Manager, Supply Chain Operations
- Work cross functionally with Clinical Operations, CMC, Quality Assurance, and Regulatory Affairsto ensure uninterrupted and compliant supply of Investigational Product (IP) for assigned clinical studies and Investigator Initiated Trials
- Work with Clinical Operations and CMC to define supply strategies for clinical study IP as well as IP to support Investigator Initiated Trials and other collaborative studies in line with the study protocols
- Draft and actively manage a supply forecast while monitoring the projections vs patient enrollment vs inventory
- Work closely with Clinical Operations to develop clinical supply packaging and label design to coincide with the protocol(s), regulatory requirements, blinding/randomization concerns and ease of handling by the sites/patients
- Ensure accurate demand signals and inventory levels are incorporated into the overall supply plan for manufacture of API and IP
- Identify and manage CMO’s for the support of Clinical Supply Distribution (including but not limited to):
- Draft Request for Proposals (RFP)
- Negotiate contracts and budgets
- Develop and manage the planning, scheduling, and coordination of the packaging and labeling projects to ensure the availability and timely delivery of clinical supplies
- Develop and manage reconciliation process for each study
- Review invoices for approval
- Support Clinical Operations in contract negotiation, development and ongoing maintenance of interactive response technology (IRT) and other systems used for the management of IP in clinical studies.
- Assist Quality Assurance in management of IP stability programs and retest date extensions
- Assist with in-house drug product development, testing and preparation in support of preclinical studies
- Assist with drug product analytical methods development
- Assist in oversight of IP contract manufacturers
- Thorough understanding of regulatory requirements for clinical supply distribution in US and EU including testing and labeling. Knowledge of Latin American requirements helpful. Thorough understanding of GMP, GCP, and national/international transportation requirements for pharmaceutical materials
- Knowledge and understanding of Supply Chain principles; Certified Professional in Supply Management (CPSM) certification desirable but not essential.
- Knowledge and understanding of small molecule analytical methods development, analytical method transfer to CMOs, analytical methods qualification/validation, and drug product stability study planning/oversight a plus
- Strong organizational, analytical and interpersonal skills.
Ability to work in a fast paced, dynamic environment with multiple projects. This position is Exempt.