Karyopharm Therapeutics Inc.

  • IT Business Partner, Regulated Systems

    Job Locations US-MA-Newton
    Job ID
    2018-1069
    # of Openings
    1
    Category
    General & Administrative
    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.

     

    Responsibilities

    We are looking for an IT Business Partner that will work with the Senior Director, Enterprise Applications in providing oversight of the design, definition, implementation, testing, integration, and support/operations of the regulated systems. This individual will support the Regulatory, Quality, Clinical, and Pharmacovigilance groups to analyze the existing enterprise applications portfolio and provide support of the roadmap for that portfolio of applications and assist in defining opportunities for change.

     

    • Ownership of the technology portfolio related Regulatory, Quality, Clinical, and Pharmacovigilance, ensuring interoperability and responsiveness to the technology needs of these groups
    • Assist the Senior Director in ensuring that the application architectures are understood, properly implemented, and administered effectively
    • Establish and maintain positive relationships with strategic development partners and with internal business partners
    • Manage vendor relationships for application components of the architecture
    • Oversee monitoring of all relational database implementations in conjunction with the infrastructure team to ensure proper security, efficient utilization, allocation and user access
    • Stay abreast of IT best practices around pharmaceutical and other industry technologies and their relevance to the company
    • Assist the Senior Director in the development of statements of work, contracts, managed service and service level agreements with vendors, and strategic sourcing related to the area of focus
    • Assist in the writing and management of controlled processes around systems including validation, change control, electronic signature, and system-specific sysadmin documentation
    • Develop and disseminate application training materials and support standards for the user community supported
    • Oversee application development, implementation, and configuration through a structured project lifecycle methodology to successfully deliver internally developed, purchased/customized, and SaaS solutions related
    • Establishing and developing strong relationships with function leaders to understand strategy and execution plans

    Qualifications

    • Minimum 5 years’ technical experience with demonstrated success leading pharmaceutical regulated system projects and upgrades
    • Demonstrated technical leadership experience, which has included the successful development and implementation of roadmaps for large, multiple location, enterprise-wide application initiatives
    • Understanding of the pharmaceutical industry and its application environment needs within the   clinical, pharmacovigilance, quality and regulatory functions. Solid knowledge of Veeva Vault and Argus software packages, with the completion of at least one implementation/upgrade as project leader or active participant
    • Strong understanding of the relationship between applications, databases, operating systems, processing platforms, storage platforms, and networks
    • Experience in complete life cycle management including but is not limited to: requirements gathering and documentation methodologies, application design, vendor selection, development methodologies and project tracking, source control and defect tracking, change management, release control, and documentation, deployment and training
    • A forward-looking, run to the work, solution seeking mindset
    • Analytical skills and ability to link work priorities to business imperatives
    • Excellent communication and influencing skills, with demonstrated ability to work collaboratively and effectively across the organization
    • Proven ability to manage third-party relationships in the management of hosted/SaaS systems
    • Working knowledge of the processes associated with the Regulatory, Quality, Clinical, and Pharmacovigilance functions
    • Experience in a planning and control role (budget tracking, plan development, status reporting, etc.)
    • Knowledge of GxP, as it applies to computer systems, and validation requirements is highly desired
    • Team leader with an ability to set specific measurable milestones and monitoring progress against these goals
    • Bachelor’s degree or equivalent required

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