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

    Legend Biotech Us
    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 & Pharmacovigilance (Remote)
    Location: United States (Remote)
    Duration: Full-Time
    Company: Legend Biotech

    Company Overview:

    Legend Biotech is a global biotechnology company dedicated to developing breakthrough therapies for life-threatening diseases. Headquartered in Somerset, New Jersey, Legend Biotech is at the forefront of cell therapies, including autologous and allogenic chimeric antigen receptor T-cell (CAR-T) and natural killer (NK) cell-based immunotherapies. Through a strategic collaboration with Janssen, a pharmaceutical company of Johnson & Johnson, Legend is advancing the development and commercialization of ciltacabtagene autolecuel (cilta-cel) for the treatment of multiple myeloma.

    Role Overview:

    Legend Biotech is seeking an experienced Sr. Medical Director, Drug Safety & Pharmacovigilance to join the Clinical Development Team in a remote role based in the United States. This leadership position will play a pivotal role in overseeing the drug safety strategy for assigned compounds, ensuring compliance with regulatory requirements, and leading cross-functional efforts to evaluate and manage safety data. The Sr. Medical Director will provide expert guidance on risk management, signal detection, and the safety profile of compounds from clinical development through post-marketing surveillance.

    Key Responsibilities:

    • Pharmacovigilance Strategy: Lead the development and execution of drug safety and pharmacovigilance strategies, ensuring compliance with both corporate goals and regulatory requirements.
    • Signal Detection & Safety Monitoring: Oversee signal detection, safety monitoring, and risk-benefit assessments. Lead Safety Monitoring Team (SMT) meetings to evaluate safety risks and escalate unresolved safety issues to senior management.
    • Safety Data Review: Conduct medical safety reviews, including causality assessments, of pre-clinical, clinical, post-marketing, and literature safety data for assigned compounds.
    • Regulatory Compliance: Provide medical input for regulatory documents, including INDs, NDAs, BLAs, and clinical study reports (CSRs), and respond to safety-related inquiries from regulatory authorities.
    • Urgent Safety Measures: Lead identification and management of urgent safety measures, collaborating with cross-functional teams.
    • Reports & Documentation: Oversee the preparation of aggregate safety reports, signal evaluation reports, and other essential safety documentation.
    • CRO & Vendor Oversight: Provide leadership and oversight of Contract Research Organizations (CROs) and external vendors to ensure the effective delivery of safety-related services.
    • Team Leadership: Lead internal safety scientists and operations teams, providing mentorship and performance management.
    • Budget & Resource Management: Develop and manage the drug safety budget, ensuring resources are allocated efficiently to meet project goals.
    • Cross-Functional Collaboration: Collaborate with cross-functional teams, including clinical, regulatory, and external stakeholders, to ensure the effective execution of safety initiatives.
    • Risk Management: Identify and mitigate project risks in partnership with cross-functional teams, ensuring that delays are addressed and resolved proactively.

    Requirements:

    • Education: MD, MBBS, MD-PhD, or equivalent medical degree required.
    • Experience: Minimum of 5 years of pharmaceutical experience in Drug Safety & Pharmacovigilance, with strong knowledge of US and EU pharmacovigilance regulations.
    • Medical Competence: High level of medical expertise with the ability to balance industry standards to drive business outcomes.
    • Regulatory Experience: Experience in supporting drug safety activities for registrational clinical studies and prior experience with IND, NDA/BLA filings and regulatory interactions is highly desirable.
    • Leadership: Proven track record of managing and mentoring teams, as well as leading cross-functional collaborations in a matrix environment.
    • Skills: Excellent leadership, organizational, analytical, and presentation skills. Ability to translate complex safety data into actionable clinical strategies.
    • Biotech Experience: Experience in biotech is preferred but not required.

    How to Apply:

    For more information and to apply, please visit:
    Sr. Medical Director - Drug Safety & Pharmacovigilance Application

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