Associate Director, Clinical Development Trial Lead (CDTL)
Eli Lilly and Company
6 hours ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Purpose
The Clinical Development Trial Lead (CDTL), Associate Director/Director independently leads the cross-functional study team in the development and execution of complex clinical trials, accountable regionally and globally to deliver clinical milestones with quality, on time, within scope, and within budget.
Responsibilities
- Use project management (scope, timeline, risk, budget) to develop and execute local, regional, and/or global clinical trials.
- Scope: Monitor trial status and adjust per change control to meet deliverables.
- Timeline: Develop and track global trial enrollment plan; align inputs across functions/geographies; consult CDTLs on Integrated Plans.
- Risk: Assess/identify/monitor trial-level risks and create integrated risk mitigation/contingency plans.
- Budget: Create and monitor grant and non-grant trial budgets/assumptions; use financial tracking tools; coordinate with business partners; support other CDTLs on budget items.
- Lead and influence large complex studies and/or multiple smaller studies.
- Partner on Investigator Study Specific Training (ISSTs) / Affiliate Study Training (ASTs).
- Drive cross-functional study team through implementation, execution, and closure, including proactive issue management and contingency planning.
- Own enrollment strategy/execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to meet enrollment goals.
- Serve as single point of contact/central owner for trial communication with CDDA, Regional Clinical Operations, and TPOs.
- Anticipate/resolve complex technical/operational or business problems; determine when escalation is needed.
- Identify and support continuous improvement based on industry/regulatory/technology trends.
- Make timely decisions for ambiguous/complex situations with a solution-oriented approach.
- Influence stakeholders to enable effective, timely decisions.
- Manage TPO qualification, selection, and oversight.
- Serve as the CRO point of contact; ensure CRO delivery of project achievements.
Clinical Trial Process Leadership and Expertise
- Influence study design and program-level decisions using therapeutic/clinical development and process expertise.
- Apply global/regional operating model; coordinate regional input to study teams.
- Maintain inspection-ready Trial Master File (TMF) for assigned trials.
- Ensure inspection readiness: document deviations timely; support storyboards/issue summaries for high-risk areas; coach CDTLs.
- Anticipate trial/regional issues and propose innovative approaches to mitigate risk.
- Coach peers/new CDTLs and cross-functional teams/TPOs on CT process and regional specificities.
- Maximize shared learning; lead process improvement; act as CDTL SME for rollout of tools/processes/methodologies.
- Report/manage/interpret trial information; ensure completeness/accuracy across systems and tools.
- Apply global/regional regulations, Good Clinical Practice (GCP), and Lilly standards; liaise to understand local regulatory requirements.
- Detect and resolve quality issues; escalate to functional leadership or consult Medical Quality/Legal/Compliance as needed.
Scientific Expertise
- Provide technical consultation for clinical and regulatory documents; support regulatory agency meetings and draft responses.
- Combine scientific/operational and process expertise to impact design, feasibility, and implementation.
- Apply clinical development foresight, problem-solving, and critical thinking.
- Serve as point of contact for Therapeutic Area and/or disease-state expertise.
Minimum Qualification Requirements
- Bachelor’s degree (scientific or health-related preferred).
- 5 years clinical research experience or relevant scientific/health-related experience; or an advanced degree.
Highly Desired Skills
- Applied knowledge of project management methodologies, processes, and tools.
- Ability to lead and work cross-culturally with global colleagues and TPOs.
- Coaching in process expertise.
- Flexibility and ability to lead through strategic organizational changes.
- Ability to influence without authority.
- Experience in cross-functional teams/projects and relationship management.
- Strong communication, self-management, and organizational skills.
- Ability to manage complex situations via problem-solving, critical thinking, and navigating ambiguity.
Other / Additional Preferences
- 5 years clinical trial experience with strong knowledge of clinical research process.
- Prior clinical trial site-level or affiliate experience.
- Prior experience with local/country regional requirements.
- Strong analytical skills.
- Experience with project management tools/techniques: Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI.
- Periodic travel to AST/ISST and potentially other scientific/regional meetings.
Benefits (if applicable)
- Full-time employees may be eligible for a company bonus (depending on company and individual performance).
- Comprehensive benefit program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, well-being benefits).
