Associate Director - Clinical Development Trial Lead (CDTL)
Eli Lilly and Company
18 days ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Purpose
The Clinical Development Trial Lead (CDTL), Associate Director independently leads cross-functional study teams in the development and execution of complex clinical trials, accountable regionally and globally to deliver clinical milestones with quality, on time, within scope and budget.
Primary Responsibilities
- Use project management skills/tools to develop and execute local/regional/global clinical trials: scope, timeline/enrollment planning, risk mitigation/contingency, and trial-level budget/grants & non-grants.
- Lead and influence large complex studies and/or multiple smaller studies.
- Coordinate Investigator Study Specific Training (ISSTs) / Affiliate Study Training (ASTs).
- Drive cross-functional study team through implementation, execution, and closure; proactive issue management, contingency planning, and issue resolution.
- Own enrollment strategy/execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to achieve enrollment goals.
- Serve as single point of contact/central owner for trial communication (to/from CDDA, Regional Clinical Ops, and Third-Party Organizations (TPOs)); manage/influence upward.
- Anticipate and resolve complex technical/operational or business problems; determine issues for escalation; manage TPO qualification/selection/oversight.
- Serve as CRO clinical development point of contact for outsourced execution; ensure CRO delivery of milestones.
Clinical Trial Process Leadership and Expertise
- Influence study design and program decisions using therapeutic/clinical drug development and process expertise.
- Single point accountability for Trial Master File; ensure inspection readiness and timely deviation documentation/storyboards/issue summaries.
- Apply global/regional regulations, GCP, and Lilly standards; resolve quality issues via appropriate escalation.
- Provide technical consultation for clinical/regulatory documents and support regulatory agency interactions.
Scientific Expertise
- Impact trial design/feasibility/implementation using scientific and operational knowledge; act as contact for therapeutic area/disease-state expertise.
Minimum Qualifications
- Bachelor’s or University degree (scientific/health-related preferred) + 5 years clinical research experience (or relevant scientific/health-related experience); or an advanced degree.
- Must be authorized to work in the U.S. full-time; Lilly does not sponsor visas/work authorization.
Highly Desired Skills / Other Preferences
- Project management methodology/process/tools knowledge.
- Ability to lead cross-culturally with global colleagues and TPOs; coach others.
- Influence without authority; experience in cross-functional teams/projects.
- Strong communication, self-management, organizational skills; problem-solving in ambiguity.
- Prefer: 5+ years clinical trial experience, oncology background, site/affiliate experience, local/country requirements, strong analytics.
- Tools: Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI; periodic travel to AST/ISST.
Benefits (as stated)
- Full-time employees may be eligible for a company bonus and a comprehensive benefits program (401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being like EAP/fitness).
The Clinical Development Trial Lead (CDTL), Associate Director independently leads cross-functional study teams in the development and execution of complex clinical trials, accountable regionally and globally to deliver clinical milestones with quality, on time, within scope and budget.
Primary Responsibilities
- Use project management skills/tools to develop and execute local/regional/global clinical trials: scope, timeline/enrollment planning, risk mitigation/contingency, and trial-level budget/grants & non-grants.
- Lead and influence large complex studies and/or multiple smaller studies.
- Coordinate Investigator Study Specific Training (ISSTs) / Affiliate Study Training (ASTs).
- Drive cross-functional study team through implementation, execution, and closure; proactive issue management, contingency planning, and issue resolution.
- Own enrollment strategy/execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to achieve enrollment goals.
- Serve as single point of contact/central owner for trial communication (to/from CDDA, Regional Clinical Ops, and Third-Party Organizations (TPOs)); manage/influence upward.
- Anticipate and resolve complex technical/operational or business problems; determine issues for escalation; manage TPO qualification/selection/oversight.
- Serve as CRO clinical development point of contact for outsourced execution; ensure CRO delivery of milestones.
Clinical Trial Process Leadership and Expertise
- Influence study design and program decisions using therapeutic/clinical drug development and process expertise.
- Single point accountability for Trial Master File; ensure inspection readiness and timely deviation documentation/storyboards/issue summaries.
- Apply global/regional regulations, GCP, and Lilly standards; resolve quality issues via appropriate escalation.
- Provide technical consultation for clinical/regulatory documents and support regulatory agency interactions.
Scientific Expertise
- Impact trial design/feasibility/implementation using scientific and operational knowledge; act as contact for therapeutic area/disease-state expertise.
Minimum Qualifications
- Bachelor’s or University degree (scientific/health-related preferred) + 5 years clinical research experience (or relevant scientific/health-related experience); or an advanced degree.
- Must be authorized to work in the U.S. full-time; Lilly does not sponsor visas/work authorization.
Highly Desired Skills / Other Preferences
- Project management methodology/process/tools knowledge.
- Ability to lead cross-culturally with global colleagues and TPOs; coach others.
- Influence without authority; experience in cross-functional teams/projects.
- Strong communication, self-management, organizational skills; problem-solving in ambiguity.
- Prefer: 5+ years clinical trial experience, oncology background, site/affiliate experience, local/country requirements, strong analytics.
- Tools: Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI; periodic travel to AST/ISST.
Benefits (as stated)
- Full-time employees may be eligible for a company bonus and a comprehensive benefits program (401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being like EAP/fitness).