Sr. Director -Trial Management Systems, Clinical Trial Foundations

Role Summary

Sr Director, Clinical Trial Foundations (CTF) focuses on capabilities related to data capture; data delivery; site platforms, monitoring and eTMF; help desk; external focus; management of pilots, Transcelerate; and Business Process Management and OCM/Coms. The Sr Director is a cross-functional leader and key partner across the business and Tech@Lilly for clinical information management capabilities, serving as the clinical system owner and responsible for the development, implementation and maintenance of the clinical information management and process automation strategy for their area of focus, while contributing to the integrated end-to-end clinical information automation strategy. They actively engage with internal and external partners on new operating models, capabilities and technologies, and collaborate with Process Owners and CDDA leadership in the development of information management strategies and plans, working with Tech@Lilly leadership and Third Party Organizations (TPO) to drive plan implementation.

Responsibilities

• System and Capability Ownership and Data Flow
  • Gain and maintain strategic alignment for clinical systems with the needs of all user communities and related initiatives.
  • Define and manage clinical system and/or capability implementation and scale-up strategy and plan.
  • Drive development, use, and quality of clinical systems.
  • Serve as clinical system(s) owner.
  • Develop, implement, and maintain the clinical information management and process automation strategy for their area of focus while contributing to the integrated end-to-end clinical information automation strategy with business and Tech@Lilly partners.
  • Accountable for fiscal responsibility of vendors associated with CTF.
  • Actively engages with internal and external business partners to evaluate attributes and risk associated with new operating models, capabilities, and technologies.
  • Accountable for the delivery and sustainability of projects in CTF.
  • Development and implement integrated communication plans across the organization.
  • Maintain visibility across interdependencies across projects.
  • Foster collaboration amongst stakeholders and facilitate efficient decision-making.
• Enterprise Leadership and External Focus
  • Continually seek and implement improvements to reduce cycle time and decrease work effort resulting in decreased costs that optimize clinical information flow, process and technology.
  • In partnership with Tech@Lilly leadership and the business, identify TPO strategies that will enable the CDDA’s clinical information and automation strategy. Provide leadership in the setting of clear business requirements and expectations to enable identification of appropriate technology solutions by the Tech@Lilly organization.
  • Lead cross-functional initiatives.
  • Within functional and cross-functional teams, exhibit strong business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs.
  • Represent the CTF organization at appropriate internal and external venues.
  • Drive shared learning and process expertise between teams within the organization.
• People Management and Partnership
  • If applicable, recruit, develop, and retain a scientific, technical and operationally capable workforce skilled and knowledgeable in the overall CTF organization.
  • Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio.
  • Build an organizational culture that fosters inclusion, innovation, and promotes diversity.
  • Partner closely with CDDA leadership, Tech@Lilly and other functions to effectively plan, forecast, and manage the sanctioned projects.

Qualifications

• Required: Bachelor’s degree and 5 years of experience in clinical drug development or information flow with expertise in related process, technology and information flows (clinical results and operational) such as IT, Data Sciences, Statistics, Clinical Development, Clinical Project Management and/or Quality/Regulatory.
• Required: Demonstrated ability to set and implement strategies and plans to improve complex drug development processes and capabilities.
• Required: Strong networking, interpersonal and relationship skills, with demonstrated ability to work in teams, across organizational boundaries and achieve results through others.
• Required: Demonstrated credibility and ability to influence peers, management and senior leadership.
• Required: Indianapolis based position.
• Preferred: Previous supervisory experience.
• Preferred: Previous experience with system ownership, implementation of new technology, business process automation.
• Preferred: Proven ability to develop and deliver both strategic and tactical plans.
• Preferred: Knowledge of emerging IT capabilities for clinical research.
• Preferred: Strong problem solving skills.
• Preferred: Flexibility to adjust quickly to changing business priorities.