Associate Director- Clinical Central Services and Innovation US, Remote

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 and Innovation (CCSI) organization is responsible for enabling the delivery of community based research through developed deep expertise and oversight 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 and community event services and innovative location/site approaches to enable broader access to clinical trials with less burden for patients. 

The Associate Director of CCSI will collaborate and oversee the team focused on delivering the implementation of clinical capabilities including but not limited to mobile health care, telemedicine, virtual trial orchestration, recruitment & retention, new site models, central services and/or digital devices. The Associate Director provides supervision, leadership, direction and technical support to the team and serves as a communication conduit between our function, other functions, vendors and leadership. The Associate Director is accountable for the prioritization, planning, and implementation of deliverables across the team.

Responsibilities:

Capability Development and Delivery

• Create, grow and maintain team that supports clinical services and capabilities across functional and therapeutic areas.
• Manage clinical services and capabilities implementation and scale-up per the strategy and plan.
• Enable effective and efficient decision making across the team and with leadership.
• Anticipate and resolve operational issues for the team.
• Ensure team has work product sufficient to maintain a state of inspection readiness.

Organizational Leadership and External Focus

• Ensure corporate initiatives and programming are integrated into CCSI team operations and woven into performance management and development plans as appropriate for individuals.
• Manage functional networking, partnerships with functional areas and relationships with vendors to integrate and/or improve new or existing services and capabilities.
• Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning within CCSI and with functional areas.
   

People Management and Partnership

• Recruit, develop, and retain a diverse, clinical, technical and operationally capable workforce.
• Effectively manage an agile organization that continuously meets the needs of a changing portfolio.
• Build and maintain an organizational culture that fosters inclusion, innovation, and promotes diversity.
• Develop and manage staffing capacity modeler and apply and refine it over time.
• Ensure robust performance management, development and succession management plans are in place for each employee.

Basic Requirements:

• Bachelor’s degree
• 5 years of experience in clinical drug development.
• Strong working knowledge of GxP regulations and requirements (GMPs, GDPs and/or GCPs).
• Experience in supervision, coaching and/or mentoring others.
• Strong networking, interpersonal and relationship skills with demonstrated ability to work in teams, across organizational boundaries and achieve results through others.
• Previous cross functional experiences in 2 of the following areas: Clinical Capabilities, clinical research, clinical trial material and supplies, R&D, Quality or related areas.

Additional Skills/Preferences:

• Demonstrated strong and effective written and verbal communication skills in multi-cultural and cross functional settings
• Ability to build productive relationships and effectively communicate cross functionally
• Ability to work in an independent, flexible environment
• Strong working knowledge of GCP regulations and GXP requirements
• Previous Quality experience
• Clinical and Submission experience
• Business Unit team experience
• Demonstrated organizational change management
• Previous Label and Regulatory experience
• Project management
• Must speak fluent English

Additional Information:

• Demonstrated business acumen (financial oversight, business development, business planning).
• Knowledge of emerging health care related services and capabilities for clinical research.
• Strong project management skills.
• Flexibility to adjust quickly to changing business priorities.
• Work outside of core hours may be required to support the portfolio across the globe.
• May require travel domestically & internationally.

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

$118,500 - $173,800

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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