Careers
Careers
As an innovative R&D enterprise, Usynova always encourages its employees to be bold in making innovations and forge ahead with courage.
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Open Positions
Clinical Research Associate II (CRA II)
Clinical Research Associate II (CRA II)
Job Description:
1.Site Management:‌ - Oversee site selection, initiation, monitoring, and closure (onsite/remote) to ensure protocol/GCP compliance. - Conduct regular site visits to verify data accuracy, integrity, and regulatory adherence. 2.‌Documentation:‌ - Review/maintain trial documents (informed consent forms, CRFs, drug logs) and ensure site file completeness. 3.‌Coordination:‌ - Serve as primary liaison between sites and project teams, resolving operational issues. - Collaborate with internal teams (data management, drug safety, statistics) to ensure trial smooth execution. 4.‌Quality Control:‌ - Identify/report deviations, implement CAPAs, and safeguard data integrity per regulatory standards. 5.Training & Support:‌ - Deliver GCP/protocol training to site staff. 6.‌Reporting:‌ - Generate monitoring reports and follow-up letters; regularly update project teams on progress/risks.
Qualifications:
1.Education:‌ - Bachelor's degree or higher in medicine, nursing, pharmacy, or related biomedical fields. 2.‌Experience:‌ - Minimum 2 years of CRA experience; CRA II level preferred. - Experience in autoimmune/dermatology trials or international multicenter studies is advantageous. 3.‌Regulatory Knowledge:‌ - Proficient in ICH-GCP guidelines and clinical SOPs. 4.Technical Skills:‌ - Competent in Office software (Word, Excel, PowerPoint) and clinical trial tools (EDC, CTMS). 5.‌Language:‌ - Strong English reading/writing skills for document review and preparation. 6.‌Soft Skills:‌ - Excellent communication, coordination, and problem-solving abilities for cross-functional collaboration. 7.‌Other Requirements:‌ - Willingness to undertake frequent domestic/international travel. Location:‌ Shanghai, China
Clinical Project Manager
Clinical Project Manager
Job Description:
1.Project Management:‌ - Lead overall planning, execution, and monitoring of clinical trials to ensure on-time delivery. - Develop project timelines, budgets, and resource allocation plans with continuous progress tracking. - Identify risks, implement mitigation strategies, and resolve operational issues promptly. 2.‌Cross-functional Collaboration:‌ - Manage multidisciplinary teams and coordinate internal/external resources (e.g., CROs, sites, vendors) to achieve project objectives. 3.‌Quality Assurance:‌ - Ensure compliance with GCP, ICH guidelines, and regulatory requirements. - Oversee data integrity, accuracy, and adherence to protocols. 4.‌Documentation:‌ - Lead writing/reviewing clinical documents (protocols, IB, CSR, DSUR) and maintain timely updates/archiving. 5.‌Financial & Contract Management:‌ - Manage trial budgets, track expenditures, and negotiate contracts to protect company interests. 6.‌Communication:‌ - Provide regular risk/progress reports to leadership and facilitate stakeholder meetings.
Qualifications:
1.Education:‌ - Bachelor's degree or higher in medicine, pharmacy, life sciences, or related fields (preferred). 2.Experience:‌ - Minimum 3 years of clinical trial project management experience. - Experience in autoimmune/dermatology trials or global multicenter trials is advantageous. - Comprehensive knowledge of clinical trial lifecycle (initiation, execution, monitoring, close-out). 3.Skills:‌ - Expertise in GCP, ICH guidelines, and regulatory requirements. - Strong multitasking and leadership abilities. - Proficiency in project management tools (e.g., Microsoft Project, Excel). Location:‌ Shanghai, China
Clinical Medical Manager
Clinical Medical Manager
Job Description:
1.Responsible for writing, reviewing, and revising clinical trial protocols, Investigator Brochures (IB), Case Report Forms (CRFs), informed consent forms, patient diary cards, and other related documents. 2.Lead the writing, review, and revision of clinical study reports (CSRs) and clinical overviews, and assist with IND submissions. 3.Provide medical support in project development, market research, and clinical strategy formulation, including internal/external medical communication and training. 4.Offer medical support across all stages of drug development projects, including but not limited to: a.Communicate with clinical medical experts regarding clinical trial design as needed. b. Participate in clinical protocol discussion and summary meetings as a speaker, review meeting minutes, and provide academic support. c.Conduct medical monitoring at the study level, including eligibility/recruitment audits and protocol deviation reviews. d.Engage in clinical trial initiation, patient eligibility reviews, medical monitoring, document writing/reviewing, and maintain professional communication with internal/external experts. e.Collect, record, analyze, and report trial safety data, chair safety review meetings, and communicate safety findings with experts. f.Review and revise SAE (Serious Adverse Event) and DSUR (Development Safety Update Report) submissions. 5.Establish and oversee company drug safety policies and management systems. 6.Perform other duties assigned by leadership.
Qualifications:
1.Master's degree or higher in clinical medicine or related fields; background in autoimmune diseases/dermatology preferred. 2.3+ years of medical/medical monitoring experience; biopharmaceutical/innovative drug experience preferred. 3.Deep understanding of clinical trial regulations/guidelines and disease-specific clinical guidelines (e.g., autoimmune/dermatology). 4.Strong literature research, writing, and presentation skills in English/Chinese. 5.Proficient in office software; statistical analysis skills a plus. 6.Highly responsible, ethical, resilient, with excellent organizational/communication skills. 7.Willingness to travel. Location:‌ Shanghai, China
Small-Molecule Scientist
Small-Molecule Scientist
Job Description:
1.Conduct innovative molecule design and synthesis, as well as lead compound optimization under the supervision of the team leader. 2.Collaborate with the biology team to research and identify drug candidates. 3.Manage and coordinate CRO teams for drug synthesis. 4.Assist the clinical team in preparing relevant regulatory submission materials.
Qualifications:
1.Bachelor's or Master's degree in Organic Chemistry, Medicinal Chemistry, or related fields. - Bachelor's degree holders should have 3-5 years of synthesis experience. - Master's degree holders should have 2-3 years of synthesis experience. 2.Strong theoretical foundation in organic chemistry, biology, and medicinal chemistry, with extensive hands-on experience in synthetic chemistry. 3.Proactive, meticulous, accountable, analytical thinker, quick learner, team player, and highly adaptable to the dynamic environment of a startup company. 4.Prior experience in innovative drug development is preferred. Location:‌ Shanghai, China