The Senior Manager, Clinical Supply will lead and work independently to manage all clinical supply activities for multiple clinical studies supplied globally (Phase 1 to 3). To maintain supply continuity, the candidate will work and contribute as part of a cross functional team to execute supply strategy with internal and external customers as required.
- Develops and forecasts IMP for on-going and new and clinical trials. Collaborates, prioritizes, and leads activity for contract manufacturing organizations to support the labeling, packaging, and distribution of clinical products across multiple clinical studies.
- Responsible for drug supply related modules in Interactive Response Technology (IRT) systems. May initiate/review system user requirements, implementation timelines, perform User Acceptance Testing, submit Data Control Requests, review reports and ensure on-going execution of drug distribution, return logistics, destruction, and inventory reconciliation activities in the IRT.
- Lead the development of inventory forecasts, demand and productions plans.
- Track clinical supplies inventory consumption and expiration to ensure drug and supplies are available based on forecasted and actual demands.
- Strong understanding of IMP blinding and able to interpret protocols design and coming up with a drug blinding strategy for the team. May initiate the development of clinical label text for study drug. Coordinate the review and approval of label text and proofs.
- Collaborates with QA and regulatory teams to support the release of clinical supply material and to provide documentation required for regulatory review and submissions.
- Represent the Clinical Supply function for Clinical study related meetings to stay informed of clinical study/site level status and supply needs for forecasting and planning purposes.
- Ensure readiness for regulatory inspections and/or internal audits as required. May represent the Clinical Supply function during inspections.
- Collaborates with the Sr. Director and vendors to develop supply budget forecasts and track actual monthly spends and overall management of quotes as required.
- Develops SOPs, Work Practices, and guidance documents for GMP related activity.
- Partners with QA to initiate, document, and close out investigations, deviations, and CAPAs as required.
- Acts as main point of contact with contract manufacturing organizations for clinical supply related activities.
- Participate in Business review meetings with CMOs.
- Able to facilitate and provide guidance for Trial Master File set up and providing consistent archival activities as required.
- Leverage knowledge on sourcing commercial comparators required for clinical trial use.
- Leveraging experience in ensuring EU/UK QP releases while partnering with Quality and Regulatory on necessary filing updates.
- Bachelor’s degree in a technical or scientific discipline is preferred.
- 5 to 10 years of relevant supply chain experience in the bio-pharmaceutical industry including supply planning, CMO oversight, and labeling and packaging and budget oversight
- Experience in Clinical Supplies Manufacturing and/or Quality is a plus
- Proven track record of ensuring study deliverables met and of contributing to cross-functional teams.
- Strong communication, interpersonal/team skills, and demonstrated strategic planning capabilities.
- Must have advanced ability to prioritize and manage multiple tasks simultaneously, identify and resolve issues collaboratively, and effectively manage timelines