Expert Clinical Research Scientist
Legend Biotech is seeking an Expert 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 Operations Lead 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. At the expert clinical research scientist level, the scientist will be expected to perform with less oversight and with higher impact across the assigned program and the organization as compared to the senior clinical research scientist.
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
- Collaborate with other functions to successfully support the planning and execution of clinical studies. Provides independent leadership of all areas requiring clinical input with some oversight from the assigned Clinical Trial Lead/Medical Lead and proactively produces innovative and quality solutions for issues the trial faces
- Provides 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.
- Contributes to the strategic planning, preparation and review of clinical documents in collaboration with the medical director (Protocol, ICFs, CSR, investigator brochure). Expected to lead certain documents or sections of documents, including incorporation of input from other cross-functional team members.
- Provides 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 (eg: Case Report Forms, edit checks, data review plan and reports)
- May be asked to support creation of 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 the planning and execution of external meetings and internal stakeholder meetings in collaboration with medical director (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations. Expected to have a speaking role on key meetings.
- Represent CS function in cross functional activities and contribute to harmonization between clinical trials and process improvement initiatives.
Requirements
- At least a Bachelor’s degree in life science discipline.
- Bachelor’s degree with 6+ years’; or MS with 5+ years’; or PharmD/PhD with 4+ 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.
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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.
Legend Biotech maintains a drug-free workplace.
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