[Onconic Therapeutics] Director, Clinical Development (U.S. Clinical Program Lead)

U.S.-based  |  Full-time  |  Director or Senior Manager level, depending on experience

Overview

Onconic Therapeutics is seeking a U.S.-based clinical development leader to run our U.S. clinical program. The Director will be the accountable head of the program in the U.S., directing the engaged global CRO and vendors and working with our regulatory, CMC, biostatistics, and pharmacovigilance teams in Korea.

Responsibilities

• Lead our U.S. clinical program from FDA alignment and protocol finalization through start-up, enrollment, database lock, and clinical study report
• Direct the CRO and specialty vendors: scope, budget, timelines, KPIs, and governance
• Own U.S. site and investigator strategy, enrollment, and ICH-GCP/FDA compliance
• Lead FDA interactions and IND maintenance for the program, with support from our regulatory team and consultants
• Manage program timeline and budget, report to senior leadership, and build the U.S. clinical team as needed

Qualifications

• 10+ years in clinical development or clinical operations in biopharma (7+ years considered at the Senior Manager level)
• Led a pivotal or late-stage U.S. clinical study as sponsor, from start-up through database lock
• Experience managing global CROs in a fully outsourced model; working knowledge of ICH-GCP and FDA regulations
• GI experience and Korean language ability are a plus, not required

How to Apply

Email your CV/resume to recruit@recruit0507.com with "[Application for Director, Clinical Development]" in the subject line. Applications are reviewed on a rolling basis and treated in confidence.