Eli Lilly and Company · 4 hours ago
Associate Director - Clinical Development (Oncology)
US, Indianapolis IN
Full-time
Onsite
Lead/Staff, Director/Executive
$123K/yr - $198K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. The Clinical Development Associate Director is responsible for executing integrated clinical development plans and leading the clinical team to ensure the successful delivery of clinical trial packages.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
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 Clinical Development Senior Director/Executive Director, Asset Team and Design Hub 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
Ensures collaboration with Design Hub and 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 in PRISM
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 indication-level; works closely with the CDTLs who are responsible for the trial-level grants and nongrants budgets and rolls-up budget information to Clinical Development Senior Director/Executive Director who is accountable for the total clinical plan budget
Responsible for completing the clinical assumptions within the UAT (unified assumptions tracker), attending PFA/PSE 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)
Align cross-functional resources based on portfolio prioritization inclusive of being flexible across therapeutic areas
Ensure Study Manager Competencies evolve and address implications to overall resource management and strategies
Maintains a state of inspection readiness for clinical development inclusive of 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 design hub and process improvements to process owners in the spirit of streamlining the efficiency and effectiveness of conducting clinical trials and non-trial work
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
Qualification
Required
Bachelor's degree, preferably in a scientific or health-related field
Minimum of 5 years' experience in the pharmaceutical industry and/or clinical development
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Preferred
Must understand clinical development processes and the interdependencies of various tasks that require coordination among asset team, design hub, functional/regional team members and third parties
Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelines
Strong communication skills; able to communicate clearly and succinctly with team members and leadership
Must be capable of managing staff virtually and across geographies/cultures
Proven ability to coach and develop others
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)
Project Management certification (e.g., PMP)
Previous supervisory experience strongly preferred
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
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
Benefits
Company bonus
401(k)
Pension
Vacation benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
Straits Times
2026-02-05
2026-02-05
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