the client is a clinical-stage biopharmaceutical company advancing therapies for genetic diseases. The role focuses on establishing and implementing strategies for investigator-initiated trials (IIT) and clinical trial applications (CTA) in China, tailored to specific indications and modalities, to support early clinical development across multiple genetic medicine programs.
The successful candidate will lead global clinical development for programs with first-in-human (FIH) trials initiated in China, including the design and execution of early proof-of-concept (PoC) studies, and will co-lead China site development for global trials that include Chinese sites. As a core member of global program teams, they will represent China clinical development and ensure alignment with global development strategy, governance, and decision-making. They will also partner cross-functionally with Clinical, Regulatory, Safety, Biometrics, and CMC teams in both China and the U.S. to drive high-quality, compliant, and efficient trial execution, while supporting due diligence and asset evaluation for China-originated opportunities and programs with major China involvement.
Required qualifications include an M.D., M.D./Ph.D., or equivalent clinical doctoral degree, along with 10+ years of clinical development experience and 5+ years in senior leadership roles advancing programs through FIH and early-stage development, with a biotech background preferred. The role expects a demonstrated track record owning company-sponsored interventional trials and overseeing IITs, including investigator and site network development, CRO/vendor oversight, and full budget accountability. Additional expectations include experience contributing to global development team strategy and governance with strong English communication, experience advancing assets from IND through early PoC with hands-on leadership in study design, execution, and data interpretation, strong clinical pharmacology/PK-PD orientation, direct regulatory leadership experience (including pre-IND/IND meetings, written submissions, and safety-related communications), and the ability to build and scale lean clinical organizations while mentoring and developing talent.