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Lilly Director, Clinical Data Systems, Data Flow and Innovation in Indianapolis, Indiana

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Director, Clinical Data Systems, Data Flow and Innovation has leadership accountability for clinical data collection, management and information capabilities and ownership of related technologies. The Director is responsible for developing the strategy for the requisite area, including the process automation and in contributing to the overall integrated automation strategy and portfolio capabilities across clinicals, to achieve cost efficient, aggressive timelines and improvement outcomes. This role is responsible for collaborating with Process Owners, CDDA and portfolio leadership in the development of information management strategies and plans, and working with IT leadership and Third Party Organizations (TPO) to drive plan implementation.

Primary Responsibilities:

  1. Develop, implement, and maintain the strategy for their area of focus while contributing to the integrated end-to-end clinical information automation strategy. Enable greater focus on integration of technology capabilities and priorities, including improved value identification, cost, and life-cycle management. Balance key strategic needs with funding capacity in developing trade-off options that optimize integrated (vs individual functional) solutions for the clinical portfolio. Collaborate with IT, DSS/CLO, Biometrics, and other CDDA leadership to drive continuous improvement in technology and process solutions that enable integrated data and analytics capabilities to drive end-to-end design and execution quality and efficiency gains. Partner with IT and leaders across the CDDA and, as needed, the MDU to determine project implementation plans and drive execution of agreed upon plans to ensure on-time delivery, management of project costs, are return on investment. Partner with IT to identify TPO strategies that will enable the CDDA's clinical systems strategy. Set clear business requirements and expectations to enable identification of appropriate technology solutions by the IT organization.

  2. Clinical Information Capability: Partner with business area leadership, enable and optimize capabilities for rapid clinical development modeling, managing investigator site information/services, and increased workflow automation. Develop capabilities and processes that enable timely, seamless information delivery to enable, high quality decisions, clinical program deliverables (submissions, responses to questions, publications, etc.), and that meet phase-specific information management expectations. Enable comprehensive clinical trial management and monitoring strategies inclusive of clinical trial metadata, study monitoring / metrics, risk & issue management and analytics.

  3. People Management and Development: Recruit, develop, and retain a scientific and operationally capable workforce skilled in clinical information management, knowledgeable in clinical development processes, and knowledgeable in the application of technology in clinical development. Build an organizational culture that fosters inclusion and innovation. Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio. Develop an organizational talent base that demonstrates judgment based decision making, and provides leadership across clinical development in optimizing clinical information management and process automation.

Minimum Qualification Requirements:

  • Bachelor’s degree and 10 years of experience in clinical drug development 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

Other Information/Additional Preferences:

  • Advanced degree (e.g. MSc, PhD) in a scientific or health care field

  • Proven ability to develop and deliver both strategic and tactical plans

  • Knowledge of emerging IT capabilities for medical research

  • A deep understanding of quality systems and process management

  • Proven ability to develop diverse organizational talent with next level potential

  • Strong interpersonal and excellent communication

  • Experience leading multi-disciplinary teams

  • Demonstrated problem solving ability and attention to detail

  • Passionate about improving technological solutions using new and emerging technologies

  • Ability to balance multiple activities, prioritize and manage ambiguity

  • Experience in, and/or leading different groups in drug development

  • Demonstrated ability to set and implement strategies and plans to improve complex drug development processes through process and technology optimization

  • Demonstrated ability to effectively partner/influence cross functionally to deliver results

  • Domestic and international travel required (10% - 15%), required

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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