Job Responsibilities
1. End-to-End Management of CAR-T R&D Projects
• Support the initiation and evaluation of CAR-T R&D projects, including defining project objectives, milestones, and development plans, and monitoring key deliverables.
• Assist in tracking project progress and conducting variance analysis; coordinate cross-functional resources (Discovery, PD/CMC and Clinical teams etc.) to resolve issues and ensure projects are delivered on schedule.
• Support project budget management and ensure rational and efficient use of R&D investment.
2. Cross-Functional Collaboration and Resource Integration
• Coordinate closely with R&D, Clinical, PD/CMC Management, Regulatory Affairs, Quality, and other internal teams to ensure information alignment and goal consistency.
• Interface with external partners and CROs, managing technology transfer, data delivery, and compliance review activities.
3. Regulatory Compliance and Risk Management
• Maintain solid knowledge of CAR-T–related regulations; identify project risks, develop mitigation strategies, and provide regular updates to management.
4. Technical and Scientific Support
• Participate in technical discussions related to CAR-T products; understand critical quality attributes (CQAs) and provide directional support for process development and quality studies.
• Monitor industry trends and scientific advancements to support pipeline strategy and portfolio planning.
5. Documentation and Knowledge Management
• Ensure project documentation complies with relevant regulatory and internal standards; maintain timely archiving and version control.
6. Other tasks assigned by management
Qualifications
1. Education & Academic Background
• Master’s degree, or Ph.D degree in Biotechnology, Biopharmaceutical Sciences, Medicine, Immunology, Bioengineering, or related fields preferred.
• Background in molecular biology, cell biology, immunology or virology is a plus.
2. Industry Experience
• At least 5 years of R&D project management experience in the pharmaceutical or biotech industry;
• Minimum 2 years of end-to-end project management experience in CAR-T, cell therapy, or monoclonal antibody (mAb) programs.
• Proven experience in successfully advancing CAR-T or mAb products into Phase I or Phase II clinical trials is highly preferred.
• Familiar with the full development lifecycle of cell therapies; knowledge of viral vector manufacturing and T-cell expansion technologies is a plus.
3. Core Competencies
• Strong understanding of domestic and international pharmaceutical regulations.
• Excellent cross-functional communication and coordination skills, with the ability to drive collaboration among technical, clinical, and manufacturing teams.
• Excellent written and reading English skills; fluent spoken English is a plus.
• Strong passion for the cell therapy field, with an innovative mindset, resilience under pressure, and strong problem-solving ability in a fast-paced R&D environment.
• Strong logical thinking, data analysis capability, and scientific rigor.