Director - Clinical Research Scientist – Immunology/Gastroenterology Development

Role Summary

The Director - Clinical Research Scientist – Immunology/Gastroenterology Development leads late-phase clinical development programs for gastrointestinal indications within Lilly’s Immunology Development organization. The role focuses on planning and executing global late-stage trials, ensuring patient safety, regulatory alignment, and scientific integrity to support regulatory submissions and commercialization. The position requires strong expertise in drug development, cross-functional leadership, and the ability to manage complex programs from protocol design through publication.

Responsibilities

• Clinical Planning: develop product lifecycle plans, clinical strategies, development plans and study protocol design. Provide subject matter expertise and stay updated with relevant pre-clinical and clinical data.
• Clinical Trial Execution and Support: plan, collaborate on, and review scientific content of protocols, informed consent documents, final study reports, and submissions. Monitor patient safety and engage in global product safety reviews. Lead cross-functional collaboration with trial teams in mid-to-late phase trials. Conduct study start-up meetings, investigator meetings, and provide training/information to investigators and site personnel.
• Scientific Data Dissemination/Exchange: report clinical trial data in Clinical Trial Registry activities. Plan symposia, advisory board meetings, and other interactions with healthcare professionals. Build and maintain relationships with thought leaders. Support data analysis and publications.
• Regulatory Support Activities: provide medical expertise to regulatory scientists and support regulatory strategy.
• Scientific and Technical Expertise and Continued Development: act as scientific consultant and protocol expert for study teams and others in medical.

Qualifications

• Required: Advanced health/medical/scientific graduate degree (e.g., PharmD, PhD) or related field (Pharmacology, physiology, microbiology).
• Required: 3+ years of clinical development experience, including mid-to-late-stage development.
• Preferred: Previous GI drug development experience.
• Preferred: Pediatric drug development experience.

Skills

• Required: Strong communication, interpersonal, teamwork, organizational, and negotiation skills.
• Preferred: Demonstrated ability to balance scientific priorities with business priorities and examples of successful leadership.
• Preferred: Oral/written communication and listening skills; strong relationship-building and interaction skills with peers and management.
• Preferred: Indianapolis as a preferred location, with consideration for remote arrangements.

Education

• Advanced health/medical/scientific graduate degree (e.g., PharmD, PhD).