Clinical Research Scientist - Pediatric
Behavioral Health Market Context
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Qualifications
- •Doctoral Degree BPhD, PharmD, MD (non‑clinical track), or equivalent doctoral degree in biomedical sciences, clinical research, pharmacology, or a related field
- •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
- •2 more items(s)
Responsibilities
- •This 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
- •Assists in the design and development of early phase oncology 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
- •18 more items(s)
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