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

    Lifelancer
    5+ years
    Not Disclosed
    Jersey City
    10 Nov. 18, 2024
    Job Description
    Job Type: Full Time 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

    Sr. Medical Director - Drug Safety and Pharmacovigilance (Remote)
    Location: United States

    Company Overview:
    Legend Biotech is a global biotechnology company focused on treating and curing life-threatening diseases. Headquartered in Somerset, New Jersey, the company develops advanced cell therapies, including autologous and allogenic chimeric antigen receptor T-cell (CAR-T) and natural killer (NK) cell-based immunotherapies. Partnering with Janssen, a pharmaceutical company of Johnson & Johnson, Legend Biotech is advancing immunotherapy for the treatment of multiple myeloma.

    Role Overview:
    The Sr. Medical Director, Drug Safety and Pharmacovigilance plays a pivotal role in the clinical development process, providing expertise on drug safety and risk management. This role will lead and support pharmacovigilance strategy and initiatives, ensuring compliance with global regulatory requirements while actively managing the safety profile of assigned products throughout their lifecycle. The Sr. Medical Director will drive proactive signal detection, safety assessments, and collaboration with cross-functional teams to achieve clinical goals.

    Key Responsibilities:

    • Lead and develop pharmacovigilance strategies to ensure compliance with clinical development and commercial goals.
    • Conduct signal detection, monitoring, and evaluation of safety data from clinical trials, pre-clinical studies, post-marketing, and literature sources.
    • Facilitate Safety Monitoring Team (SMT) meetings to evaluate the risk-benefit of compounds, escalating unresolved safety issues to senior management.
    • Conduct medical safety reviews, including causality assessments, for safety data generated throughout product development.
    • Provide medical expert input into critical documents for clinical development (INDs, NDAs, BLAs, protocols, ICFs, clinical research reports).
    • Identify and manage urgent safety measures with cross-functional support.
    • Oversee and contribute to the preparation of aggregate and signal evaluation reports for assigned projects.
    • Respond to regulatory inquiries related to safety topics with clinical content support.
    • Provide leadership to Contract Research Organizations (CROs) and ensure vendor oversight.
    • Manage and oversee internal safety scientists and safety operations teams.
    • Develop SOPs to ensure regulatory compliance and guide procedures to achieve company goals.
    • Lead drug safety budget development and manage resources and expenses effectively.
    • Plan and execute external and internal meetings (e.g., IMs, Governance, DMCs, Regulatory Authority meetings).
    • Collaborate effectively with internal and external stakeholders to drive organizational engagement.
    • Identify project risks and work with teams to mitigate delays and resolve issues with transparency to senior leadership.
    • Prepare progress reports and ad-hoc reports as required.
    • Support process improvement initiatives and functional training at the company level.
    • Maintain high ethical standards and compliance with corporate policies and healthcare laws.

    Requirements:

    • MD, MBBS, MD-PhD, or equivalent medical degree.
    • 5+ years of experience in Drug Safety Pharmacovigilance within the pharmaceutical industry.
    • Strong understanding of pharmacovigilance regulations in the US and EU.
    • Experience in drug safety activities for registrational clinical studies.
    • High-level medical competence and the ability to align industry standards with business objectives.
    • Expertise in scientific analysis, drug development processes, and regulatory submissions (IND, NDA/BLA).
    • Experience leading and managing teams, including performance management and training.
    • Strong organizational, analytical, and presentation skills, with experience translating data into clinical strategies.
    • Biotech experience is preferred, but not required.

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