Immunomedics, Inc.

  • Program Manager, Clinical Research

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(3 months ago)
    Job ID
    2018-1081
    # of Openings
    1
    Category
    Clinical
  • Overview

    The Program Manager, Clinical Research will be responsible for overseeing the planning, implementation, and tracking of projects.  This individual will also report metrics, risks, and mitigation plans to Senior Management.

    Responsibilities

    • Provides overall portfolio oversight and ensures senior management is updated on metrics, risks, and mitigation plans.
    • Oversees the process for new product planning and will be responsible for development and maintenance of launch roadmaps.
    • Directs initial stages of the project by establishing scope, budget, and timelines.
    • Creates required project plans. Per SOP’s, implements and monitors progress against project plans and revises as necessary.
    • Provides project-focused leadership and will be responsible for managing a team.
    • Builds close relationships with launch team and other cross-functional teams to confirm alignment with overall strategy to successfully obtain product approval.
    • Aligns company goals with project strategy and tactical execution leveraging constant transparent communication with various stakeholders.
    • Develops and maintains collaborations with CROs and other external vendors.
    • Collaborates internally with Clinical Operations leads and study managers to initiate RFPs.
    • Leads implementation of process improvement initiatives on projects as requested. Meets financial performance targets and is accountable for budget controls across assigned projects.
    • Ensures effective cross-functional collaboration with team of peers and functional leaders in various departments to collaboratively develop support for implementation of portfolio decisions, monitor performance, and respond to deficiencies with corrective actions.
    • Chairs the PM team meetings. Responsible for developing meeting agendas and distributing meeting minutes.
    • Ensures that Executive Director Clinical Operations and the Chief Medical Officer are updated about any critical issues impacting project timelines, risks, resource allocations, quality, and budget.

    It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.

    Qualifications

    • Experience with all phases of clinical trials, particularly large multi-center and/or global trials, including investigational site management, data collection, and study protocol compliance.
    • Knowledge of GCPs and regulatory requirements. Experience in clinical data interpretation and verification.
    • Expertise in building/optimizing organizational processes, measurement systems, and infrastructure to maximize results in product launches and portfolio maximization.
    • Proficiency in Excel and Microsoft Project.
    • Strong problem solving and critical thinking skills.
    • Strong organizational Skills and attention to detail
    • Bachelor’s degree in a health related discipline with minimum 10+ years of relevant experience in pharmaceutical/biotechnology, in Project Management/program management, vendor management.
    • Environment: Standard office setting; exposure to computer screens.
    • Physical: Primary functions require sufficient physical ability to work in an office setting and operate standard office equipment including use of a computer keyboard.  Sedentary work, which includes exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to move objects.  Involves sitting most of the time, but may include walking or standing for brief periods of time. 
    • Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
    • Hearing: Hear in the normal audio range with or without correction.
    • Travel: Ability to travel overnight 10% or more as needed.

     

     

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