Immunomedics, Inc.

  • Director / Senior Medical Director, Clinical Development

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(7/11/2019 10:42 PM)
    Job ID
    2019-1478
    # of Openings
    1
    Category
    Clinical
  • Overview

    The Director/ Senior Medical Director Oncology within the Clinical Development Department is responsible for providing the medical input and medical oversight for early or late stage Oncology clinical development programs. Strategic responsibilities include design and execution of clinical development plans for oncology products from preclinical research, First in Man studies through Phase I/II/III Clinical Trials.

     

    The incumbent will successfully lead clinical trials Phase I - III, develop and author the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.) and provide expert clinical oncology input and review of the study data as well as lead publication of documents required.  S(he) will provide medical oversight of all studies within their program as well as leadership of clinical study teams. S(he) will work closely with a clinical scientist to provide support for development of the program including preparation of briefing documents, supportive materials necessary to progress strategic development and discussion of the program internally and externally.

     

    S(he) will be responsible for representing the company and its development program and the respective trials when engaging  KOL’s or other leaders in the field.

    Responsibilities

     

    • Collaborate with a growing Clinical Development Team with responsibility for an assigned clinical trial program.
    • Support the clinical development strategy for one or more indications including successful regulatory submission.
    • Design and optimize clinical protocols and trial design.
    • Work with clinical scientists in overseeing the quality, coordination and timeliness of protocol development
    • Guide the work of clinical study managers and is responsible for quality and timeliness of study execution.
    • Provide medical monitoring services and oversight of CRO medical monitors
    • Prepare the medical review and interpretation of efficacy and safety data.
    • Assure quality, coordination, medical accuracy and timeliness of clinical study reports.
    • Collaboratively prepare abstracts, manuscripts and presentations for external meetings, and author clinical sections of the regulatory documents (IB, IND sections).
    • Support colleagues in overseeing preparation of the clinical sections of the INDs, IBs, CTAs, ISS’s, and clinical expert reports.
    • Prepare data and findings formeetings (internal, DSMC, KOL and investigator meetings).
    • Establish and foster effective working relationships with study investigators, KOLs, academicians and internal colleagues.
    • Ensure adherence to GCP/ICH and AAA SOP standards.
    • Maintain current knowledge of clinical and scientific developments
    • The Medical Director Oncology position interacts with the Departments of Clinical Operations, Medical Affairs, HCP, Regulatory Affairs , Preclinical and others.
    • Travel for this position will be expected to be less than 30%

    Qualifications

    A Medical Degree (MD or MD/PhD or DO) is required with a minimum of 2 years of industry experience. Board eligibility or certificationin Internal Medicine or Medical Oncology is preferred

     

    • Solid understanding of drug development process.
    • Working knowledge of GCP, FDA regulations/guidelines, and applicable international regulatory requirements.
    • Ability to provide scientific/clinical expertise to clinical development program.
    • Strong interpersonal, communication (written and verbal) and presentation skills.
    • Effective leadership, organizational and project management skills.
    • Ability to work well within a matrix team structure
    • Solid tumor oncology experience is preferred but someone with Malignant Hematology experience will be considered.
    • Therapeutic or disease area sub-specialty or certification a plus.
    • 3 years clinical medicine experience and 2+ years in pharma/biotech.
    • Clinical trial design Phase I – III experience is preferred.

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