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, wor... more details
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 a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
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) in 2017. 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.
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
#Li-JK2
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
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