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 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 applicable international regulations/guidelines.
• Working knowledge of QP requirements, and import/export regulations.
• Ability to think broadly and apply knowledge and experience to complex supply planning situations.
• Ability to develop and maintain detailed supply plans through continual assessment of supply and enrollment using various tools, including Microsoft Excel.
• Prefer experience working with third-party vendors and contractors,
• Global experience with phase 1-4 clinical trials.
• Experience writing and presenting clearly on clinical supply topics.
• Ability to work in a virtual environment.

Lilly (Eli Lilly and Company) currently anticipates that the base salary for this position could range from between $111,000-162,800 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo@Lilly (Eli Lilly and Company) offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo@Lilly (Eli Lilly and Company) reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Loxo@Lilly (Eli Lilly and Company) compensation practices and guidelines will apply regarding the details of any promotion or transfer of Loxo@Lilly (Eli Lilly and Company) employees.

Physical Demands:

The physical demands of this position are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is based in a typical office setting.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly