Senior Clinical Scientist
Core
Designing and executing early-phase (Phase 1-2) clinical trials for oncology and endocrinology drug candidates, integrating preclinical findings into clinical strategies.
Role type
Senior Clinical Scientist (Early-Phase Clinical Development)
Builds
Phase 1-2 clinical trials, IND/CTA submissions, Clinical Study Reports (CSRs)
Domain
Biopharmaceuticals, Oncology, Endocrinology
Required skills
Clinical trial design, Protocol authoring, Regulatory submissions (IND/CTA), Medical monitoring, Safety/efficacy data review, PK/PD assessment, GCP/ICH compliance
Preferred skills
Translational science integration, Biometrics partnership, Investigator engagement
Technologies
GCP, ICH guidelines, Clinical trial design tools
Responsibilities
Develop clinical study protocols and Investigator's Brochures for dose escalation studies; Author clinical sections for global regulatory submissions; Support medical monitoring and present safety data at SMC meetings; Collaborate with Translational Science, Biometrics, and Clinical Operations teams; Ensure adherence to GCP/ICH standards.
Seniority
Senior, hands-on IC