Director - Clinical Research Scientist – Immunology/Gastroenterology Development

Role Summary

The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Location: Indianapolis, IN.

Responsibilities

• Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule
• Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel.
• Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications.
• Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy.
• Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical.

Qualifications

• Required: An advanced health/medical/scientific degree (e.g., PharmD, PhD) or related graduate degree such as in 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
• Preferred: Strong oral/written communication and listening skills
• Preferred: Demonstrated ability to balance scientific priorities with business priorities and leadership examples
• Preferred: Strong relationship-building and interaction skills with peers and management

Skills

• Strong communication, interpersonal, teamwork, organizational, and negotiation skills
• Regulatory strategy and cross-functional collaboration
• Clinical trial design, start-up, monitoring, and reporting
• Data analysis and scientific publication preparation