AbbVie Clinical Lead, Immunology in Shanghai, China
Clinical Lead, Immunology
China, Shanghai, Shanghai
Research & Development
This position represents frontline scientific expertise for assigned AbbVie immunology pipeline clinical development in China. Provides clinical science insights on portfolio assessment, developmental strategy plan, protocol discussion, trial quality and safety oversight (phase I to phase III), registration approval, and life cycle management. Coaching Junior CRP. Support TA Lead for achieving the scientific goals with quality evidence and thoughts; establishes scientific partnerships with China academia. The position works with Global & JAPAC development teams, SM&M, Regulatory Affairs, Medical Affairs, and Commercial Development, to: 1) identify unmet medical needs, 2) propose development strategies and clinical pathways for new compound registration in China, 3) do protocol discussion from China, 4) ensure study level safety and quality with SM&M and investigators during the trial conduct.
Responsible for China development strategies proposing and clinical pathways for new compound registrations in China.
As local study physician provide medical support at study level, cover phase I to phase III.
Responsible for medical part in protocol, IV meeting, medical monitor during study ongoing, CSR/ China CSR, site report work.
Responsible for new compound and indication evaluation and prioritizing China, including opportunities for alliances and partnerships. Provides China scientific inputs to the global TPP.
Provides China clinical expertise to global design clinical development plans and protocol discussion, ensuring the study design meeting the local medical practice and regulatory requirements to support NDA registration.
Responsible for initiates proper medical activities, i.e. medical surveys, Ad Board meetings, KOL visits and other insights development, to support clinical plan formation and execution.
Works closely with Regulatory Affairs for figuring out efficient pathway for registration, based on clinical expertise from CTA through NDA approval.
Establishes scientific partnership with Chinese academia, key opinion leader, investigator, key study centers for effective planning and high-quality implementation in China.
Provides medical/scientific training on program specific standards to SM&M and investigators to ensure consistency through the process of design, conduct and reporting of clinical trials.
Ensures seamless communication and handover to medical affairs of approved indications and support launch activities.
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.
Coaching Jr CRP. Provide support and training to team.
Affiliate: RA, Commercial Development, SM&M, Market Access, Medical Affairs, Public Affairs
JAPAC R&D and NPI members
Global ADT members
Chinese academia, KOL, PI
Medical Degree with China clinical doctor license, Ph.D is plus.
With strong medical background of Clinical immunology, have 5 years clinical practice experience in hospital, Department of rheumatology (preferred), nephrology, internal medicine.
Adequate knowledge of the drug development process and the regulatory framework for clinical development. Working experiences (> 4 years) in clinical development group of pharmaceutical (or biopharmaceutical) company or equivalent clinical practice is essential.
Clear understanding of the developmental program interplay among Regulatory Affairs, Clinical Development and Commercial objectives. Experienced in leading multiple, diverse clinical development programs. Clinical development experience in multiple area, such as rheumatology, dermatology, gastroenterology etc area. Experience in phase I-phase III study.
Familiar with China regulatory policy and lead China compound development strategy. Co-work with cross-function on new compound/indication evaluation.
Strong insights to study design, good knowledge of medical monitor, data collection, management, analysis, and interpretation are required.
Strong verbal and written communication skills. Fluent English.
Effective collaboration with peers, stakeholders and partners to achieve positive impact to development results.
Strong commitment to be compliant with all the relevant rules and procedures, and to scientific quality and integrity.
Job Type: Experienced
Job Level Code: M