Research Scientist Phase I Oncology Clinical Trials

Description

Job Summary

The Clinical Research Scientist supports the scientific development, implementation, and analysis of early phase (Phase I/first in child) oncology clinical trials within the Clinical Trials Unit at Nicklaus Children's Health System (NCHS). The role partners closely with the Medical Director and Pediatric Clinician Scientists to advance innovative therapeutics for children and adolescents with high risk or refractory malignancies. The Clinical Research Scientist plays a critical role in protocol development, translational integration, data interpretation, regulatory documentation, and dissemination of research findings, strengthening the scientific rigor and operational success of early phase pediatric oncology trials.

Job Specific Duties

• Assists in the design and development ofearly phaseoncology protocols.
• Contributes to study rationale, objectives, eligibility criteria, and correlative science components.
• Develops statistical analysis plans in collaboration with biostatistics teams.
• Contributes to study rationale, objectives, eligibility criteria, and correlative science components.
• Collaborates with investigators, regulatory staff, and research coordinators during study activation.
• Participate in dose-escalation meetings and safety review discussions.
• Supports DSMB reporting and pharmacovigilance documentation.
• Ensure scientific accuracy of consent forms, protocol amendments, and safety reports.
• Analyzes clinical and translational datasets, including PK/PD and biomarker data.
• Prepares interim reports, abstracts, and manuscripts.
• Contributes to regulatory safety updates and sponsor communications.
• Develops presentations for internal leadership and external stakeholders.
• Coordinates biospecimen collection and correlative science workflows.
• Partners with laboratory scientists to integrate molecular and genomic findings into trial design.
• Supports precision oncology and biomarker-driven strategies within the Pediatric Early Phase Oncology Program.
• Contributes to grant applications and progress reports.
• Assists in the identification and development of grant opportunities including federal, state and foundation grants.
• Co-authors peer-reviewed publications.
• Presents findings at national scientific meetings.

Qualifications

Minimum Job Requirements

• Doctoral Degree BPhD, PharmD, MD (non-clinical track), or equivalent doctoral degree in biomedical sciences, clinical research, pharmacology, or a related field.

Knowledge, Skills, and Abilities

• Advanced scientific reasoning and clinical trials methodology knowledge.
• Strong understanding of regulatory and compliance principles in clinical research.
• Cross-disciplinary collaboration skills across clinical, regulatory, data, and laboratory teams.
• High proficiency in data interpretation, PK/PD and biomarker analysis, and scientific communication.