US: Senior Clinical Research Scientist

ly these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Role Overview:
Senior Clinical Research Scientist as part of the Clinical Development team based in Somerset, NJ
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The Clinical Research Scientist (CS) in Clinical Development supports the development and lifecycle of drug development projects. The CS will work closely with the Clinical Trial Lead/Medical Lead and Clinical Trial Manager to design and implement clinical trial protocols and manage sites, CROs and related work. The CS will support their manager to ensure program consistency and alignment across studies, working with cross-functional teams to achieve project goals within timelines and high quality.

This role supports early phase drug development in autoimmune indications.
Responsibilities
• Ensure data review and cleaning activities meet quality standards to support database locks in collaboration with data management and medical/clinical trial leads; use clinical and disease state knowledge to make recommendations for data cleaning methods and strategy.
• Collaborate with other functions to plan and execute clinical studies; provide independent leadership of all areas requiring clinical input with oversight from the assigned Clinical Trial Lead/Medical Lead; offer innovative and quality solutions for assigned problems and tasks.
• Provide clinical input and strategic recommendations for planning and implementation of assigned clinical trials including investigator selection, patient recruitment, feasibility questionnaire, training materials, and supporting Ethics committee submissions.
• Contribute to planning, preparation, and review of clinical documents (Protocol, ICFs, CSR, investigator brochure); may lead certain documents or sections and incorporate input from cross-functional team members.
• Provide clinical input and strategic recommendations for regulatory documents across all stages of the trial lifecycle (IND documentation, HA briefing books, BLAs, Orphan Drug Applications).
• Contribute to clinical portions of data management/statistical documents (e.g., Case Report Forms, data edit checks, data review plans and reports).
• Participate in planning and execution of external and internal stakeholder meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meetings); respond to questions for escalation and may speak at meetings as appropriate.
• Support harmonization between clinical trials and process improvement initiatives where requested.
• May have decision-making authority on data cleaning queries and escalation decisions with the medical lead; may be delegated tasks related to document creation.
Qualifications
• At least a Bachelor’s degree in a life science discipline.
• Bachelor’s degree with 4+ years; or MS with 3+ years; or Pharm

D/PhD with 2+ years of pharma experience in clinical development or related function.
• CAR-T cell therapy and/or autoimmune disease experience is a plus.
• Strong interpersonal and communication skills, including oral and written communication.
• Ability to manage conflicts and negotiate while providing impact and influence.
• Collaborative with ability to operate across multiple geographies.
• Leadership, organizational, analytical, and presentation skills; creative problem-solving abilities; multitasking capability.
• Computer literacy (MS Word, MS Excel, MS PowerPoint, MS Projects).
• Oncology therapeutic experience preferred.
• Excellent working knowledge of GCP, FDA and ICH guidelines.

EEO Statement

Legend Biotech is an equal employment opportunity employer. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
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