Immunomedics, Inc.

  • Senior Medical Director, Safety and Pharmacovigilance

    Job Locations US-NJ-Morris Plains
    Posted Date 1 week ago(1/14/2019 3:10 PM)
    Job ID
    2019-1390
    # of Openings
    1
    Category
    Other
  • Overview

    Reporting to the Vice President, Global Head of Safety and Pharmacovigilance, the Senior Medical Director will be responsible for the oversight of all medical safety functions for Immunomedics’ products, both those in clinical development and marketed products.  This global role involves both strategic and operational aspects. The Senior Medical Director will be responsible for the ongoing safety surveillance of Immunomedics’ products, including evaluation of safety data from all sources, signal detection, benefit-risk evaluation, and, development and implementation of risk management strategies, and will lead cross-functional Safety Management Teams.  Additional responsibilities include oversight of medical safety functions performed by vendors, such as medical review of individual case safety reports, and oversight/authoring of safety sections of regulatory submissions, including periodic reports and marketing authorization applications.  This role will involve close collaboration with the Clinical Development teams, Regulatory Affairs, Medical Affairs, and Clinical Quality Assurance functions, and the Senior Director, Safety and Pharmacovigilance.  The Senior Medical Director will be the Subject Matter Expert for safety and pharmacovigilance issues related to Immunomedics’ products, other related products (both in development and marketed), and the indications under study.  Importantly, the Senior Medical Director will aid the Global Head in strategic planning for creating and implementing state-of-the-art processes for safety surveillance, signal detection, benefit-risk evaluations, and risk management activities, and developing an organizational structure to support these activities.

    Responsibilities

    • Lead and perform safety surveillance for Immunomedics’ investigational and marketed products, including evaluation of emerging safety data from all sources (clinical trial, post-marketing, literature, and, as applicable, nonclinical) in order to perform signal detection, benefit-risk evaluation, and identifying the need for risk management activities
    • Perform health hazard evaluations for product quality issues
    • Lead cross-functional Safety Management Teams, including presentation of results and interpretation of safety data, evaluation of potential signals, and, as needed, escalation to senior/executive management
    • Based on results of safety surveillance activities and in collaboration with the members of the Safety Management Team identify the need for updates to the Investigator’s Brochures, Company Core Data Sheets, and local product labels; prepare documentation to support updates
    • Provide safety/pharmacovigilance strategic input to Clinical Development, Medical Affairs, and Regulatory Affairs for clinical development programs, including new indications for lead compound, collection of safety data in clinical trials, and strategic approaches for analyses of safety data to be included in planned marketing authorization applications
    • Oversee medical safety functions performed by vendors, such as medical review of individual case safety reports
    • Act as medical safety lead for collaborations with license partners and for investigator-initiated trials; lead joint safety teams with partners
    • Evaluate aggregate safety data and oversee preparation/author safety sections of regulatory submissions, including periodic reports, Investigator’s Brochures, marketing authorization applications (Summaries of Clinical Safety, Clinical Overviews), Risk Management Plans, and ad hoc health authority requests regarding safety issues
    • Ensure consistent communication and documentation of safety data across various documents, such as Investigator’s Brochures, clinical trial protocols, and other regulatory submissions
    • Act as Subject Matter Expert for safety and pharmacovigilance issues related to Immunomedics’ products, other related products (both in development and marketed), and the indications under study
    • Conduct product training for vendors and investigators
    • Support the Global Head, Safety and Pharmacovigilance and Senior Director during health authority inspections, including preparation of medical safety documentation, and follow-up activities such as responses and CAPA development and implementation
    • Participate in short-term and long-term strategic planning for the development of the Safety and Pharmacovigilance Department, including procedures for creating and implementing state-of-the-art processes for safety surveillance, signal detection, benefit-risk evaluations, and risk management activities, developing an organizational structure to support these activities, and transitioning from a fully-outsourced model to an organization with internal capabilities
    • Identify the need for process improvements, development of metrics related to medical safety functions
    • In collaboration with the Senior Director, Safety and Pharmacovigilance, author/review SOPs that relate to medical safety and pharmacovigilance functions

    Qualifications

    • MD degree with at least 10 years of global pharmacovigilance and drug safety and management experience; subspecialty training desired
    • Expert knowledge of global safety regulations, including FDA, EU GVP, ICH guidelines, and other applicable global safety regulations and guidance
    • Expert in clinical safety assessments, signal detection and risk management, for safety issues that arise during clinical development, as well as post-marketing
    • Experience in pharmacovigilance inspections
    • Prior experience in planning and preparation of marketing authorization applications desirable
    • Ability to work in a “start-up” environment, which is fast-paced, dynamic, and evolving from a research-based organization into a commercial organization
    • Ability to work both independently and collaboratively with internal stakeholders
    • Outstanding leadership skills including the ability to drive and support a culture of high quality and scientific standards, ethics and integrity
    • Excellent communication (verbal and written), analytical, problem-solving, and decision-making skills

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