• LFB USA - Medical Director

    Job Locations US-MA-Framingham
    Job ID
    2018-1336
    # of Openings
    1
    Category
    Clinical/Medical
    Type
    Full Time
    Company
    LFB USA
  • Overview

    The Medical Director will support development and execution of the clinical strategy for assigned programs at LFB USA in order to meet company objectives. The Medical Director is a resource internally and externally on all medical and clinical topics. He/she will work closely with clinical and regulatory teams at LFB globally and serves as a key strategic and medical point person during the conduct of trials and in the presentation of clinical data. Will provide medical support in conjunction with health authority meetings (FDA/EMA/other).

    Responsibilities

    • Support Clinical Development activities for assigned projects.
    • Assist in the design of clinical development strategies in conjunction with other relevant functional area leaders in Regulatory, Clinical Operations, Biometry, Commercial, Medical Affairs, Pharmaceutical Development, Research, Business Development, and Marketing.
    • Interface with U.S. and International regulatory authorities.
    • Initiate development of study protocols.
    • Ensure initiation of appropriate clinical trial sites.
    • As necessary, assume medical monitor responsibility for clinical trials, including assessment of patient eligibility and responses to study design questions.
    • Ensure that all quality and ethical standards (compliance with SOPs, ICH, GCP and other national and international regulatory requirements) are met.
    • Provide specific therapeutic area expertise to enhance innovation and efficiency in clinical development.
    • Provide lead medical and clinical support and expertise for regulatory submission including strategy, planning, and development..
    • Act as key reviewer of business-critical documentation (e.g., clinical development plans, clinical protocols, Investigator brochures, clinical study reports, summaries of clinical pharmacology, clinical efficacy and clinical safety, posters, abstracts, publications, corporate communications, etc.)
    • Develop KOL relationships in the US and internationally for therapeutic areas of interest at LFB.
    • Stay professionally current and establish relationships with key opinion leaders, external advisors and collaborators.

    Qualifications

    Education/Experience:

     

    • Medical Doctor Degree required (U.S.) with experience in Hematology, Immunology or Pathology
    • Clinical development, clinical operations, and medical affairs experience desired
    • Experience/exposure to the successful development and approval of complex biological compounds
    • Experience/exposure to the successful development of therapeutics for orphan indications
    • Knowledge of procedures and interactions at major health authorities in the U.S. and Europe helpful

     

    Capabilities:

    • Pro-active, energetic, out-of-the-box thinker
    • Excellent communication and presentation skills with the ability to influence internal and external partners
    • Strong project management skills
    • Excellent writing skills
    • Advanced ability to use all Microsoft Office Applications

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