Director, Clinical Data Strategy & Operations, Immunology

Irvine, California
Nov 03, 2021
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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose: The Director, Clinical Data Strategy & Operations (CDSO) is a senior leader reporting to the Sr. Director, CDSO. At the highest level, the Director is accountable for ensuring the timely delivery of clinical databases that meet the highest standards of quality and compliance for all AbbVie clinical trials within the assigned therapeutic area(s). This position may have remote possibilities. 
• Brings people, processes, and technologies together to generate highest data in support of Pharmaceutical Development’s objectives.
• May manage multiple therapeutic areas.
• Directly manages a team of Directors and/or Associate Directors.
• Accountable for the agile development of clinical trials databases and data capture systems, for the integrity of collected data, and for the overall continuity of clinical data processes for AbbVie clinical development
• Ensures that technology and standardized processes are established and executed, globally.
• Manages a large resource pool including employees, contingent workers, CROs, and functional service providers. Accountable for resource acquisition, utilization, and associated budget management tied to assigned therapeutic area(s).
• Has advanced knowledge of clinical technologies and can contribute to both strategic and tactical planning.
• Co-develops sustainable and scalable strategy, including multi-year strategy, for CDSO and partners cross-functionally to develop pharmaceutical development-wide strategy.
• Sponsors cross-functional process and technology initiatives.
• Accountable to guarantee operations meet good clinical practice through establishment of controls, measures, and through development of a quality-conscious culture
• Builds strong, lasting relationships with CDSO leaders and staff, and with cross-functional leaders.
• Cultivates future leaders of both CDSO and other functions through talent management processes

  • BS/MS in computer science, information systems management, health informatics, engineering, life sciences, business, or related fields.
  • 15+ years in life science industry
  • 8+ years supervisory experience
  • Expert knowledge of clinical data operations, clinical data management systems, operations systems, both clinical and operational analytics, and supported processes
  • Expert knowledge of decision support methodologies and technologies
  • Understanding of emerging requirements, regulations, and technologies and the possible impact to R&D
  • Strong leadership, problem solving, interpersonal and communication skills required for development and advancement of strategies critical to execute the Pharmaceutical Development portfolio requirements
  • Ability to effectively collaborate/network, to influence multiple levels across multiple functions, build strong relationships, and to negotiate with diplomacy
  • Ability to work across functions and across geographic boundaries to develop project strategies

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 20 % of the Time
Job Type
Job Level Code
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.