Associate Director, Clinical Research Lead (East Coast/Midwest)
Eli Lilly and Company
9 days ago
On-site
Atlanta, GA
Clinical Research and Development
Purpose
The Clinical Research Lead (CRL) is a strategic, field-based scientific leader responsible for driving execution of Lilly clinical trials through investigator engagement and site performance management, ensuring trials are delivered with quality, speed, and insight.
Primary Responsibilities
Clinical Investigator Management
- Accountable for investigator engagement from identification/qualification through enrollment, support for database lock, and study closeout.
- Ensure investigators understand protocol intent, scientific rationale, and patient eligibility requirements.
- Build and sustain high-trust, strategic relationships across trials and therapeutic areas.
- Influence enrollment via tailored recruitment strategies aligned to site capabilities and study objectives.
- Find opportunities to reach new patients and accelerate enrollment at priority sites.
- Capture and elevate site insights to optimize feasibility, protocol design, and study conduct.
Clinical Trial Management
- Lead site-level strategy and risk planning to ensure predictable enrollment and data delivery.
- Use performance metrics to anticipate issues and maintain momentum to milestones.
- Drive inspection readiness across sites.
- Collaborate with internal functions and vendors to remove operational barriers.
- Apply knowledge of local treatment paradigms/standard of care for country/site selection and protocol localization.
- Provide oversight and quality assurance for vendor monitoring; escalate risks.
- Where applicable, lead end-to-end Post-Marketing Safety Study management in compliance with local regulations.
Business Management and Engagement
- Cultivate a portfolio of high-impact investigators who prioritize Lilly trials.
- Enable exceptional investigator experience as a responsive scientific partner.
- Collaborate cross-functionally to align priorities and troubleshoot challenges.
- Conduct data-informed site prospecting and prioritization.
- Lead solutions-focused discussions with site personnel.
- Liaise between field teams, vendors, and investigators to ensure alignment and knowledge transfer.
Country/Regulatory Engagement (where applicable)
- Represent Investigator Engagement with regulatory agencies, ethics committees, and national research organizations.
- Translate local requirements into compliant, efficient trial execution.
Minimum Qualifications
- Bachelor’s degree or equivalent (strong preference for scientific/clinical/health-related fields).
- 5+ years of clinical research or pharmaceutical industry experience interacting with HCPs and clinical sites.
Preferred Qualifications / Skills
- Advanced degree (PharmD, PhD, MD, or MSc).
- Experience in Neurodegeneration, Immunology, or Cardiometabolic Health.
- Strong understanding of GCP, clinical development/operations, and trial lifecycle.
- Ability to apply therapeutic landscape/standards of care to decision-making.
- Credibility and influence with HCP community; strategic, data-driven decision-making.
- Excellent communication, negotiation, and organizational skills.
- Experience influencing site performance and driving enrollment success.
- Experience working with regulators or national bodies.
- English fluency and local language proficiency as needed.
Travel Requirements
- Willingness to travel extensively (60–80%).
The Clinical Research Lead (CRL) is a strategic, field-based scientific leader responsible for driving execution of Lilly clinical trials through investigator engagement and site performance management, ensuring trials are delivered with quality, speed, and insight.
Primary Responsibilities
Clinical Investigator Management
- Accountable for investigator engagement from identification/qualification through enrollment, support for database lock, and study closeout.
- Ensure investigators understand protocol intent, scientific rationale, and patient eligibility requirements.
- Build and sustain high-trust, strategic relationships across trials and therapeutic areas.
- Influence enrollment via tailored recruitment strategies aligned to site capabilities and study objectives.
- Find opportunities to reach new patients and accelerate enrollment at priority sites.
- Capture and elevate site insights to optimize feasibility, protocol design, and study conduct.
Clinical Trial Management
- Lead site-level strategy and risk planning to ensure predictable enrollment and data delivery.
- Use performance metrics to anticipate issues and maintain momentum to milestones.
- Drive inspection readiness across sites.
- Collaborate with internal functions and vendors to remove operational barriers.
- Apply knowledge of local treatment paradigms/standard of care for country/site selection and protocol localization.
- Provide oversight and quality assurance for vendor monitoring; escalate risks.
- Where applicable, lead end-to-end Post-Marketing Safety Study management in compliance with local regulations.
Business Management and Engagement
- Cultivate a portfolio of high-impact investigators who prioritize Lilly trials.
- Enable exceptional investigator experience as a responsive scientific partner.
- Collaborate cross-functionally to align priorities and troubleshoot challenges.
- Conduct data-informed site prospecting and prioritization.
- Lead solutions-focused discussions with site personnel.
- Liaise between field teams, vendors, and investigators to ensure alignment and knowledge transfer.
Country/Regulatory Engagement (where applicable)
- Represent Investigator Engagement with regulatory agencies, ethics committees, and national research organizations.
- Translate local requirements into compliant, efficient trial execution.
Minimum Qualifications
- Bachelor’s degree or equivalent (strong preference for scientific/clinical/health-related fields).
- 5+ years of clinical research or pharmaceutical industry experience interacting with HCPs and clinical sites.
Preferred Qualifications / Skills
- Advanced degree (PharmD, PhD, MD, or MSc).
- Experience in Neurodegeneration, Immunology, or Cardiometabolic Health.
- Strong understanding of GCP, clinical development/operations, and trial lifecycle.
- Ability to apply therapeutic landscape/standards of care to decision-making.
- Credibility and influence with HCP community; strategic, data-driven decision-making.
- Excellent communication, negotiation, and organizational skills.
- Experience influencing site performance and driving enrollment success.
- Experience working with regulators or national bodies.
- English fluency and local language proficiency as needed.
Travel Requirements
- Willingness to travel extensively (60–80%).