Description

Legend Biotech is seeking a Senior Clinical Research Scientist as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Clinical Research Scientist (CS) in Clinical Development is an important role in the company supporting the development and life cycle of drug development projects. The Clinical Research Scientist 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 other associated work. In addition, the CS will support their manager to ensure program consistency & alignment across studies, working closely with cross-functional teams for achieving project goals, within timelines & with high quality. This clinical scientist will support early phase drug development in autoimmune indications.

Key Responsibilities

• Responsible to ensure the data review and cleaning activities meet the quality standards to support database locks in collaboration with data management and medical lead/clinical trial lead. Uses clinical and disease state knowledge to make recommendations for methods and strategy for data cleaning approach
• Collaborate with other functions to successfully support the planning and execution of clinical studies. Provides independent leadership of all areas requiring clinical input with oversight from the assigned Clinical Trial Lead/Medical Lead, and provides innovative and quality solutions for assigned problems and tasks.
• Provides clinical input and strategic recommendations for the planning and implementation of assigned clinical trial(s) including investigator selection, patient recruitment, feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions.
• Contributes to the strategic planning, preparation, and review of clinical documents (Protocol, ICFs, CSR, investigator brochure). May lead certain documents or sections of documents, including incorporation of input from other cross-functional team members.
• Provides clinical input and strategic recommendations for regulatory documents needed for all stages of assigned trial lifecycle (IND documentation, HA briefing books, BLAs, and Orphan Drug Applications).
• Responsible for clinical portions of key data management/statistical documents (eg: Case Report Forms, edit checks, data review plan and reports).
• Contribute to the planning and execution of external meetings and internal stakeholder meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations. May have a speaking role on meetings when appropriate.
• Supports their manager when asked to contribute to harmonization between clinical trials and process improvement initiatives.
• May have the authority to make decisions related to issuing data cleaning queries and can decide whether there is a need to escalate for further discussion with the medical lead. They may also be delegated tasks from the clinical trial lead/medical lead for which they have decision making authority e.g. comment resolution when leading document creation.

Requirements

• At least a Bachelor's degree in life science discipline.
• Bachelor's degree with 4+ years'; or MS with 3+ years'; or PharmD/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.
• Good interpersonal & communication skills, including oral, written and interpersonal.
• Ability to effectively manage conflicts and negotiations while providing impact and influence.
• Collaborative with the ability to operate across multiple geographies.
• Good leadership & organizational skills, analytical skills, and presentation skills.
• Creative problem-solving skills.
• Strong organizational and project management skill and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Oncology Therapeutic Experience preferred.
• Excellent working knowledge of GCP, FDA and ICH Guidelines.

#Li-JR1

#Li-Hybrid

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 a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply 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 autolecuel (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.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

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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