Director, Clinical Data sciences

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 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.

Director, Clinical Data Sciences

Purpose:

The Director, Clinical Data Sciences, role is to define, staff and lead a Clinical Data Sciences function to provide administrative direction, leadership, process expertise and influence to members of the broader Clinical Data Sciences organization. The Director is primarily responsible for on-time and high quality deliverables, appropriate staffing, budget and resource management, asset protection, coaching and mentoring, staff development, performance management, project planning/management, knowledge sharing, regulatory compliance, strategy implementation and execution, and process improvements for a Business Unit and Therapeutic Area. The Director will be accountable for developing the data and analytics capabilities supporting implementation and execution of the end to end dataflow transformation from CRF design to output creation. The Director will also be responsible for providing technical expertise and guidance in support of key business initiatives (data clean automation, unified comprehensive data verification, tools development & implementation) critical to innovation and productivity. This leader will contribute to establishing a long-term competitive advantage with the Clinical Data Sciences function by recruiting and developing the top talent, evolving sourcing strategy and increasing the effectiveness and efficiency of Clinical Data Sciences. This leader will report to the Sr. director of the Clinical Data Sciences organization.

Responsibilities:

Portfolio Delivery

• Partner with Therapeutic Areas and the Business Units to provide proactive strategic and scientific input for clinical data planning and execution that enable effective and efficient delivery of high quality clinical outcomes with agreed upon metrics
• Partner with the Design Hub and asset teams to ensure clinical data strategies and plans are understood and effectively incorporated into clinical plans, protocols and plan documents
• Accountable for driving project decisions related to clinical data execution options, including integrated functional sourcing recommendations
• Ensure strong linkages exist between clinical design and execution.
• Partner closely with other development and administrative functions to effectively plan, forecast, and manage the resources required to deliver all sanctioned projects
• Drive efficiency and continuous improvement in the Clinical Data Sciences organization and, as appropriate, cross-functionally to support therapeutic area and Business Unit aligned deliverables
• Develop a portfolio transition plan from vendors to LCCI and implement flawlessly

End to End Dataflow Transformation

• Implement and execute the data & analytics strategy (process, technology needs, quality standards, automation, external partnerships) to achieve seamless dataflow
• Implement data & analytics capabilities strategy to realize data process transformation and automation of dataflow
• Drive key business initiatives (automation of data clean, etc) critical to productivity
• Implement a strategy for integrating and leveraging LCCI capabilities to drive transformation

Capabilities Development

• Stay current with respect to the rapidly changing business initiatives (automation of data clean and SDTM creation etc.) and emerging technology and system
• Stay current with novel software/tool and evolving technologies, including the development, adoption and implementation of tools and capabilities that support and accelerate our strategy
• Have broad understanding about business initiatives to assist in defining innovative data and analytics projects that may improve efficiency in our business
• Identify opportunities to standardize/automate processes to free time for more innovative work

Enterprise Leadership

• 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 Clinical Data Sciences organization at appropriate internal and external venues to demonstrate the leadership
• Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China
• Accountable for fiscal responsibility of clinical data and analytics plans and contracts
• Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations
• Drive continuous improvement of key performance metrics
• Model and champion Team Lilly approach enabling  shared learning and process expertise between teams within the organization
• Forge effective partnerships with key stakeholders across business units (such as GBS)
• Advocate Team Lilly values while championing site-wide initiatives at LCCI in partnership with other site leaders

People Management and Organizational Development

• Provide leadership in recruiting, coaching and mentoring LCCI talent and integrating them into global teams
• Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in Clinical Data Sciences
• Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio
• Build an organizational culture that fosters inclusion and innovation.
• Develop staff who demonstrate expertise in drug development, therapeutic area science, project management and cross-functional leadership
• Develop an organizational talent base that demonstrates judgment based decision making, and provides leadership in clinical delivery
• Develop, mentor and coach future leaders and position these leaders to sustain operational excellence and future strategic transformations

Basic Qualifications:

• Bachelor's degree and 15-18 years of experience in clinical drug development with expertise in Data/Analytics
• At least 12 years of supervisory experience in Clinical Data Sciences
• 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 and capabilities.
• Demonstrated ability to effectively partner/influence cross functionally to deliver results
• Experience in leading and providing oversight to third parties for successful delivery of portfolio work

Additional Skills/Preferences:

• Broad expertise:  Data flow, analysis, and reporting processes; data and programming standards; emerging data capabilities and methods
• Broad clinical data-related credibility
• Ability to influence change
• Clear vision for data process transformation and automation
• Ability to unify and inspire people to achieve value-focused business objectives

Additional Information:

• Domestic and international travel required (5-10% per year), required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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