Associate Director/Director, Clinical Delivery Capabilities - EMP

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. Organization Overview: The Associate Director/Director, Clinical Delivery Capabilities plays a critical role in shaping how Lilly selects, manages, and partners with external vendors to ensure the quality and on-time delivery of its early-phase medicine portfolio. This role will work cross functionally to set the operational standards, systems, and processes that hold clinical research partners accountable and drive consistent, high-quality outcomes across every study in the pipeline. The purpose of the Associate Director/Director, Clinical Delivery Capabilities (CDC) role is to provide operational leadership to support exploratory and biopharmaceutics clinical development. The role works across the organization including with functional and organizational partner groups to deliver knowledge, expertise, standard templates, and technology to identify various clinical development scenarios and provide functional expertise to ensure successes of portfolio delivery .This role continually provides expertise in process and methodologies of Exploratory Medicine & Pharmacology (EMP) whilst looking for advancements and improvements. Key areas of responsibility of the role include: a) leading activities supporting study development and execution, b) cross-functional systems and processes, and c) systems, metrics and reporting. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the Associate Director/Director possesses the discernment, process knowledge, and influence required to lead in process and quality improvement efforts. The Associate Director/Director will seek knowledge from internal and external sources and use this information to drive strategic discussions with clinical and functional counterparts make recommendations to gain efficiencies and speed to shape development plans and improvement opportunities. Responsibilities: Study Development and Execution Support: Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies. The team will support study development by owning updates to corporate systems and processes e.g. CT Registry, Vault Clinical; trial and compound level documentation management e.g. eTMF and the contracting elements for a study. Provide leadership in business interactions with TPO partners; helping to implement the exploratory and biopharmaceutics clinical development portfolio. Lead and partner in the issue customer concern and relationship management processes, vendor and clinical research unit assessments as appropriate. Maintain awareness of regulatory issues and trends relevant to assigned portfolio. Systems and Processes Support: Provide leadership in business processes supporting early phase development. Established expertise on key business systems that support exploratory and biopharmaceutics clinical development. Review of established procedures across multiple subject areas, dependent on the change agendas to be evaluated and prioritized. Contribute to the overall strategic direction of cross-functional systems and process Draw on deep exploratory and biopharmaceutics clinical development knowledge and process expertise to review processes and when vital, sponsor improvement initiatives to increase business efficiency and value. Ensure cross-functional process alignment internally and externally where appropriate Act as a key resource to internal governance committees regarding processes applied in the exploratory and biopharmaceutics clinical development Ensure optimal network with the Quality, Clinical Information and Process Automation, and L&D organizations is established in order to guarantee processes deliver on Quality and Regulatory compliance requirements. Lead organizational change initiatives to ensure successful adoption of new clinical delivery capabilities, systems, and processes. Lead and collaborate with cross-functional teams to assess change impacts, develop communication strategies, and coordinate delivery of training. Act as a change advocate, helping collaborators navigate transitions and embedding change into team culture and workflows Systems, Metrics and Reporting: Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio results and assess process effectiveness Develop a metrics / measures and evaluation strategy for the organization. Establish and operationalize the processes to support this strategy e.g. scorecard generation Drive identification and development of emerging technologies to support the advancement of medicines to the clinic. e.g. Artificial Intelligence tools Review the implementation progress of implemented systems and/or recommend corrective actions, if needed. People Management and Employee Development: Attract, retain and develop a diverse workforce. Model behaviors and establish an environment where performance and results are valued, and where individuals are learning and growing developmentally. Seek opportunities to reward and recognize individuals and teams. Provide supportive environment for staff to explore innovative solutions to business problems and implement strategic and tactical decisions. Contribute to succession planning, talent assessment and performance/promotion processes. Ensure high talent staff are appropriately rewarded and developed. Coach and mentor department personnel, and as needed, cross-functional members, in order to affect development and growth of all team members. Minimum Qualification Requirements: Bachelor’s degree in a science related field from an accredited college or university; or equivalent qualifications/experience (3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, Project management and time management skills. Experience working cross-culturally and in a virtual work environment. Ability to travel (up to 10% expected – varies dependent on responsibilities) Other Information/Additional Preferences: Advanced scientific degree Ideally in exploratory and bio-pharmaceutics clinical development (5+ year preferred)). Solid understanding of regulations and guidelines that apply to the conduct of clinical trials. Direct supervisory experience Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships. Strong organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups. Strong verbal reasoning, attention to detail, critical thinking, problem solving, and analytical abilities. Proven experience of coaching and mentoring others. Deep expertise in one or more clinical research functions (clinical operations, sourcing, data sciences) Vendor management and contracting experience. Exploratory and biopharmaceutics clinical development, quality and Six Sigma experience preferred. Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates). Demonstrated experience in Organizational Change Management (OCM), with a strong ability to lead teams through transitions involving new systems, tools, or process changes. 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 ( 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly 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! #WeAreLilly