Job Description

Associate Director, Clinical Research China Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important missions of clinical research in China is to shorten the gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of assigned program(s) for developing local registration strategy, engaging key opinion leaders, developing study protocol, drafting study report, and preparing dossier for regulatory submission. As Clinical Lead in the oncology China Product Development Team, the clinical research physician will play a key leadership role for clinical development in China. This individual will be responsible and accountable for the development of the best China development plan. The clinical research physician partners closely with the headquarters project development team, China regulatory affairs, medical affairs, project management, clinical trial operations, and the commercial team for flawless planning and execution of the China registration strategy. This individual is expected to be responsible for different programs across the therapeutic franchise. This individual will serve as the key interface between the headquarters project development team and the China development center. The clinical research physician is expected to abstract high-level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician will represent the clinical development team of the China development center on the HQ project team as needed and is expected to address issues/questions raised by the HQ team and provide feedback to the HQ project team from the China perspective. This individual should have excellent communication skills with demonstrated language skills in both written and verbal English and Chinese. Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high-quality clinical study protocol. We place high value on efficiency, feasibility, desirable labels, and cost-effectiveness, necessitating careful collaboration with operational experts such as colleagues from global clinical trial operations. The clinical monitor will interpret, prepare clinical study reports, regulatory dossiers, regulatory responses, and review product labels. The clinical research physician will also prepare and review manuscripts for publication. In this role, this individual will work with the study team to ensure safety/efficacy information is adequately captured and review serious adverse events. The clinical research physician will review and approve monitoring plans/reports/data listings. The clinical research physician will also work as a clinical scientist, to lead lab selection and clinical supply application during the study planning phase, provide scientific inputs to EC review, HGRAC review, and investigator meetings during the study initiation phase, and review protocol deviations and answer protocol-related questions during the study implementation phase. To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders (KOLs) and internal key stakeholders such as medical affairs, marketing, and regulatory affairs. The clinical physician will be involved in introducing new compounds in development to China KOLs and seek feedback for our clinical development plan as needed. The clinical research physician will participate in due diligence evaluation as an expert for medical-related matters. The clinical physician is also working closely with medical affairs to identify gaps/opportunities in patient care in China and develop clinical plans/studies to capitalize on emerging opportunities. The clinical research physician in China will report directly to the Director of Clinical Research in the China Development Center. Other key points of contact in the organization will include emerging market development colleagues in the US, project teams in the US, regulatory affairs colleagues in China, medical affairs, project management, and clinical trial operations. #J-18808-Ljbffr MSD Malaysia

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