Head of Clinical and Data Sciences

Role Overview

• Provide scientific leadership across all clinical programs from early development through late‑stage global registrational trials.
• Oversee authorship, development, and strategic review of protocols, IBs, SAPs, CSRs, DSURs, ICFs, eCRFs, and clinical modules of major submissions.
• Lead global regulatory interactions (FDA, EMA, MHRA, PMDA), including briefing docs, written responses, and meeting preparations.
• Direct quantitative strategy across programs, integrating clinical data, real‑world evidence, model‑informed drug development, and exploratory biomarker analyses.
• Ensure robust data quality, oversee scientific data reviews, and resolve complex data issues.
• Lead scientific strategy for regulatory submissions (IND, CTA, BLA, MAA, sBLA/sNDA).
• Drive scientific publication strategy and represent the company in scientific forums.
• Provide leadership to Clinical Scientists, Statisticians, and cross‑functional partners.

Requirements

• Advanced degree required (PhD, PharmD, MD, or equivalent).
• 8+ years industry experience in clinical development, clinical science, or quantitative sciences.
• Significant global submission experience in oncology or urology disease area with direct leadership of key modules. Experience in bladder cancer disease area is preferred.
• Demonstrated leadership in designing and executing complex Phase I–III clinical trials.
• Experience leading scientific interactions with global health authorities.
• Deep understanding of biostatistics, data management, and real‑world data integration.
• Experience building and managing high‑performing scientific and data teams.