Biogen seeks a Clinical Development Lead to drive its China strategy for assigned programs, collaborating with global and Chinese teams to prioritize the portfolio and ensure alignment with a global strategy. This involves strategic planning, execution, interpretation, and submission of pivotal clinical studies. The role requires leadership, scientific expertise, and strong communication skills to navigate a complex environment.
Biogen is looking for a dynamic Clinical Development Lead to champion its China strategy for assigned programs. This role involves collaborating closely with global product teams and Chinese affiliate cross-functional teams to prioritize the Biogen portfolio within the Chinese market.
This entails ensuring alignment with an integrated global strategy, encompassing the strategic design, execution, interpretation, and submission dossier review of pivotal clinical studies supporting high-priority programs. \The Clinical Development Lead will engage with cross-functional teams at Biogen and external stakeholders, including the R&D Development Asset Team (DAT), Study Management Team (SMT), and Chinese cross-functional teams. This role requires delivering strategic leadership for study teams, integrating local knowledge in disease areas, medical communities, commercial operations, research, and regulatory landscapes to create a robust strategic framework and plan for the Chinese market. \ The successful candidate will provide clinical oversight across all relevant studies and programs in China. Responsibilities include ensuring smooth study preparation and execution, conduct ongoing medical data review to guarantee data integrity, and review and interpret study data. The role demands scientific input and contribution to creating vital clinical deliverables, such as clinical trial protocols, Clinical Study Reports (CSRs), and submission summary/regulatory response documents. Maintaining high quality, accuracy, and consistency with overall program goals and the China Development Plan (CDP) is crucial. Building relationships with Key Medical Experts (KMEs) and external specialists to gather, review, analyze, and communicate scientific and medical knowledge essential for clinical development is also critical. Communication with the China Drug Enforcement agency (CDE), representing Biogen and patient interests, and timely escalation of matters to appropriate internal partners and stakeholders are integral to this role
Clinical Development China Strategy Clinical Research Drug Development CNS Immunology
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