Legend Biotech is seeking an Associate Director, 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 Director 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. The Associate Director, Clinical Research Scientist is expected to provide significant decision-making input on the clinical development/regulatory strategy and data analysis/interpretation, and has responsibility for overall quality of clinical development program from IND to BLA.

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 leads. Uses clinical and disease state knowledge to develop methods and strategy for data cleaning approach and may oversee other clinical scientists to execute on data cleaning for deliverables.
• Collaborate with other functions to successfully lead, plan and execute clinical studies. Provides independent leadership of all areas requiring clinical input with minimal oversight or in equal partnership with medical director and proactively identifies issues and provides innovative and quality solutions
• Responsible to provide expert clinical input and strategic decision-making for the planning and implementation of assigned clinical trial(s) including investigator selection, patient recruitment, clinical portion of feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions.
• Lead the preparation and review of all clinical documents in partnership with medical director (Protocol, ICFs, CSR, investigator brochure).
• Responsible to provide expert clinical input and strategic decision-making 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 and proactively seeks to harmonize across programs and make process improvements (eg: Case Report Forms, edit checks, data review plan and reports)
• Contribute significantly to the clinical strategy outlined in the Global Clinical Development Plan (CDP) for compounds in clinical development or new clinical entities, working closely with medical lead and other stakeholders and cross functional teams.
• Lead in planning and execution of external meetings and internal stakeholder meetings in partnership with medical director, and shares speaking role for meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations.
• Expected to represent CS function in cross functional activities and contribute to harmonization between clinical trials and process improvement initiatives

Requirements

• Bachelor’s degree with 8 years’; or MS with 7 years’; or PharmD/PhD with 6 years of pharma experience in clinical development or a related field
• CAR-T cell therapy 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

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