. Cross functional interfaces includes Development Operations, Data Sciences, GMA and R&D Finance including Project Management & Planning.


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % 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.