Description

You will independently lead clinical science workstreams for late-stage oncology programs, contributing to pivotal studies, regulatory submissions, and cross-functional execution to advance targeted therapies for RAS-addicted cancers.

Requirements

• Bachelor's degree in life sciences; advanced degree (PharmD, PhD, MSN, MPH) preferred
• 5+ years clinical development experience in pharma, biotech, or academic clinical research
• Experience contributing to pivotal or registration-enabling studies
• Strong knowledge of GCP, ICH, FDA, EMA, and other regulatory guidelines
• Proven ability to work effectively in cross-functional teams and manage multiple deliverables

Responsibilities

• Lead defined clinical science workstreams within pivotal and registration-enabling studies
• Contribute to protocol development, CRF design, ICF updates, and alignment with regulatory standards
• Drive ongoing clinical data review including plausibility, query trend analysis, and preparation for database lock
• Accountable for clinical science deliverables supporting regulatory submissions (CSR sections, briefing packages, HA responses)
• Collaborate with cross-functional teams (Biostatistics, Data Management, Medical Writing, etc.) for alignment and submission readiness