Careers

Employment Type: Full-time  Work Location: Shanghai / Beijing / Suzhou (flexible)

Job Responsibilities

• Clinical Project Development: Participate in formulating clinical project development plans and strategies, provide scientific rationality analysis, and evaluate the selection of indications and treatment regimens.
• Medical Monitoring & Support: Provide necessary medical support during clinical studies (including eligibility review, medical monitoring, assessment and analysis of safety events such as SAE/SUSAR, etc.); ensure clinical trials are conducted in strict accordance with SOPs and GCP/ICH guidelines; track and respond to clinically relevant events; organize and analyze efficacy and safety data to support clinical decision-making.
• Medical Review: Participate in the review of SAE reports, medical coding, protocol deviations, and other clinical trial–related documents.
• Medical Writing: Responsible for clinical trial design and drafting clinical study documents, including but not limited to study protocols, investigator brochures, informed consent forms, clinical study summary reports, IND/NDA submission documents, and other medical documents (e.g., medical monitoring plans).
• Coordinate, manage and internally report on collaborations with CRO and SMO personnel.
• Collaborate with R&D and translational teams to fully assess the clinical value, feasibility and risks of pipeline projects and provide clinical evaluation opinions; assist regulatory and clinical operations teams in resolving complex issues during registration and clinical implementation.
• Participate in decision-making of major medical technical schemes related to new drug R&D, formulation of medical plans, and preparation of summary reports.
• Establish and maintain communication channels with regulatory authorities, industry associations, medical experts, research institutes and other relevant stakeholders; track regulatory updates and global medical advances to support project progress.
• Participate in building the clinical medicine team, train and lead the team to achieve established goals.

Job Requirements

• Bachelor’s degree or above in Clinical Medicine.
• At least 3 years of clinical physician experience; oncology experience is preferred.
• At least 2 years of experience as a Medical Monitor for pre-market clinical programs (Phase I–III).
• Experience in clinical research projects with dual US-China filings is preferred.
• IIT project experience is preferred.
• Rare disease project experience is preferred.
• CRO work experience is preferred.
• Experience in organizing, managing and initiating clinical trials, with full-cycle participation in drug clinical development is preferred.
• Strong cross-departmental communication, coordination and collaboration skills.
• Proficiency in written and spoken English.
• Entrepreneurial spirit and strong teamwork mindset.

Employment Type: Full-time  Work Location: Shanghai / Beijing / Suzhou (flexible)

Job Responsibilities

Work with Project Managers and Project Directors to ensure assigned clinical studies comply with ICH-GCP, including study planning, initiation, execution, budgeting, quality control, oversight, CRO/vendor management, and collaboration with CROs (if applicable). Projects include ongoing and future studies in the U.S. and China, as well as IIT studies.

• Ensure smooth start-up and conduct of clinical studies while meeting timelines, budgets and quality standards.
• Support preparation of IND-related documents including study protocols, ICF, IB, etc.
• Manage study planning and initiation activities, including site selection, IRB/EC/HGRAC submissions, TMF preparation, vendor/system setup, clinical supply planning, and clinical development plans.
• Manage patient enrollment and oversee full study conduct; develop and implement risk mitigation/action plans to achieve enrollment targets.
• Coordinate/lead cross-functional CRO selection, management and oversight to ensure timely, high-quality deliverables.
• Manage vendor contracts and monitor performance.
• Conduct co-monitoring to identify site quality issues, guide CRAs on CAPA implementation, ensure resolution, mitigate risks at the project level, and prepare for audits.

Job Requirements

• Bachelor’s degree or above.
• Major in Medicine, Pharmacy, Biology or related field.
• At least 5 years of clinical operations experience, including ≥1 year of independent project management experience. Oncology monitoring/management, IIT project management, or rare disease project management experience is highly preferred.
• Experience as Sr. CRA/LCRA, Assistant Project Manager or Deputy Project Manager in multinational pharma or CRO is preferred.
• Familiar with Chinese clinical trial regulations including those of the Human Genetic Resources Administration and national inspection requirements.
• Project management experience in the U.S., Australia or Europe is preferred.
• Experience in clinical site quality control, third-party auditing or CFDI inspections is preferred.
• Ability to work independently, with willingness to travel, work overtime and across time zones.
• Strong commitment to targets and proactive, results-oriented attitude.
• Excellent verbal and written communication skills in both Chinese and English.