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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:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Purpose:

The Clinical Central Services and Innovation (CCSI) organization is responsible for enabling the delivery of community based research through developed deep therapeutic area expertise and application of central capabilities including but not limited to: Logistics relative to patient centered capabilities (examples include but are not limited to study navigation, patient concierge services, central study coordinators); Non-Imp (Investigational Medicinal Product) supply planning and logistics delivery (examples include but are not limited to ancillaries, study start up kits, patient start up kits, visit specific kits, patient retention items, eCOA devices); Community based delivery through centralized capabilities such as mobile research units and innovative location/site approaches to enable broader access to clinical trials with less burden for patients.

This group is within the Clinical Capabilities organization. Through strong partnership and collaboration across Clinical Design, Delivery & Analytics (CDDA) and the Business Units in all phases of development, this organization aligns delivery of capabilities to trial design needs globally. The group influences and partners with industry colleagues and regulators to shape the external environment and enable broader access to clinical trials. The Sr. Director promotes understanding of global regulations and the external environment impacting community-based delivery. This role establishes processes and practices for continual monitoring and oversight to ensure continuous quality, data integrity, human protection, undue influence, and privacy are maintained. Responsibilities include but are not limited to partnering with global functional leaders to translate therapeutic area and portfolio needs to discover, develop, and implement clinical central services in support of community-based research.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Central Clinical Services Leadership

Responsible for the continued strategy, development, optimization, and oversight of Central Clinical Services capabilities.

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.

Make complex decisions that involve vendors, cross-functional areas, or are considerable risk.

Build relationships to enable an optimized investigator and participant experience.

Influence vendors on technology and service-related offerings.

Lead new capabilities outlining key performance indicators and decision gates for continued usage and scale.

Manage overall risk identification and mitigation within capability area.

Define and manage budget for Central Clinical Services.

Creates culture of customer centricity; ensures participant and site personnel issues are escalated appropriately

Enterprise Leadership and External Focus

Build strong functional networks with clinical leaders/representatives to integrate new or existing services and capabilities based on evolving portfolio and business needs.

Influence the external environment including regulators, institutions, institutional review boards, ethics committees, investigators, vendors, etc.

Drive continuous improvement, shared learning and process expertise between teams and across the organization.

Responsible for identification of metrics evaluating participant, partner, investigator, and central rater experience.

Identifies short- and longer-term trends impacting this capability area.

People Management and Development

If applicable, recruit, develop, and retain a diverse, clinical, technical and operationally capable workforce.

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 to effectively plan, forecast, and manage the portfolio and project work.

Basic Requirements:

Bachelor’s degree in a scientific field or health-related field

5 years’ experience in Clinical Trials/Development and good working knowledge of Good Clinical Practice

3+ years’ experience in working with and managing CROs or external vendors for the execution of clinical trials

Additional Preferences:

Demonstrated leadership skills with ability to influence, achieve results through others and lead across the business and across regions/geographies

Experience in supervision, coaching and mentoring others

Demonstrated business acumen (financial oversight, business development, business planning).

Effective communication (both verbal and written) and language skills – ability to communicate effectively up and down in the organization

Strong organizational/planning skills

Fluent in English [Fluency in Spanish is a bonus]

Knowledge of country regulatory guidelines/requirements for clinical research conduct

Strong interpersonal skills

Demonstrated decision-making ability

Ability to develop and apply creative solutions

Experience in working cross-culturally and with virtual teams

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

$151,500 - $222,200

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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