Sr. Director - Clinical Development

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

This SR. Director role within the Immunology gastroenterology therapeutic area will support early and late phase clinical trials for assets in the gastroenterology pipeline. The Clinical Development Director participates in the development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety;

the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, and documents supporting product pricing, reimbursement, and access (PRA); grant submissions; outreach medical activities with external clinical communities; and the development and implementation of the business unit and global strategy for the product. The role also participates in medical activities in support of demand realization, regulatory interactions, and business‑to‑business and business‑to‑government activities.

Clinical Planning

• Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology to develop and maintain a Draft Launch Label and Value Proposition that addresses key customer needs.
• Contribute to business unit and global alignment of clinical strategy and clinical plans.
• Understand and keep updated with the pre‑clinical and clinical data relevant to the molecule.

Clinical Research / Trial / Execution and Support

• Plan, collaborate on and review scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions according to the agreed upon project timeline.
• Provide protocol oversight and input into informed consent documents.
• Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials.
• Review and approve risk profiles to ensure appropriate communication of risk to study subjects.
• Participate in investigator identification and selection.
• Ensure operational team documents completion of administrative requirements for study initiation and conduct.
• Assist in planning process and participate in study start‑up meetings.
• Serve as resource to clinical operations and monitors to address questions or clarify issues during the conduct of study.
• Monitor patient safety and track adverse events in alignment with corporate patient safety policies.

Scientific Data Dissemination / Exchange

• Maintain compliance with regulations and policies on data dissemination.
• Address scientific information needs of external healthcare professionals.
• Participate in reporting of clinical trial data on Clinical Trial Registry.
• Support planning of symposia, advisory board meetings, and other conferences.
• Support medical information associates and prepare scientific information for customer questions or media requests.
• Support data analysis and development of slide sets and publications.
• Establish and maintain collaborations with external experts, thought leaders, and the medical community.

Regulatory Support Activities

• Participate in development and review of label changes and labeling modifications.
• Provide medical expertise to regulatory…