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 Clinical Central Services & Innovation (CCSI) organization is responsible for strategically planning and providing trial support services, clinical trial supplies and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This organization enables innovative and foundational solutions including but not limited to central pharmacy services, mobile healthcare, telemedicine, virtual trial orchestration, recruitment & retention, community screening, new site models, and digital devices. Our mission is to increase clinical research awareness and diversity while reducing the
patient and investigator burden in order to speed medicines to those in need. This group is within the broader Clinical Capabilities organization and partners across functions within Clinical Design, Delivery and Analytics (CDDA) and Product Research and Development (PRD) to influence trial design and provide solutions to operationalize these trials and enable asset
strategies across the portfolio.

Responsibilities:
The CCSI Associate Director is focused on the operations strategy and implementation for these capabilities. They will be responsible to drive the processes and oversee partnering with the clinical & design organizations to provide patient services like pharmacy and medical benefit
coverage, direct-to-patient CT material delivery, and community-based research support. This role will also participate in maintenance and interpretation of decentralized trial regulations, clinical trial material regulations while working with global regulatory to align a consistent strategy across the portfolio. This role will also be responsible for vendor management and
collaboration to drive implementation and coordinate efforts across the clinical capabilities’ teams.

Capability Development and Delivery

Serve as Operational Lead, develop business strategies, processes, and technology as it relates to clinical central services & innovation
Partner with study teams, external partners, and vendors to develop innovative solutions for the delivery of trial activities and services at alternative site locations (e.g., patient home, community health center or other HCP location)
Partner with Clinical, Regulatory, Product Delivery, Quality, Procurement, Finance, BU’s and other MDU functions to clearly understand the clinical trial requirements and patient needs to inform decisions around which capabilities best meet those requirements
Provide expertise of global regulations governing decentralized clinical research at community based health and alternative site locations including the distribution of pharmaceutical products and other trial supplies and develop a strategic plan to comply with them
Continuously maintain a state of inspection readiness. Participate and perform duties required for internal and external inspections as well as supporting institutions/investigators and alternative site locations in inspection readiness initiatives
Drive benchmarking, continuous improvement, shared learning, and process expertise between teams
Develop critical success factors for pilot programs/projects and monitor progress to ensure clear criteria exists to enable decision making

Project Management

Understand business and financial acumen while minimizing the risk, delays, and potential interruption of clinical trial programs
Maintain operational alignment and prioritization for clinical services across functional and therapeutic areas
Develop critical success factors for pilots/projects and monitor progress to ensure clear criteria exists to enable decision making
Provide guidance and consulting into forecasting and managing expenses.
Identify project implementation risks and raise issues appropriately.
Lead progress reporting activities and metrics
Manage Third Party Organization qualification process, selection, oversight

Partnership

Foster inclusion, innovation, and promote diversity
Partner closely within and across teams to effectively plan, forecast, and manage the portfolio and project work
Collaborate with vendors and other external partners to improve customer experience and monitor performance
Lead organizational change, communication planning and training initiatives.
Identify, monitor, and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements

Basic Requirements:

Bachelor’s degree and/or 3 to 5 years of industry or health care related experience (regulatory affairs and/or project management, clinical drug development or a healthcare related field)
Knowledge of drug development process
Strong networking, interpersonal and relationship skills with demonstrated ability to work in teams, across organizational boundaries and achieve results through others • Previous experience in a community health care setting

Additional Preferences:

Knowledge of emerging healthcare related services and capabilities for clinical research
Knowledge of country regulatory guidelines/requirements for clinical research conduct
License/Certificate Requirements: PharmD preferred
Language Requirements: Must speak fluent English

Additional Information/Requirements:

Work outside of core hours may be required to support the portfolio across the globe
May require travel domestically and international (less than 10%)

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 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.

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Associate Director - Clinical Central Services & Innovation