Clinical Research Physician
Abbvie INC · 🌍 Shanghai, Shanghai, CN
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About the role
PURPOSE STATEMENT: Clinical Research Physician represents frontline scientific expertise for assigned AbbVie TA development in China. Provides clinical science insights on portfolio assessment, developmental plan formation, protocol discussion, trial quality and safety oversight, registration approval, and life cycle management. Supports decision of TA Science Lead for achieving the scientific goals with quality evidence and thoughts; establishes scientific partnerships with China academia. Within TA areas, the position works with Global & JAPAC development teams, Clinical Development Operations (CDO), Regulatory Affairs, Medical Affairs, and Commercial Development, to: 1) identify unmet medical needs for related TA development assets, 2) lead China local development project team to propose development strategies and clinical pathways for new compound registration in China, 3) participate protocol discussion from China, 4) ensure study level safety and quality with CDO and investigators during the trial conduct, 5) support regulatory submissions. JOB RESPONSIBILITIES: 1. Supports the TA Head and Global TA Science Lead, proposes development strategies and clinical pathways for new compound registrations in China. 2. Acts as China Local Development Project Lead to assess new trial opportunities. Provides scientific expertise in prioritizing diseases and compounds for China, including opportunities for alliances and partnerships. Provides China scientific inputs to the global TPP. 3. Provides China clinical expertise to design clinical development plans and protocol discussion, ensuring the study design meeting the local regulatory requirements, aiming for efficient development tactics for registration. 4. Initiates proper Development-led medical activities, i.e. medical surveys, Ad Board meetings, KOL visits and other insights development, to support clinical development plan formation and execution. 5. Works closely with Regulatory Affairs to develop efficient pathway for registration with scientific justification, generating and reviewing China regulatory filing materials, based on clinical expertise from CTA through NDA approval. 6. Establishes scientific partnership with Chinese academia and key study centers for effective planning and high-quality implementation in China. 7. Provides medical/scientific training on program specific standards to CDO and investigators to ensure consistency through the process of design, conduct and reporting of clinical trials. 8. Provides local medical support to Global study team, including trial medical monitoring, responding to protocol-specific site questions, resolving data queries, and performing analysis to address questions on efficacy and safety etc. 9. Ensures seamless communication and handover to medical affairs of approved indications and support launch activities. 10. Ensures all activities are in compliance with all applicable national laws and regulations, guidelines, codes of conduct, AbbVie's policies, procedures and accepted standards of best practice. KEY INTERFACES: 1. Affiliate: RA, Commercial Development, CDO, Market Access, Medical Affairs, Public Affairs 2. JAPAC R&D and NPI members 3. Global ADT members 4. Chinese academia 5. Regulatory authority 6. Health authority IDEAL CANDIDATE: 1. Medical Degree. With a strong medical background of related TA area, some knowledge of the drug development process and the regulatory framework for clinical development. Working experiences (≥ 3 years) in medical and clinical development group of pharmaceutical (or biopharmaceutical) company or equivalent clinical practice is essential. 2. Understanding of the developmental program interplay among Regulatory Affairs, Clinical Development and Commercial objectives. Experienced in leadin