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Senior manager, clinical drug supply

Amplyx Pharmaceuticals, Inc

This is a Full-time position in San Diego, CA posted December 20, 2019.

Senior Manager, Clinical Drug SupplyAmplyx is recruiting a Senior Manager, Clinical Drug Supply to play a key role in the forecasting, packaging, labelling, release, tracking inventory and distribution of clinical trial materials (CTM) for global clinical studies.

The Candidate will work collaboratively with other members of the CMC team, and with functional areas including Quality, Clinical Operations, Regulatory and Project Management to meet project deliverables.Key Responsibilities include but are not limited to: Possess a demonstrated knowledge of CTM planning, manufacturing, packaging, and labeling, overall study supply management, as well as knowledge of GMP, GCP and applicable regulatory guidance.Works with clinical operations and cross-functional project teams to define, recommend and implement labeling and packaging options to best support the specific clinical study and comply with applicable regulatory guidelines.

* Leads the CTM vendor selection process, manages the preparation of RFPs, assumptions, and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); * Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan; * Oversees investigational product (IP) shipment orders according to supply plans or as requested by Clinical Operations, to ensure timely and compliant shipment and delivery to clinical supply depots and / or investigative sites.

Works with Clinical Operations on the setup and management of IVRS (IWRS) * Manages and tracks IP inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends.

* Sourcing of comparators and matching placebo as required on a project by project basis.Works closely with Manufacturing vendors, CMC and Quality to process and approve GMP documents in compliance with regulatory requirements and internal SOPs.Provides input into the development of Investigational Product-related study documents including protocols, study and pharmacy manuals; and supports regulatory filings including IND submission information, regulatory audits and information to support regulatory audits.Constructs and manages clinical supply budget, reviews and approves specified costs on vendor invoices; Provides input into budgets, SOWs, contracts and timelines for clinical supply-related servicesRepresents Clinical Supply Management on cross-functional study team (s) and/or sub-team(s)Develops, manages, and maintains relationships with external partners; effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful executionExperience and Education: Bachelor’s degree and at least 3 years of relevant experience in the biotechnology/pharmaceutical industry, with 2 years minimum in CTM management. High level of understanding of Global Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international), as well as experience with quality management systems, clinical supply methodology and SOP’s, and GMP documentation including batch records, deviation reports, change control is required.Excellent verbal, written, and social communication skills are required.Strong computer and organizational skills required.Experience in Project Management, CTM Management, and/or Pharmaceutical Development required