Sr. Director - Clinical Development

Role Summary

This Clinical Research Physician (CRP) role within the Immunology/Gastroenterology therapeutic area supports early and late phase clinical trials for assets in the gastroenterology pipeline. The CRP participates in the development, conduct and reporting of corporate/global clinical trials, implementation of global clinical trials, adverse event reporting, protocol and publication reviews, and strategic medical activities to support product demand realization. The CRP serves as a scientific resource for study teams, ensuring all activities comply with applicable regulations, GCPs, and Lilly policies, and aligns with the medical vision.

Responsibilities

• Clinical Planning: Collaborate across regions and functions to develop and maintain launch label/value propositions, lifecycle plans, clinical strategies, development plans, and study protocol designs; contribute to global clinical strategy alignment; stay updated with relevant pre-clinical and clinical data.
• Clinical Research/Trial/Execution and Support: Plan, review, and provide scientific input for protocols, informed consent documents, final study reports, and submissions; oversee and input into informed consent; collaborate on local trial design and governance; assess risk profiles; participate in investigator identification and site initiation activities; ensure completion of administrative requirements in accordance with GCPs and local laws; train investigators and site personnel; support operations and vendor interactions; monitor patient safety and adverse events; review proposals and publications as requested by Medical leadership.
• Scientific Data Dissemination/Exchange: Ensure compliance with data dissemination policies; address informational needs of external healthcare professionals; assist with clinical trial data reporting and planning of symposia and medical communications; support preparation of medical letters and materials; respond to inquiries from healthcare professionals; support data analysis, slide development, and publications; foster collaborations with external experts and professional societies; participate in data dissemination activities and final reports/publications; provide congress support and customer-facing scientific input.
• Regulatory Support Activities: Develop and review label changes in collaboration with affiliates and regulatory teams; provide medical input to regulatory scientists; assist with regulatory submissions and reports from a global perspective; participate in advisory committees; contribute to risk management planning with GPS.
• Business/Customer Support (Pre- and Post-Launch): Contribute to medical strategies to support brand commercialization; anticipate and address scientific information needs of payers, patients, and healthcare providers; lead data analyses and research to support payer partnerships and product value; collaborate with marketing and other teams; help define the Patient Journey and Moments of Truth; engage with trade associations as appropriate; contribute to development and approval of promotional materials as needed.
• Scientific/Technical Expertise and Continued Development: Critically evaluate medical literature; stay informed on product-related clinical trends; provide scientific training to the study team; act as a protocol expert and scientific consultant; pursue extramural scientific opportunities; attend scientific symposia.
• General Responsibilities: Support development of the business unit budget; pursue professional development and mentoring; participate in recruitment and diversity efforts; collaborate with alliance, business, and vendor partners; provide constructive feedback and participate in committees and Six Sigma initiatives; maintain qualification and training maps; model leadership and act as an ambassador for patients and Lilly.

Qualifications

• Required: Medical Doctor or Doctor of Osteopathy; board eligibility or certification in an appropriate specialty/subspecialty; US-trained physicians must have board eligibility or certification; non-US physicians must be LCME-qualified for education/training; ability to work in a global, regulated environment with knowledge of GCPs and relevant regulations.
• Preferred: Demonstrated ability to balance scientific priorities with business priorities and lead teams; strong communication, interpersonal, teamwork, organizational, and negotiation skills; ability to influence across functions; willingness to travel domestically and internationally as needed; fluent English (written and spoken).

Education

• Medical Doctor or Doctor of Osteopathy. Board eligibility or certification required (U.S. context). Non-U.S. trained physicians must have completed education/training meeting LCME requirements.