$80K — $100K *
The Senior Manager, Clinical Supply Chain will manage clinical supply activities for multiple investigational studies supplied globally. To maintain supply chain continuity, the candidate will work and facilitate as part of a cross functional team to develop and execute supply strategy with internal and external customers as required.
Leads, facilitates and contributes and manages all aspects of clinical supply planning, capacity planning, labeling/packaging production strategy and execution, and risk management for clinical study related products
Leads, facilitates and contributes and manages and actively manages relationships with labeling/packaging/distribution Contract Manufacturing Organizations to ensure production and inventory targets are communicated and met
Assists with the Clinical Supply Chain Lead on study budget management and forecast, developing and maintaining Request for Proposals/Change Orders (RFPs/COs) and initiates contract requests and is accountable for invoice review and approvals, financial tracking and reconciliation of project costs.
Assist Clinical Supply Chain Lead in department led initiatives as required
Assist Clinical Supply Chain Lead in writing SOPs or work procedures as required.
Participates in CMC team meetings and collaborates with CMC Team Leaders to ensure Drug Substance and Drug Product availability and provides forecast IP for inventory maintenance as required.
Collaborates with Analytical Stability and Quality to ensure expiration extension dating and communicating the need of expiry date for planned labeling and packaging activities as required.
Consults, advises and leads the clinical team on proper blinding methods for all IP activities for a blinded clinical trial based on cross-functional input from CMC and quality as required.
Responsible for sourcing commercial comparator product as required per study need.
Provides input and information for clinical protocols and regulatory dossiers as required
Actively communicates, collaborates with and contributes to other functional areas including Clinical Operations, Quality Assurance, CMC, and external partners and drives to achieve the best development and business results for the company
Leads, facilitates and manages Demand/Supply Monthly Project team meetings that incorporates cross-functional discussions with inputs from Clinical Operations, Supply Chain, Analytical Stability, Regulatory, Quality, CMC and other ad hoc members as required
Participates in the Clinical Supply Chain team and supports Commercial Supply Chain activities, as required
Bachelor’s degree in a technical or scientific discipline
5 + years of relevant supply chain experience in the bio-pharmaceutical industry including supply planning, CMO oversight, and labeling and packaging
Experience in Clinical Manufacturing Operations
Solid experience in GMP operations and a proven track record of study deliverables and contributing to cross-functional teams
Strong communication, interpersonal/team skills, and demonstrated strategic planning capabilities
Ability to prioritize and manage multiple tasks simultaneously, to identify and resolve issues, and effectively manage timelines
Valid through: 3/18/2021