Associate Director-Clinical Development-Immunology
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: January 14, 2026
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Job Description:
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. Responsibilities: The
Associate Director Clinical Development is responsible for
executing integrated clinical development plans (i.e.
compound/indication-level) and clinical trial packages that are
aligned with the asset team which will be achieved through clinical
development expertise and effective partnership with the Senior
Director/Executive Director Clinical Development, Asset Team and
Clinical Design. The Associate Director Clinical Development will
lead the asset/indication clinical team who are responsible for the
execution and delivery of the clinical package and provide
direction, leadership and technical/process expertise to their
staff. The Associate Director Clinical Development in partnership
with Senior Director/Executive Director Clinical Development will
model and reinforce the leadership behaviors and ensure career
development of staff. Primary Responsibilities Clinical Planning
Responsible for clinical development of the assigned compound
and/or indication from asset strategy through submission,
inspection, approval and post-launch support. Collaborates with the
Senior Director/Executive Director Clinical Development, Asset Team
and Clinical Design to accelerate execution of the complete trial
package (scope, timeline, budget and risk management). Lead the
global clinical submission strategy, including scope, timeline,
resource and risk management. Clinical Execution Ensures
collaboration with Clinical Design and Clinical Development Trial
Lead (CDTL) and other cross-functional MDU team members for
effective transition of clinical trial package to execution and
clinical delivery. Responsible for execution and delivery of the
global clinical submission plan, including communications to team
and leadership, resource and risk management. Responsible for
executing clinical plan/trial to the approved timeline; ability to
understand the critical chain methodology and use its functionality
to manage program/trial; ability to make updates to the critical
chain. Manages risks plans at the indication/trial-level during the
implementation in response to new data and changes in the
environment. Responsible for budget planning, monitoring and
control of the total trial budget at the compound and or
indication-level; works closely with the CDTLs who are responsible
for the trial-level grants and nongrants budgets and rolls-up
budget information to Senior Director/Executive Director Clinical
Development who is accountable for the total clinical plan budget.
Responsible for completing the clinical assumptions within the UAT
(unified assumptions tracker), attending financial meetings, and
ensuring that the total trial budgets are accurate. Manages global
cross-functional communication and escalations to ensure alignment
on delivery and execution. Utilizes regulatory and process
knowledge to drive decision making. Establishing and managing
partner expectations, performance and delivery (i.e. CRO, Alliances
and Joint Ventures). Effective Management Align cross-functional
resources based on portfolio prioritization inclusive of being
flexible across therapeutic areas. Ensure Clinical Development
Trial Lead Competencies evolve and address implications to overall
resource management and strategies. Maintains a state of inspection
readiness for clinical development inclusive of the Trial Master
File (TMF). Models judgement-based decision-making to navigate
compliance and quality requirements. Responsible for continuous
improvement in the following: clinical development, complete trial
packages from the Clinical Design and process improvements to
process owners in the spirit of streamlining the efficiency and
effectiveness of conducting clinical trials and non-trial work.
People Management Recruit, develop and retain a diverse and highly
capable workforce Build an organizational culture that fosters
inclusion Support and encourage talent identification, development
and retention that reflects an end-to-end process mindset and
demonstrates judgement-based decision making. Ensure robust
training plan and timely completion of required training for direct
reports. Minimum Qualifications : Bachelor's degree, preferably in
a scientific or health-related field 5 years in the pharmaceutical
industry and/or clinical development 5 years project management
experience across the clinical trial landscape 3 years managing a
team of direct reports virtually and across geographies/cultures
Experience managing clinical development processes and associate
tasks 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 position. Other Information/Additional
Preferences: Project Management certification (e.g., PMP) Previous
supervisory experience Proven ability to coach and develop others
Prior experience in working with a non-Lilly business partner
(e.g., CRO, Alliance, Joint Venture) Prior submission and
inspection experience Prior experience with the management of
business plans Ability to embrace the diversity of thought to model
innovative behaviors (e.g. reaching across boundaries, inspire and
empower others and lead decisively in the midst of ambiguity)
Strong self-management and organizational skills; able to manage
workload, set personal and team priorities and adjust as needed
Able to influence others without direct authority Strong
problem-solving skills; able to anticipate and recognize systemic
problems, diagnose root causes and take corrective actions to
prevent reoccurrence Travel may be required 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 $123,000 -
$180,400 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
Keywords: Eli Lilly and Company, Lafayette , Associate Director-Clinical Development-Immunology, Science, Research & Development , Indianapolis, Indiana