Sr. Director, Clinical Trial Foundations

2 months ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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.

Purpose:

Sr Director roles in Clinical Trial Foundations (CTF) focus on: Data capture; Data delivery; Site platforms, Monitoring and eTMF; External focus, management of pilots, and Transcelerate; and Business Process Management and OCM/Communications.

The Sr Director, CTF is a cross-functional leader and key partner across the business and for clinical information management capabilities. They will serve as the clinical system(s) owners and be 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 will actively engage with internal and external partners on new operating models, capabilities and technologies. The Sr. Director is responsible for collaborating with Process Owners and cross-functional leadership in the development of information management strategies and plans, and working with leadership and Third Party Organizations (TPO) to drive plan implementation. The main focus of this particular role will be focused on the development and implementation of the future state of data collection; including eCoa, EDC, Data Aggregation, and Electronic Medical Health records.

Primary Responsibilities:

Information Data Flow and System Ownership

Gain and maintain strategic alignment for clinical systems with the needs of all user communities and related initiatives. Define and manage clinical system 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 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 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 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, and other functions to effectively plan, forecast, and manage the sanctioned projects. Minimum Qualification Requirements: 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. Demonstrated ability to set and implement strategies and plans to improve complex drug development processes and capabilities. Strong background and understanding of the CDMS space; including data, processes, systems, and future-state business needs Qualified candidates must be legally authorized to be employed
in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment positionOther Information/Additional Preferences: Strong networking, interpersonal and relationship skills, with demonstrated ability to work in teams, across organizational boundaries and achieve results through others. Demonstrated credibility and ability to influence peers, management and senior leadership. Experience working with data collection systems (EDC, eCOa, EMR) and data aggregation tools Understanding of data management fundamentals; including data standards, data transfers, and data review Previous supervisory experience Previous experience with system ownership, implementation of new technology, business process automation Proven ability to develop and deliver both strategic and tactical plans Knowledge of emerging IT capabilities for clinical research Strong problem solving skills Flexibility to adjust quickly to changing business priorities 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 ( ) 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. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly

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