Compensation (anticipated)
- $115,500 - $169,400.
The Clinical Development Trial Lead (CDTL), Associate Director/Director independently leads the cross-functional study team in the development and execution of complex clinical trials, accountable regionally and globally to deliver clinical milestones with quality, on time, within scope, and within budget.
Responsibilities
- Use project management (scope, timeline, risk, budget) to develop and execute local, regional, and/or global clinical trials.
- Scope: Monitor trial status and adjust per change control to meet deliverables.
- Timeline: Develop and track global trial enrollment plan; align inputs across functions/geographies; consult CDTLs on Integrated Plans.
- Risk: Assess/identify/monitor trial-level risks and create integrated risk mitigation/contingency plans.
- Budget: Create and monitor grant and non-grant trial budgets/assumptions; use financial tracking tools; coordinate with business partners; support other CDTLs on budget items.
- Lead and influence large complex studies and/or multiple smaller studies.
- Partner on Investigator Study Specific Training (ISSTs) / Affiliate Study Training (ASTs).
- Drive cross-functional study team through implementation, execution, and closure, including proactive issue management and contingency planning.
- Own enrollment strategy/execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to meet enrollment goals.
- Serve as single point of contact/central owner for trial communication with CDDA, Regional Clinical Operations, and TPOs.
- Anticipate/resolve complex technical/operational or business problems; determine when escalation is needed.
- Identify and support continuous improvement based on industry/regulatory/technology trends.
- Make timely decisions for ambiguous/complex situations with a solution-oriented approach.
- Influence stakeholders to enable effective, timely decisions.
- Manage TPO qualification, selection, and oversight.
- Serve as the CRO point of contact; ensure CRO delivery of project achievements.
Clinical Trial Process Leadership and Expertise
- Influence study design and program-level decisions using therapeutic/clinical development and process expertise.
- Apply global/regional operating model; coordinate regional input to study teams.
- Maintain inspection-ready Trial Master File (TMF) for assigned trials.
- Ensure inspection readiness: document deviations timely; support storyboards/issue summaries for high-risk areas; coach CDTLs.
- Anticipate trial/regional issues and propose innovative approaches to mitigate risk.
- Coach peers/new CDTLs and cross-functional teams/TPOs on CT process and regional specificities.
- Maximize shared learning; lead process improvement; act as CDTL SME for rollout of tools/processes/methodologies.
- Report/manage/interpret trial information; ensure completeness/accuracy across systems and tools.
- Apply global/regional regulations, Good Clinical Practice (GCP), and Lilly standards; liaise to understand local regulatory requirements.
- Detect and resolve quality issues; escalate to functional leadership or consult Medical Quality/Legal/Compliance as needed.
Scientific Expertise
- Provide technical consultation for clinical and regulatory documents; support regulatory agency meetings and draft responses.
- Combine scientific/operational and process expertise to impact design, feasibility, and implementation.
- Apply clinical development foresight, problem-solving, and critical thinking.
- Serve as point of contact for Therapeutic Area and/or disease-state expertise.
Minimum Qualification Requirements
- Bachelor’s degree (scientific or health-related preferred).
- 5 years clinical research experience or relevant scientific/health-related experience; or an advanced degree.
Highly Desired Skills
- Applied knowledge of project management methodologies, processes, and tools.
- Ability to lead and work cross-culturally with global colleagues and TPOs.
- Coaching in process expertise.
- Flexibility and ability to lead through strategic organizational changes.
- Ability to influence without authority.
- Experience in cross-functional teams/projects and relationship management.
- Strong communication, self-management, and organizational skills.
- Ability to manage complex situations via problem-solving, critical thinking, and navigating ambiguity.
Other / Additional Preferences
- 5 years clinical trial experience with strong knowledge of clinical research process.
- Prior clinical trial site-level or affiliate experience.
- Prior experience with local/country regional requirements.
- Strong analytical skills.
- Experience with project management tools/techniques: Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI.
- Periodic travel to AST/ISST and potentially other scientific/regional meetings.
Benefits (if applicable)
- Full-time employees may be eligible for a company bonus (depending on company and individual performance).
- Comprehensive benefit program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, well-being benefits).
Compensation (anticipated)
- $115,500 - $169,400.