Description

You will serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio, leading clinical science aspects of the clinical development strategy and driving end-to-end data cleaning to support successful regulatory submissions.

Requirements

• M.D. or equivalent with oncology experience
• Proven expertise in clinical trial data review, cleaning, and regulatory submission preparation
• Experience with FDA, EMA, and ICH standards for NDA/BLA/MAA filings
• Strong leadership and cross-functional collaboration skills
• Ability to oversee clinical trial design and execution

Responsibilities

• Lead clinical science aspects of clinical development strategy and documentation
• Ensure data integrity through query resolution and clinical plausibility review
• Drive end-to-end data cleaning strategy for regulatory submission readiness
• Partner with regulatory, biostatistics, and data management for NDA/BLA/MAA filings
• Lead clinical data review meetings and mentor cross-functional teams