Position Summary
The Associate Director, Clinical Development Trial Lead (CDTL) independently leads cross-functional study teams to develop and execute complex clinical trials and is accountable regionally and globally to deliver clinical milestones with quality, on time, and within scope/budget.
Responsibilities
- Lead local/regional/global clinical trials using project management skills: scope, timeline/enrollment, risk, and budget (grants/non-grants).
- Lead and influence large/complex studies (or multiple smaller studies) and drive proactive issue management, contingency planning, and resolution.
- Accountable for enrollment strategy/execution from country allocation through LPET; partner with Regional Operations to achieve enrollment goals.
- Manage TPO qualification/selection/oversight; serve as CRO clinical development point of contact to ensure CRO milestone delivery.
- Ensure inspection readiness, Trial Master File accountability, deviation documentation, and issue/storyboard creation; coach CDTLs.
- Apply knowledge of global/regional regulations, GCP, and Lilly standards; independently detect and resolve quality issues.
- Provide technical/regulatory consultation for clinical/regulatory documents and support regulatory agency interactions.
Minimum Qualifications
- Bachelorβs degree (scientific/health-related preferred).
- 5+ years clinical research (or relevant scientific/health experience).
- Authorized to work in the U.S. (Lilly does not sponsor visas).
- Onsite required at Stamford, CT or Indianapolis, IN (relocation assistance may be available).