Clinical Data Strategy and Operations (CDSO) is an industry-leading data management team that leverages top talent, lean processes, and state of the art technology to deliver high-quality, fit-for-purpose clinical data. The Director, Clinical Data Management Operations, is a leader of a global workforce that is accountable for supporting assigned therapeutic areas within AbbVie’s clinical trial portfolio. The Director is accountable for contributing to and supporting the design, development, and maintenance of the operating model. This accountability includes execution of talent acquisition and performance management, process development and evolution, quality control, continuous improvement, and change management.
The Director works with their CDSO peers who lead the technology team to ensure seamless integration of operations and technology, always striving together for flawless execution. The Director is a highly empowered leader, a decision-maker and influencer, and accountable to execute clinical development’s grand strategy. Above all, the Director develops relationships and collaborates with clinical development peers in a way that promotes a holistic and harmonized clinical trial delivery model.
Responsibilities
- Accountable for contributing to the design and development of the CDSO operating model and 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 – 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 assigned therapeutic areas. Navigates drivers such as prioritization, long-term forecasts, immediate and sometimes episodic influences, normal demand fluctuation, and individual talent variation to achieve optimal outcomes.
- Maintains clear line of sight to competitor activity, analyzing both industry and cross-industry operational advancements and leverages appropriately. Participates in and contributes to industry consortiums as a critical AbbVie representative.
- Contributes to strategic road maps along with CDSO peers and peers from R&D functions. Supports validation of proposed strategy through alignment with leadership. Will serve as a sponsor to shepherd strategy to execution.
- Accountable for representing AbbVie with regulatory authorities and contributing to policy discussions.