Clinical Research Lead – Immunology, Investigator Engagement

This is a fully remote position, open to applicants in California.

📋 Description

• Lead the execution of Lilly clinical trials by engaging investigators and managing site performance.

• Oversee investigator engagement from the stages of identification and qualification through to enrollment, database lock support, and study closure.

• Ensure that investigators comprehend the intent of the protocol, the scientific rationale, and the requirements for patient eligibility.

• Develop and maintain strategic relationships with investigators across various trials and therapeutic areas.

• Collaborate to create customized recruitment strategies and identify new patient outreach opportunities to accelerate enrollment.

• Capture and communicate site insights to enhance feasibility, protocol design, and the conduct of the study.

• Lead the strategy and risk planning at the site level for enrollment and data delivery.

• Utilize performance metrics to foresee potential issues, intervene when necessary, and uphold the momentum of clinical milestones.

• Promote continuous readiness for inspections across all sites.

• Work closely with internal teams and vendors to overcome operational challenges and ensure quality delivery.

• Influence the selection of countries/sites and the localization of protocols by incorporating local treatment paradigms and standards of care.

• Provide oversight and quality assurance for vendor monitoring while proactively escalating risks.

• Where applicable, manage Post-Marketing Safety Studies from start to finish while adhering to local regulations.

• Cultivate a strategically aligned portfolio of impactful investigators.

• Act as a scientific liaison among field teams, vendors, investigators, regulatory agencies, ethics committees, and national research organizations when necessary.

• Contribute to regional initiatives and overall success in clinical development across the enterprise.

⛳️ Requirements

• Bachelor's degree or equivalent; a background in scientific, clinical, or health-related fields is highly preferred.

• At least 5 years of experience in clinical research or the pharmaceutical industry.

• Proven experience in direct interaction with healthcare professionals and clinical sites.

• Must be based in California to support the West Coast Region.

• An advanced degree in a scientific or clinical field, such as PharmD, PhD, MD, or MSc, is preferred.

• Experience in immunology therapeutic areas, such as dermatology, allergy, or respiratory is a plus.

• Strong understanding of GCP, clinical development and operations, along with the trial lifecycle.

• Knowledge of therapeutic landscapes and standards of care.

• Ability to establish credibility and influence healthcare professional communities through scientific knowledge and relationships.

• Capability for data-driven decision-making and interpreting operational and performance metrics.

• Exceptional communication, negotiation, and organizational skills.

• In-depth therapeutic-area expertise and familiarity with local clinical research ecosystems.

• Experience in influencing clinical site performance and driving enrollment success.

• Proven track record of achieving or surpassing performance targets in a collaborative matrix environment.

• Experience working with regulators or national bodies to support the delivery of clinical trials.

• Proficiency in English and local language(s) as necessary.

• Willingness to travel extensively (60-80%).

🏝️ Benefits

• Company bonus, partially based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug benefits.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including employee assistance programs, fitness benefits, and various employee clubs and activities.

• Employee resource groups and support networks.