Associate Director

1 week ago

Washington, United States Mantell Associates Full time


Mantell Associates is partnered with a publicly listed, clinical-stage biopharmaceutical company, who are searching for an Associate Director for their Clinical Supply Chain.


Associate Director - Responsibilities:
Serve as the primary clinical supply chain contact, working collaboratively with internal stakeholders 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 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 to ensure the adequate supply of clinical supplies throughout the duraction of all clinical trials
Serve as member of clinical study team by participating in the design of study plans, protocols, IB's, etc.
Monitor 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)

Associate Director - Requirements :
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

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at

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