Role Summary:
The Development China Clinician is responsible for high quality and timely delivery of one or more interventional clinical trials for a Global Product Development/Sponsor Essential Health (PEH). They apply technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies (in partnership with Development Operations) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). They ensure compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues.
The China Clinician may act as a site liaison and point of contact to expedite study start-up and conduct and to support clinical training, compliance and overall study quality.
Technical/Behavioral Competencies:
61 Demonstrated potential or ability to design, initiate, and conduct clinical studies in industry, academic, or research clinic settings.
61 Proven scientific writing skills, with strong interpersonal, written/verbal communication skills, including the ability to evaluate, interpret, and present complex data.
61 Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents.
61 Able to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/or from other disciplines.
61 Collaborative problem solving (handles conflict constructively).
61 Creativity and/or ability to put innovative approaches into practice in clinical development.
61 Able to embody Sponsor leader behaviors and the OWN-IT culture.
61 Able to anticipate issues related to operational feasibility, recruitment challenges, able to discuss investigator performance issues, coach and/or mentor clinical investigative site staff to achieve operational and recruitment goals and quality standards.
61 Able to place innovative approaches into action that focus on trial execution and site performance.
Qualifications (Training, Education & Prior Experience):
Education
61 Required: BA/BS or equivalent qualification.
61 Preferred: M.D., Ph.D., D.V.M., M.S., and/or Pharm.D. or equivalent qualifications. Postgraduate training/certification/fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g., doctoral thesis, publications, research reports, etc.).
Experience
61 Preferred: Thorough understanding of local/international regulations applicable to clinical trials (pre and post approval). Practical experience in clinical trial strategies, methods, and processes. Track record of design, oversight, and interpretation of clinical studies. Previous leadership/management experience or training.
61 Required: Knowledge and experience in Good Clinical Practices. Experience in conduct and execution of clinical trials, including operational feasibility, recruitment, investigator performance, investigative site relations.