Senior Clinical Research Scientist
Legend Biotech
12 days ago
Remote friendly (Somerset, NJ)
United States
Clinical Research and Development
Role Overview
- The Senior Clinical Research Scientist (Clinical Development) supports the development and life cycle of drug development projects, working with Clinical Trial Lead/Medical Lead and Clinical Trial Manager to design/implement protocols and manage sites, CROs, and related work.
Key Responsibilities
- Ensure data review/cleaning meets quality standards to support database locks; recommend methods/strategy for data cleaning.
- Collaborate to plan and execute clinical studies; provide independent clinical input leadership with oversight.
- Provide clinical input and strategic recommendations for assigned trials (investigator selection, patient recruitment, feasibility questionnaire, training materials, ethics committee submissions).
- Contribute to clinical documents (Protocol, ICFs, CSR, investigator brochure); may lead sections.
- Provide input for regulatory documents across trial lifecycle (IND, briefing books, BLAs, Orphan Drug Applications).
- Own clinical portions of data management/statistical documents (CRFs, edit checks, data review plan/reports).
- Support external/internal meetings (Ad Boards, IMs, Governance, DMCs, authorities); triage/escalate questions as needed.
Requirements
- Bachelor’s in life sciences; plus 4+ years (or MS 3+ years; or PharmD/PhD 2+ years in clinical development/related).
- GCP, FDA, and ICH guideline knowledge.
- Strong communication, leadership/organization, analytical/presentation skills; conflict/negotiation ability; multitasking; computer literacy (Word/Excel/PowerPoint/Project).
- Preferred: oncology therapeutic experience; plus CAR-T and/or hematology/oncology experience.
Benefits
- Medical/dental/vision; 401(k) with match (vests day one).
- 8 weeks paid parental leave after 3 months.
- PTO (vacation/personal/sick/floating holidays) + 11 company holidays.
- The Senior Clinical Research Scientist (Clinical Development) supports the development and life cycle of drug development projects, working with Clinical Trial Lead/Medical Lead and Clinical Trial Manager to design/implement protocols and manage sites, CROs, and related work.
Key Responsibilities
- Ensure data review/cleaning meets quality standards to support database locks; recommend methods/strategy for data cleaning.
- Collaborate to plan and execute clinical studies; provide independent clinical input leadership with oversight.
- Provide clinical input and strategic recommendations for assigned trials (investigator selection, patient recruitment, feasibility questionnaire, training materials, ethics committee submissions).
- Contribute to clinical documents (Protocol, ICFs, CSR, investigator brochure); may lead sections.
- Provide input for regulatory documents across trial lifecycle (IND, briefing books, BLAs, Orphan Drug Applications).
- Own clinical portions of data management/statistical documents (CRFs, edit checks, data review plan/reports).
- Support external/internal meetings (Ad Boards, IMs, Governance, DMCs, authorities); triage/escalate questions as needed.
Requirements
- Bachelor’s in life sciences; plus 4+ years (or MS 3+ years; or PharmD/PhD 2+ years in clinical development/related).
- GCP, FDA, and ICH guideline knowledge.
- Strong communication, leadership/organization, analytical/presentation skills; conflict/negotiation ability; multitasking; computer literacy (Word/Excel/PowerPoint/Project).
- Preferred: oncology therapeutic experience; plus CAR-T and/or hematology/oncology experience.
Benefits
- Medical/dental/vision; 401(k) with match (vests day one).
- 8 weeks paid parental leave after 3 months.
- PTO (vacation/personal/sick/floating holidays) + 11 company holidays.