Karyopharm Therapeutics Inc.

  • Associate Director, Clinical Supply Chain

    Job Locations US-MA-Newton
    Job ID
    2018-1241
    # of Openings
    1
    Category
    Research and Development
    Type
    Regular Full-Time
  • Overview

    Karyopharm  Therapeutics  is  a  clinical-stage  pharmaceutical  company   focused   on   the   discovery and  development  of  novel  first   in-class   drugs   directed   against   nuclear   transport   targets   for   the treatment of cancer and other major diseases.

     

    The role will have responsibility for executing and refining organizational strategies for multiple Clinical Trial Materials (CTM) and the necessary management competencies, to ensure of a continuous product supply for drug products (IMP) in support of clinical trials worldwide. CTM Management competencies include Forecasting and Planning, Packaging and Labeling, Global Distribution, IRT Technology, Outsourcing Management, Capacity and Performance Metrics, Project Management, and Conformance of Quality and Compliance requirements.

    Responsibilities

    • Coordinate internal teams responsible for US and international clinical distribution with CMOs
    • Develop and implement CTM supply plans, integrated with clinical trial timelines, including assignment of resources, for sponsored and IST clinical trials. Oversee the creation and review the clinical supply and demand forecasts based on strategic elements/study forecasts from Clinical Operations for studies and/or programs
    • Aggregate and quantify future requirements for clinical trial materials into a comprehensive supply/demand forecast, ensuring a supply chain capable of supporting multiple complex phase III
    • Identify the most suitable CRO/CMO and initiate contracts. Oversee work assignment and deliverables for CTM suppliers, and collaborate on and review of pre- and post-executed batch records to ensure timely completion of CTM milestones and internal development work.
    • Oversee the distribution/logistics activities of complex supply chains by evaluating supply strategies, tracking inventories, tracking expiry dates, initiating bulk shipments, and coordinating import/export requirements to minimize time to drug availability at sites
    • Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered
    • Oversee global label development strategies and packaging timelines
    • Oversee IRT selection and implementation, including development of internal User Acceptance Testing plans which augment and operate in conjunction with the vendor UAT to ensure the IRT is in line with clinical trial needs
    • Develop and maintain companywide metrics for clinical supply. Identify gaps in departmental procedures, and design and implement gap solutions
    • Develop and implement harmonized best practice policy and operational procedures that are in- line with the integration of Clinical Operations and CTM supply needs of managed clinical studies.
    • Build new or advanced expertise to match up with CTM supply needs driven by the clinical program dynamics, new therapeutical area(s) and product development
    • Manage operating budgets for outsourced services and activities. Lead initiatives for generation, refinement and maintenance of clinical supply infrastructure and cross- functional
    • Ensure department compliance with ICH, Federal U.S. and any pertinent local regulations and adhere to internal SOP and Guidance

    Qualifications

    • Bachelor’s degree in life sciences or business major with 10+ years of clinical supply management experience in the pharmaceutical field or an MS degree with 8+ years of experience
    • Relevant experience will include: selection/implementation and management of IRT systems, label design, labeling and packaging operations, supply chain CMO management and distribution in North America and Europe.
    • A thorough understanding of the clinical trial process and clinical trial supply chains
    • Knowledge of cGMPs and relevant FDA and EU Regulations
    • Familiarity with US and EU regulatory agencies and their guidance as they pertain to clinical supplies
    • Effective communication (oral and written) internally and externally with vendors and partners
    • Ability to multi-task and work in a fast paced and dynamic environment
    • Strong working knowledge of standard business software, including MS Excel, Word, PowerPoint and Project
    • Strong analytical and/or organizational skills

     

    Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer.  All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.  Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities.  If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department. 

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