- Serve as the primary clinical supply chain contact, working collaboratively with internal stakeholders (ie. TMO, Clinical Operations, etc.) and external partners
- Manage clinical supply planning and forecasting for study protocols
- Support financial planning for global clinical supplies (including budgeting, forecasting, and strategic planning activities for clinical trials)
- Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategies
- Monitor global clinical supply inventory at the clinical site level for both IVRS and studies by tracking of specific milestone dates and adjusting drug distribution accordingly
- Coordinate the origination, proofing and translation of clinical study labels, as required
- Coordinate drug supply delivery timelines with Clinical, packaging suppliers, drug depots, etc.
- Maintain close communication with team members (ie. SC, clinical, regulatory) to ensure the adequate supply of clinical supplies throughout the duration of all clinical trials
- Serve as 'consultant' for Zymeworks and its partners related to managing clinical supplies
- Serve as member of clinical study team by participating in the design of study plans, protocols, IB's, etc.
- Monitor IXRS portal processes including high and low enrolling site settings, drug acknowledgement, depot and site supply levels, and IMP status of released lots or expired drug
- Recommend appropriate method of packaging, labeling, and distribution
- Manage third party packaging/labeling, and logistics suppliers
- Provide reports on available inventory, and updates expiry date/shelf life extensions at the depot
- Procure ancillary supplies with attention to local sourcing vs bulk sourcing strategies, lead-time, and expiry dating
- Coordinate the assessment of temperature excursions during storage, receipt, or transit to study sites or depots
- Facilitates the development, negotiation, and approval of formal quotations and proposals; work orders; purchase orders; etc.
- Monitors the performance of service providers to ensure efficient, high quality, cost effective execution of outsourced investigational supply activities
- Proactively coordinates with mfg, clinical, regulatory and QA departments to establish appropriate production plans and timing for P&L based on fill/finish release dates, regulatory requirements and the drug demand forecast
- Coordinates timely material release with Regulatory and QA functions
- Provides knowledge in IOR responsibilities, brokerage selection, strategic ship dates and lead time for each global shipping lane
- Liaises with brokers and customs officers to facilitate clearance, to avoid any shipping delay.
- Analyzes and interprets US and foreign countries' import and export regulations to facilitate compliance efforts by applying for and coordinating import permits and export permits
- Designs labels to ensure regulatory compliance with US, Canada, EU, APAC regulations, as appropriate. Works with Clinical, Regulatory, QA, and Manufacturing to develop Master Label text and arrange translation services as required
- Establishes appropriate packaging and labeling schedules, including appropriate contingency plans to support unanticipated demand shifts and potential supply shortages
- Coordinates with QA on the review and approval of all documentation associated with labeling of investigational supplies (e.g., label proofs, packaging and labeling specifications and methods, packaging batch records)
- 8+ years' related clinical supply management experience in cGMP and GCP Ph I-III studies (Supply Chain Management Association accreditation as a Supply Chain Management Professional (SCMP) a plus)
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
- Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment
- Experience setting up and managing distribution protocols for PHI-III clinical studies, under IXRS or manual request strategies
- Practical experience with Annex 13 (EU), Annex 2 (Canada), FDA CFR 21 drug labeling guidelines, drug pooling strategies, JIT labeling, and review of packaging and labeling batch records
- Ability to design a multi-country investigational drug label under regulatory guidelines for each country (EU, APAC, USA, CAN). Proven experience in translating the master label into a multi-language booklet label
- Proficient in forecasting strategies and software tools to develop a clinical forecast based on a clinical protocol. Ability to translate the forecast for distribution, Manufacturing and Clinical teams
- Experience working closely with Compliance, QA, Regulatory, Manufacturing, Clinical and Finance in a GMP environment
- Knowledge of import and export of biologics from customs document creation (USDA, End Use, Customs Invoice), to import/export regulations (CRA, FDA CFR 21, CIQ (China Inspection and Quarantine), to brokerage set up (POA) and IOR responsibility
- Ability to interpret a clinical protocol for clinical supplies forecasting and procurement needs
- Proficient in depot protocol set up for cGMP storage and distribution of investigational drug product
- Demonstrated experience with global clinical supply forecasting, planning, manufacturing, packaging, and labeling; inventory management; IXRS systems; 3rd Party service providers (clinical packaging/labeling); and budgetary forecasting/management
- Strong knowledge of cGMPs and GCPs and global Health Authority requirements as related to investigational supplies. Familiarity with various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.)
- Excellent communication skills (both written and oral) are essential as are negotiating, influencing, and project management skills
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Description
Work Requirement
This role will be based out of our Bellevue, WA office and is hybrid with a minimum of 3 days per week onsite.
Key Responsibilities
Education and Experience
Skills and Abilities:
