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    Associate Director, Sr. Clinical Research Scientist

    Legend Biotech Us
    6-8 years
    Not Disclosed
    Princeton Junction
    10 July 10, 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, 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

    Position Information:

    • Employer: Legend Biotech USA, Inc.
    • Job Code: 4424911005
    • Category: Director, Clinical Research
    • Location:
      • Country: United States
      • State: New Jersey (NJ)
      • City: Somerset
    • Post Date: 05/29/2024

    Company Information:

    Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across various technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. In 2017, Legend Biotech entered into a global collaboration with Janssen, a Johnson & Johnson pharmaceutical company, to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel) for multiple myeloma treatment.

    Role Overview:

    Legend Biotech is seeking an Associate Director, Clinical Research Scientist to join the Clinical Development team based in Somerset, NJ. The Clinical Research Scientist (CS) will support the development and lifecycle of drug development projects, working closely with the Clinical Trial Lead/Medical Director and Clinical Trial Manager to design and implement clinical trial protocols and manage sites, CROs, and other associated tasks. The role requires significant decision-making input on clinical development/regulatory strategy and data analysis/interpretation, ensuring overall quality from IND to BLA.

    Key Responsibilities:

    • Ensure data review and cleaning activities meet quality standards for database locks, collaborating with data management and medical leads.
    • Develop methods and strategy for data cleaning and oversee other clinical scientists to execute deliverables.
    • Lead, plan, and execute clinical studies with minimal oversight or in partnership with the medical director.
    • Provide clinical input and strategic decision-making for planning and implementation of clinical trials, including investigator selection, patient recruitment, and supporting Ethics committee submissions.
    • Prepare and review clinical documents (Protocol, ICFs, CSR, investigator brochure) in partnership with the medical director.
    • Provide clinical input and strategic decision-making for regulatory documents (IND documentation, HA briefing books, BLAs, Orphan Drug Applications).
    • Oversee clinical portions of key data management/statistical documents and harmonize processes across programs.
    • Contribute to the clinical strategy in the Global Clinical Development Plan (CDP) for compounds in development.
    • Plan and execute external and internal meetings, sharing speaking roles, and addressing questions appropriately.
    • Represent the CS function in cross-functional activities and contribute to process improvement initiatives.

    Requirements:

    • Education:
      • Bachelor's degree with 8+ years
      • MS with 7+ years
      • PharmD/PhD with 6+ years in clinical development or related field
    • Experience:
      • CAR-T cell therapy experience is a plus
      • Oncology Therapeutic Experience preferred
    • Skills:
      • Good interpersonal, communication, leadership, and organizational skills
      • Analytical and presentation skills
      • Creative problem-solving and project management skills
      • Ability to manage conflicts and negotiations effectively
      • Collaborative and able to operate across multiple geographies
      • Computer literacy (MS Word, MS Excel, MS PowerPoint, MS Project)
      • Excellent working knowledge of GCP, FDA, and ICH Guidelines

    Equal Opportunity:

    Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We ensure equal employment opportunities without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, marital status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

    Workplace Policy:

    Legend Biotech maintains a drug-free workplace.

    Application:

    To apply, please visit Legend Biotech Careers.

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