• Clinical Supply Manager

    Job Locations US-PA-Exton
    Posted Date 3 weeks ago(5/4/2018 1:49 PM)
    Job ID
    2018-1073
    # of Openings
    1
    Category
    Development
  • Overview

    The Clinical Supply Manager is a key member of the clinical study team responsible for ensuring the timely provision of investigational and pre-commercial product for Idera’s clinical trials. This role collaborates and coordinates with CMC, the clinical study team, regulatory, QA, and others applicable in creating supply plans, and works with outsource vendors to ensure labeling, packaging, and shipping of clinical trial material in compliance with applicable regulations and program timelines.

    Responsibilities

    Inventory management: Ensure uninterrupted supplies throughout the duration of clinical studies. 

    • Manage the logistic activities of the clinical supply chain including initiating and managing all GMP bulk shipments for API and finished product
    • Develop and monitor demand forecast for clinical trial needs.  Maintain/ track inventory and expiration dates,
    • Manage drug shipments from manufacture site to storage/distribution site
    • Provide and/or support documentation for global shipment of clinical supplies, e.g., proformas and commercial invoice
    • Utilize IXRS to assist in the management of inventory at depots and sites and ensure on-time delivery with minimal overage of clinical supplies.

    Vendor management: Be the single point of contact for a robust and appropriate clinical supply chain vendor network.

    • Manage the identification and selection/contracting of qualified, cost-effective vendors in conjunction with applicable functions for the management, execution and distribution of CTM, clinical supplies and IXRS.
    • Develop detailed Requests for Information (RFI), Requests for Proposals (RFP), and Statements of Work (SOW)  
    • Manage the clinical supply budget, vendor receiving/invoicing, contracts, performance against SOWs, and pricing for CTM distribution.

    Cross-Functional Teamwork: Act as Supply Chain representative on cross-functional clinical teams

    • Collaborate with Clinical Operations, clinical packaging sites, CROs, and others as applicable to manage all clinical supply-related activities across projects / products.
    • Conduct issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution).
    • Collaborate with Clinical Operations, labeling/packaging CROs, QA and regulatory agencies to develop regulatory compliant label design and printing for finished product.
    • Participate and present at Investigator Meetings, as required.

    Qualifications

    Key Attributes

    • Highly-motivated and personally accountable self-starter who works with a sense of urgency.
    • Strong project management and problem-solving skills
    • A good teammate who is easily able to work constructively in a team environment. 
    • Committed to quality
    • Ability to balance multiple projects with appropriate prioritization
    • Demonstrated ability to collaborate with other functional areas such as Development, Clinical Operations, Regulatory, and Quality Assurance.
    • Knowledge of Interactive Voice/Web response systems for use in clinical studies
    • Working knowledge of regulations relating to clinical labeling, packaging and distribution activities (cGMP, GCP).

    Education & Experience Requirements

    • Bachelor’s degree with 5-7 years relevant experience working in a Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in the Biotech or Pharmaceutical Industry.
    • Meaningful experience managing outsourced resources. Direct Clinical Supply management experience using contract manufacturing companies strongly preferred.

    Other Job Requirements 

    • Some travel required, est. up to 20%.

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