TA Director, Clinical Data Strategy and Operations

Role Summary

TA Director, Clinical Data Strategy and Operations responsible for leading a global CDSO workforce to support assigned therapeutic areas within AbbVie’s clinical trial portfolio, executing through the designed operating model, and collaborating with R&D and regulatory functions to drive high-quality clinical data delivery.

Responsibilities

• Accountable for the execution via the CDSO operating model and for preservation of its integrity. Accomplishes this through maintaining standardization, leveraging designed economies of scale and scope, and harmonizing with a focus on clinical development efficiency and effectiveness ahead of function-specific optimization.
• Develops and empowers a leadership team that brings operations and domain expertise, unique perspectives, ability to inspire and influence, eagerness to co-create, and an engrained sense of ownership and accountability for successful execution.
• Ensures the standard for talent used to drive CDSO talent acquisition and development, and to differentiate the operations workforce is adhered to and perpetuated. The outcome is a team of operations and domain experts, future leaders, and industry influencers ‚Äì all with execution as their primary focus.
• Develops a culture that inspires personnel to question norms, to be intrapreneurial, to debate, and to take pride in execution and in facilitating others to execute. In conjunction, promotes and delivers balance between work and life to the workforce.
• Speed and quality are paramount. Uses the CDSO operating model in a manner that achieves flexibility and agility in maintaining both speed and quality in a sometimes-volatile environment.
• Provides oversight and fluid management of global operations resource allocation that spans employees, contractors, and functional service provider resources who support the assigned therapeutic area(s). Navigates drivers such as prioritization, long-term forecasts, immediate and sometimes episodic influences, normal demand fluctuation, and individual talent variation to achieve optimal outcomes.
• Participates in and contributes to industry consortiums as a critical AbbVie representative.
• Executes strategic road maps along with CDSO peers and peers from R&D functions. Supports validation of proposed strategy through alignment with leadership.
• Accountable for representing AbbVie with regulatory authorities to support inspections and queries.

Qualifications

• Bachelor‚Äôs degree required. Advanced degrees (e.g. MBA, PhD) preferred
• 10+ years of experience in pharmaceutical, biotech, or as an operations leader in an applicable industry, and 5+ years of matrix team management
• Broad business orientation, including advanced operations philosophy and methodology
• Crisp and clear communication in both written and oral forms
• Ability to approach situations with a neutral mindset, to gather evidence, to understand opposing points of view, and to form opinions that lead to results.
• Ability to model and manage performance behaviors, and teach those behaviors by example
• Creative and analytical thinker; ability to both generate novel ideas and to comfortably use data to make decisions.
• Demonstrated ability to effectively network, to influence at multiple levels and across multiple functions, to build strong relationships through demonstrated diplomacy and domain expertise when working cross-functionally
• Ability to work across functional and geographical boundaries to deliver results
• Ability to inspire our global workforce toward a singular purpose ‚Äì delivery of clinical data of the highest quality