Associate Director, Clinical Supply Management

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 to those who need them, 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.

About Loxo@Lilly:

Loxo@Lilly (L@L) conducts discovery research, clinical development, and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. L@L was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Position Summary:

The Associate Director, Clinical Supply Management has responsibility for the end to end strategy, specifications, on-time delivery, and management of the clinical trial material supply for the entire study life cycle for a portfolio of oncology compounds associated studies, clinical sites, and contract manufacturing and distribution organizations.

Roles and Responsibilities of the Position*:

• Support Clinical Supply Management by contributing to drug development work streams with internal and external team members to ensure robust supply chain strategies for the on-time delivery of clinical supplies across the oncology portfolio.
• Communicate with CMC and clinical partners to outline potential risks, limitations, and mitigation strategies (where appropriate) associated with the CT material supply for each compound and study supported.
• Develop compound and study level supply plans and manufacturing and packaging schedules. Identify and account for demand uncertainty and ensure on time availability of study drug.
• Advise the CMC team and clinical partners on strategic options for combination drug sourcing, packaging and label design and standardization, distribution, use of Interactive Response Systems (IRT/IWRS), material pooling, retest dating management, and inventory/resupply management.
• Contribute to the development of clinical protocols which account for CT material supply limitations and risks and allow ease of use and compliance by subjects/patients and clinical site staff. Update and maintain study supply plans including drug supply forecasts for manufacturing, packaging, and labeling operations.
• Provide technical oversight of packaging and distribution collaboration partners …