Associate Director, Clinical Research Lead (East Coast/Midwest)
Eli Lilly and Company
9 days ago
On-site
Charlotte, NC
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 quality, speed, and insight.
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.
- Build and sustain strategic, high-trust investigator relationships across trials/therapeutic areas.
- Co-create tailored recruitment strategies aligned with site capabilities, patient realities, and study objectives.
- Identify opportunities to reach new patients, accelerate enrollment, and increase impact 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 for predictable enrollment and data delivery.
- Use performance metrics to anticipate issues, intervene decisively, and maintain momentum.
- Drive inspection readiness across sites.
- Collaborate cross-functionally and with vendor partners to resolve operational barriers.
- Apply knowledge of local treatment paradigms/standard of care to influence site selection and protocol localization.
- Provide oversight/quality assurance for vendor monitoring; escalate risks.
- Where applicable, lead end-to-end Post-Marketing Safety Studies compliant with local regulations.
Business Management and Engagement:
- Cultivate a portfolio of high-impact investigators who prioritize Lilly trials.
- Provide an exceptional investigator experience as a responsive scientific partner.
- Collaborate cross-functionally to align on priorities and troubleshoot challenges.
- Conduct data-informed site prospecting and prioritization.
- Lead solutions-focused discussions using therapeutic expertise.
- Serve as liaison 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.
- Influence regulatory agility and operational feasibility.
- 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’ experience in clinical research or pharmaceutical industry with direct interaction with HCPs and clinical sites.
Preferred Qualifications/Skills:
- Advanced degree (PharmD, PhD, MD, or MSc).
- Experience in Neurodegeneration, Immunology, or Cardiometabolic Health.
- Strong GCP and clinical development/operations knowledge and trial lifecycle understanding.
- Ability to apply therapeutic landscape/standards of care to decision-making.
- Ability to build credibility and influence HCPs.
- Strategic, data-driven, and communicative; strong negotiation/organizational skills.
- English fluency and proficiency in local language(s) 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 quality, speed, and insight.
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.
- Build and sustain strategic, high-trust investigator relationships across trials/therapeutic areas.
- Co-create tailored recruitment strategies aligned with site capabilities, patient realities, and study objectives.
- Identify opportunities to reach new patients, accelerate enrollment, and increase impact 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 for predictable enrollment and data delivery.
- Use performance metrics to anticipate issues, intervene decisively, and maintain momentum.
- Drive inspection readiness across sites.
- Collaborate cross-functionally and with vendor partners to resolve operational barriers.
- Apply knowledge of local treatment paradigms/standard of care to influence site selection and protocol localization.
- Provide oversight/quality assurance for vendor monitoring; escalate risks.
- Where applicable, lead end-to-end Post-Marketing Safety Studies compliant with local regulations.
Business Management and Engagement:
- Cultivate a portfolio of high-impact investigators who prioritize Lilly trials.
- Provide an exceptional investigator experience as a responsive scientific partner.
- Collaborate cross-functionally to align on priorities and troubleshoot challenges.
- Conduct data-informed site prospecting and prioritization.
- Lead solutions-focused discussions using therapeutic expertise.
- Serve as liaison 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.
- Influence regulatory agility and operational feasibility.
- 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’ experience in clinical research or pharmaceutical industry with direct interaction with HCPs and clinical sites.
Preferred Qualifications/Skills:
- Advanced degree (PharmD, PhD, MD, or MSc).
- Experience in Neurodegeneration, Immunology, or Cardiometabolic Health.
- Strong GCP and clinical development/operations knowledge and trial lifecycle understanding.
- Ability to apply therapeutic landscape/standards of care to decision-making.
- Ability to build credibility and influence HCPs.
- Strategic, data-driven, and communicative; strong negotiation/organizational skills.
- English fluency and proficiency in local language(s) as needed.
Travel Requirements:
- Willingness to travel extensively (60–80%).