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.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

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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 including, but not limited to document review of packaging specifications, master, and executed batch records, distribution instructions and order processing and delivery.

• Provide on-going monitoring of inventory and expiration dates for assigned program/study. Ensures alignment with supply forecast and study/program requirements.

• Manage global accountability tracking including destruction for assigned programs.

• Support clinical label development including generation of master label text, translations, leading to a label proof.

• Review and provide input to documents including, but not limited to pharmacy manuals, IMPDs, request for proposals, and IRT/IWRS specifications.

• Participate on project teams and sub-teams as needed and assigned.

• Track progress versus timelines and goals.

• Ensure documents and records are maintained in compliance with regulations and SOPs including the Trial Master File (TMF).

• Continuously assess business processes for inefficiencies and improvement opportunities, identify action plans, and implement improvements. Network with clinical partners to ensure efficient cross-functional processes. Identify capability gaps at existing Contract Manufacturing Organizations (CMOs) identify CMOs with the needed capabilities.

• Qualifications and Background Required:

• BA/BS and a minimum of 3-5 years of broad experience working in a Biotech or Pharmaceutical FDA regulated industry in Clinical Supply Management or a related field or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.

• Solid understanding of pharmaceutical development, manufacturing, packaging, labeling and global distribution.

• Eager to communicate and collaborate with team members across functions including but not limited to clinical operations, CMC, regulatory affairs, and QA.

• Working knowledge of cGMP’s (CFR/ICH) and GCP and appl