Head of Clinical & Data Sciences
About The Position
The Head of Clinical & Data Sciences is a leadership role responsible for shaping, directing, and overseeing the clinical and data science strategy across the company’s development portfolio. This individual integrates clinical science, biostatistics, data management and advanced analytics to drive data‑informed decision‑making from first‑in‑human studies through global regulatory submissions. The role requires deep experience in clinical trial design, complex data interpretation, regulatory strategy, and cross‑functional leadership, with a demonstrated track record of global submissions, regulatory interactions, end‑to-end program ownership, and organizational leadership.
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.
- 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.
- Exceptional scientific judgment integrating complex datasets into program‑shaping decisions.
- Strong command of global regulatory frameworks and expectations across phases.
- Ability to operate at both strategic and execution levels in a fast‑paced environment.
- Highly effective communicator with ability to influence senior leaders and regulators.
- Proven leadership and mentoring skills within multidisciplinary scientific teams.
Nice To Haves
- Experience in bladder cancer disease area is preferred.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
