Senior Project Manager to Associate Director, Clinical Project Management

【Key Responsibilities】

<p>Oversight of clinical studies through collaboration with various CROs. Develop comprehensive project plans, timelines, budgets, and risk management strategies; monitor progress and implement corrective actions as needed.</p> <p>Coordinate and manage global clinical studies, with a strong emphasis on U.S.-China dual regulatory submissions (FDA and NMPA), ensuring alignment of study design, endpoints, and operational execution to meet both agencies’ expectations.</p> <p>Oversee vendor selection, contract negotiation, and performance management of external partners (e.g., CROs, central labs).</p> <p>Prepare and present project updates, milestones, and critical issues to senior management and governance committees.</p> <p>Contribute to regulatory submissions (IND, NDA, BLA, etc.) by providing clinical operations input and supporting documentation.</p> <p>Identify and engage with study sites (Investigators, study nurses, etc.) to ensure smooth trial execution and address site-related issues.</p> <p>Collaborate closely with internal teams to drive project success and facilitate cross-departmental meetings to resolve interdepartmental challenges and promote synergy.</p> <p>Establish and maintain a robust documentation management system for secure storage, timely updates, and easy access.</p>

【Qualifications】

<p>Master degree or above in Medicine, Pharmacy, Life Sciences, or a related scientific field.</p> <p>Minimum of 3–5 years of clinical trial project management experience in the pharmaceutical, biotechnology industry.</p> <p>Demonstrated experience in oncology or immunology clinical development, including hands-on management of Phase I trials (Phase II/III will be a plus).</p> <p>Proven track record of independently leading clinical projects from initiation (full cycle experience will be a plus).</p> <p>Essential experience in managing or supporting clinical trials in the U.S., including interaction with U.S.-based regulatory bodies, investigators, or CROs.</p> <p>Certain understanding of clinical development processes and regulatory requirements in both the U.S. (FDA) and China (NMPA), with direct involvement in dual-submission strategies.</p> <p>Fluent in English, with strong spoken and written communication skills – must be able to conduct meetings, write reports, and negotiate contracts in English.</p>