Associate Director – Clinical Development, Oncology

Eli Lilly and Company

. Independently lead cross-functional study teams in the development and execution of complex clinical trials .

Posted 11/10/2026full-timeIndianapolis • Connecticut • United StatesSenior💰 $117,000 - $171,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in leading complex clinical trials, managing cross-functional teams, and ensuring compliance with global regulations and Good Clinical Practice. Proficient in project management methodologies and tools, with a strong focus on enrollment strategies and process improvements.

Highest-signal resume keywords

Clinical Trial ManagementProject Management MethodologyOncology BackgroundProcess Improvement ExperienceCross-Functional Team Leadership

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Research ExperienceTrial Budget ManagementRisk Assessment and MitigationTrial Enrollment StrategyRegulatory Document PreparationData InterpretationTherapeutic Area ExpertiseCRO OversightQuality Issue ResolutionTrial Master File Maintenance

Soft Skills

Effective CommunicationAnalytical SkillsProblem-SolvingSelf-ManagementOrganizational Skills

Tools & Technologies

VeevaMS ProjectMS ExcelMS PowerPointPowerBIAI-Powered Tools

Industry Keywords

Good Clinical PracticeCAR-TClinical Drug DevelopmentCross-Cultural LeadershipLocal/Regional Requirements

About the role

Key responsibilities & impact

Independently lead cross-functional study teams in the development and execution of complex clinical trials
Deliver clinical milestones on time, with quality, within scope and budget
Develop and track global trial enrollment plans
Assess, identify, and monitor trial-level risks and create integrated mitigation and contingency plans
Create and monitor trial budgets and coordinate with business partners on budget status and changes
Lead and project manage large, complex studies and/or multiple smaller studies
Coordinate and participate in Investigator Study Specific Training and Affiliate Study Training
Drive local, regional, and global cross-functional study teams through implementation, execution, and closure
Own trial/regional/program/molecule enrollment strategy and execution
Partner with Regional Operations to achieve enrollment goals
Serve as the central owner and point of contact for trial communications
Resolve complex technical, operational, and business problems and determine escalation needs
Manage third-party organization qualification, selection, and oversight
Serve as the CRO clinical development point of contact for outsourced trial execution
Ensure CRO delivery of project milestones
Influence study design and program-level decisions using therapeutic, clinical drug development, and process expertise
Maintain assigned Trial Master Files and ensure inspection readiness
Document deviations and create storyboards or issue summary documents
Identify and lead process improvement activities and support new tools, processes, and methodologies
Report, manage, and interpret clinical trial information across business systems and tools
Apply global and regional regulations, Good Clinical Practice, and Lilly operating standards
Detect and resolve quality issues, consulting functional leadership and other functions as needed
Prepare or provide technical consultation for clinical and regulatory documents
Prepare for regulatory agency meetings and draft responses to agency, TPO, and affiliate questions
Provide therapeutic area and/or disease state expertise
Coach peers, new CDTLs, cross-functional team members, and TPOs

Requirements

What you’ll need

Bachelor's degree
5 years clinical research experience or relevant experience in a scientific or health-related field
Authorized to work in the United States on a full-time basis
Applied knowledge of project management methodology, processes, and tools
Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
Oncology background
CAR-T background
Prior clinical trial site-level or affiliate experience
Prior experience with local/country regional requirements
Strong analytical skills
Proficiency in project management tools and techniques, including Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, and PowerBI
Ability to use AI-powered tools and technologies
Ability to travel periodically to AST/ISST and potentially other scientific/regional meetings
Demonstrated process improvement experience
Ability to lead and work effectively cross-culturally with global colleagues and TPOs
Ability to coach others in process expertise
Ability to influence without authority
Experience working in cross-functional teams/projects or ability to establish and manage relationships
Effective communication, self-management, and organizational skills
Ability to manage complex situations through problem-solving, critical thinking, and navigating ambiguity

Benefits

Comp & perks

Company bonus depending on company and individual performance
Medical, prescription drug, dental, and vision coverage
Mental health support and concierge services
Fitness membership, health coaching, and wellness activities
Defined benefit pension
401(k) match
Retiree medical coverage
Life and disability insurance
Paid time off for personal illness, caregiver, bereavement, and other family needs
Annual paid vacation and holidays
Flexible benefits, including healthcare and dependent day care flexible spending accounts
Employee assistance program
Fitness benefits and employee clubs and activities