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    Sr. Medical Director - Drug Safety And Pharmacovigilance (Remote)

    Lifelancer
    10+ years
    Not Disclosed
    Remote, USA
    10 Nov. 5, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Sr. Medical Director - Drug Safety and Pharmacovigilance (Remote)
    Location: United States (Remote)
    Duration: Full-Time
    Payrate: Competitive, Based on Experience

    About Legend Biotech:

    Legend Biotech is a global biotechnology company focused on developing innovative therapies to treat life-threatening diseases. Headquartered in Somerset, New Jersey, the company specializes in advanced cell therapies, including chimeric antigen receptor T-cell (CAR-T) and natural killer (NK) cell-based immunotherapy. Legend Biotech is collaborating with Janssen, a pharmaceutical division of Johnson & Johnson, to develop and commercialize ciltacabtagene autolecuel (cilta-cel) for the treatment of multiple myeloma. With a mission to cure and treat devastating diseases, Legend Biotech is committed to advancing cutting-edge therapies worldwide.

    Role Overview:

    Legend Biotech is seeking a Sr. Medical Director - Drug Safety and Pharmacovigilance to join the Clinical Development Team. This remote position plays a critical role in drug safety and pharmacovigilance activities throughout the development lifecycle of assigned compounds. The successful candidate will lead safety strategies, drive risk management initiatives, and ensure alignment with regulatory requirements. This individual will be a key contributor to the medical safety review process, signal detection, and safety assessments, while collaborating with cross-functional teams to ensure high-quality, efficient drug development.

    Key Responsibilities:

    • Pharmacovigilance Strategy: Lead and support the development of drug safety and pharmacovigilance strategies to ensure alignment with clinical development and commercial goals.
    • Signal Detection & Risk Management: Conduct signal detection activities, evaluate safety data, and provide risk-benefit analyses. Manage urgent safety measures in collaboration with cross-functional teams.
    • Safety Monitoring: Lead Safety Monitoring Team (SMT) meetings to assess and manage safety risks. Present unresolved safety issues to senior management for escalation.
    • Medical Safety Review: Provide expert medical safety reviews, including causality assessments, for clinical trial data, pre-clinical data, post-marketing surveillance, and literature.
    • Documentation & Reporting: Oversee the creation of aggregate reports, safety evaluation reports, and responses to regulatory inquiries related to safety topics.
    • CRO & Vendor Oversight: Lead and ensure effective oversight of Contract Research Organization (CRO) activities and manage external vendor relationships.
    • Budget & Resource Management: Lead the drug safety budget process and manage resources effectively to ensure timely and successful delivery of safety objectives.
    • Cross-functional Collaboration: Collaborate with internal and external stakeholders, including clinical, regulatory, and strategic partners, to support global safety initiatives.
    • Leadership & Team Management: Manage and mentor internal safety scientists and teams, providing leadership to ensure successful project delivery.

    Requirements:

    • Education: MD, MBBS, MD-PhD, or equivalent medical degree required.
    • Experience: 5+ years in drug safety and pharmacovigilance within the pharmaceutical industry, with expertise in regulatory requirements for the US and EU.
    • Skills: Strong understanding of pharmacovigilance regulations, signal detection, and risk management. High-level medical competence with the ability to drive business outcomes.
    • Leadership: Proven experience in managing teams, coaching, mentoring, and driving performance through effective leadership.
    • Regulatory Experience: Experience with IND, NDA/BLA submissions, and regulatory interactions is highly desirable.
    • Biotech Experience: Experience in biotech is preferred but not required.
    • Communication: Excellent communication, organizational, and analytical skills, with the ability to translate complex data into actionable strategies.

    How to Apply:

    To apply for this position, please visit the following link:
    Sr. Medical Director - Drug Safety and Pharmacovigilance Application

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