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The Greater Bay Area International Clinical Trials Center (hereinafter referred to as “the Center”) is a public clinical trial service platform with global impact, established by the Shenzhen Medical Academy of Research and Translation (SMART).
The Center’s establishment is a key initiative aimed at implementing the "Development Plan for the Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone", issued by the State Council (State Document No. [2023] 12). It represents a crucial step in supporting Shenzhen’s efforts to become an international hub for scientific and technological innovation. It is integral to promoting the high-quality growth of the biopharmaceutical industry in the Greater Bay Area. The Center will be strategically located in the Hetao Shenzhen-Hong Kong Cooperation Zone, leveraging the area’s unique geographical and policy advantages. By connecting clinical innovation resources from across the Greater Bay Area and fostering deeper collaboration between Shenzhen and Hong Kong, the Center will establish a one-stop platform for clinical trials. This platform will provide top-tier technical and operational management services to both national and international pharmaceutical and medical device development institutions. Additionally, the Center will play a pioneering role in reforming clinical trial policies and regulations, aligning local practices with international standards. It will also facilitate the creation of a Greater Bay Area biomedical innovation alliance, and increase the region's competitiveness in global biopharmaceutical industry.
In initial phase, the Center will establish five core departments: the Institutional Services and Administrative Office, the Program Development and Methodology Department, the Project Operations and Quality Management Department, the Data and Technology Department, and the Regulatory Affairs Office. These departments will be responsible for providing clinical research services, coordinating research resources, enhancing regional research capabilities, fostering innovation in clinical research, and promoting international cooperation and communication. According to the needs of the Center's construction and operations, SMART is now sincerely recruiting professionals for a variety of employment, including clinical program development, project operations, and data technology. The specific job openings and qualifications are as follows. Specific positions and recruitment conditions are as follows:
1.Director of Program Development & Methodology
(1 position available)
Job Description:
We are hiring a Director of Program Development & Methodology to build and lead the program development and methodology platform for the Center. This role will involve overseeing clinical trial design, statistical analysis, and ensuring timely and high-quality project execution.
Key Responsibilities:
1. Establish and manage the program development and methodology platform.
2. Develop and implement regulatory and operational standards for program development and bio-statistics.
3. Lead training, recruitment, and assessment of departmental personnel.
4. Oversee clinical trial protocol development and statistical analysis.
5. Maintain relationships with industry experts to address complex project issues.
Requirements:
1. 10+ years of experience in project development or methodology within the bio-pharmaceutical or CRO industry.
2. Strong leadership and execution skills, with excellent communication and presentation abilities.
3. PhD degreed in Medicine or Pharmacy.
4. Familiar with domestic and international regulations governing drugs and medical devices development.
5. Fluent in English with the ability to perform duties in an English-speaking environment.
6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
2.Bio-statistician
(Multiple positions available)
Job Description:
We are hiring Bio-statisticians to design and manage statistical plans for clinical research projects. In this role, you will contribute to the development of clinical trial protocols, provide statistical analysis, and manage vendor relationships.
Key Responsibilities:
1. Develop and execute statistical plans for clinical trials, including sample size calculation, randomization, and blinding.
2. Provide statistical support during protocol seminars.
3. Conduct data analysis and review statistical reports.
4. Manage and oversee vendors handling statistical portions of clinical trials.
5. Utilize statistical software (e.g., SAS) for data mining, analysis, and reporting.
6. Participate in academic communication and drug review discussions.
Requirements:
1. Education: Master’s degree or above in Bio-statistics, Medical Statistics or related fields.
2. Experience: 2+ years of experience in clinical trial design and statistical analysis.
3. Skills: Proficient in using statistical software and familiar with domestic and internationalbiostatistical technical guidelines related to clinical trials. With strong logic and responsibility in work
4. Language: Fluent in English Reading and Writing.
3.Director of Regulatory Affairs
(1 position available)
Job Description:
We are hiring a Director of Regulatory Affairs to oversee regulatory compliance for the Center's drug development and registration processes.
This role will involve close tracking of international regulatory updates, providing guidance to internal teams, and maintaining relationships with domestic and international regulatory authorities.
Key Responsibilities:
1. Monitor and interpret regulatory updates from China, the U.S., Europe, and other regions.
2. Provide regulatory guidance to other departments to ensure compliance in drug development and registration.
3. Establish and optimize internal regulatory processes and workflows.
4. Maintain strong relationships with domestic and international regulatory bodies to support policy innovation and approval processes.
Requirements:
1. 10+ years of experience in drug registration and regulatory affairs, with a deep understanding of drug development and international regulatory requirements.
2. Experience of working in international pharmaceutical companies is preferred.
3. Master’s degree in Clinical Medicine, Pharmacy or related fields.
4. Fluent in English with the ability to perform regulatory duties in an English-speaking environment.
5. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
4. Regulatory Affairs Specialist
(Multiple positions available)
Job Description:
We are hiring for meticulous Regulatory Affairs Specialists to manage regulatory submissions and ensure compliance with global regulations.
This role will assist in preparing and submitting regulatory documents and maintain up-to-date knowledge of regulatory changes.
Key Responsibilities:
1. Plan, prepare, and execute regulatory submissions for clinical trials and drug registrations.
2. Compile and submit regulatory documents, ensuring compliance with the latest requirements.
3. Archive and maintain regulatory documents and files.
4. Stay up-to-date with regulatory changes and ensure submission materials are compliant with evolving regulations.
Requirements:
1. Education: Master’s degree in Pharmacy, Medicine or related fields.
2. Experience: 1-3 years of experience in regulatory affairs, preferably within a CRO or pharmaceutical company.
3. Skills: Strong writing and document preparation skills; good understanding of regulatory guidelines.
4. Language: Fluent in both Chinese and English Speaking and Writing.
5. Other: Good at Microsoft Office.
