Clinical Scientist

HUYABIO™ is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® the company’s first commercial product is marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

Job Summary

Reporting into HUYABIO’s Global Head of Research and Development, the Clinical Scientist provides scientific expertise necessary to design, advance and deliver clinical studies and programs within the pipeline. This individual will be responsible for the design and execution of his/her clinical trials activities, working closely with clinical operations team members to execute activities associated with trial conduct.

This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYABIO functional areas and its global office sites is essential.

Primary Duties and Responsibilities

• Perform clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, working cross-functionally to monitor clinical data
• Contribute to the development of Data Review Plan and Data Review Strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study, and across countries and sites
• Work to improve the quality of reviews/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
• Collaborate with Data Management/Programming to ensure CRF design adequately supports data collection in alignment with the clinical trial protocols
• Collaborate cross-functionally to develop essential clinical trial documents such as protocols, ICF documents/amendments, CRF’s, CSRs, and Investigator Brochures
• Contribute by authoring/reviewing clinical portions of Regulatory Documents to include; Pre-IND, IND, IB, DSUR, PSUR, IRB responses, etc for successful regulatory submissions
• Support ad-hoc Regulatory activities, such as preparation and conduct of meetings with regulatory agencies
• Conduct literature review; review clinical narratives
• Participate in the development of site and CRA training materials and present these at SIV’s and/or Investigator Meetings

Job Qualifications and Requirements

• Advanced degree in Life Sciences (PhD, PharmD) required
• 2+ years of experience within clinical research, clinical development or clinical science within a biotechnology or pharmaceutical setting
• Knowledge of Oncology drug development and clinical trial processes, study design, statistics and clinical operations within a similar biotech and/or pharmaceutical environment
• Skills to support program-specific data review and trend analysis
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Knowledge of GCP and regulatory requirements for the conduct of Oncology clinical trials
• Ability to critically evaluate data, literature and presentations
• Ability to lead and work with cross-functional teams
• Strong project management skills