Shanghai Head Of TA Non Onco,ExpMED China Chin

Job description

About Innovation Unit China Innovation Unit China (China R&D Center) is a strategic innovation hub within Boehringer Ingelheim’s global R&D network, established to harness China’s rapidly evolving scientific capabilities and vibrant innovation ecosystem. By integrating Experimental Medicine, External Innovation, Development CMC, and Clinical Pharmacology & Non-clinical Safety Science, IU China connects promising science with early development expertise to accelerate high-potential opportunities, contribute to the global pipeline, and help accelerate breakthrough therapies for patients in China and around the world. Responsibilities - TA Strategy & Portfolio Contribution(INFL, CRM, EH&MH) 1)Define and execute the ExpMED China strategy for the non-ONC TAs, aligned with the global ExpMED TA strategies, the ExpMED China / IU strategy and portfolio priorities (Simplify – Focus – Accelerate). 2)Ensure China participation in global CS-to-PoC programs of the non-ONC TAs (default model: join global programs with China focus to accelerate enrollment speed and decision quality); for selected non-ONC assets (e.g., INFL, advanced modalities), shape China-led / China-first components from protocol design and dose escalation onward. 3)Bring the China perspective (medical practice, patient populations, regulatory requirements, competitive landscape) into global non-ONC early clinical development plans and governance; propose China-enabled acceleration options per asset. 4)Prioritize resources across TAs and programs according to portfolio value and ExpMED China priorities. -Scientific & Clinical Leadership 1)Provide medical-scientific leadership for the design, conduct and interpretation of non-ONC CS-to-PoC studies with China participation; ensure scientific rigor, patient safety and compliance with ICH-GCP and NMPA/CDE requirements. 2)Review and approve China-relevant protocols and amendments, study documents, clinical sections of regulatory submissions, data interpretations and publications within delegated authority. 3)Enable timely, high-quality PoC and governance decisions for China-supported non-ONC programs within global governance frameworks. 4)Maintain deep knowledge of emerging science, standard of care and competitor activity in China across INFL, CRM and EH&MH. -China Evidence Generation & Translational Science 1)Ensure generation of China-specific clinical, translational and biomarker evidence in the non-ONC TAs that supports global development, China regulatory (NMPA/CDE) and value strategies. 2)Partner with Clinical Pharmacology & Non-clinical Safety Sciences (CPS), Translational Medicine / Biomarker and Data & Analysis functions to integrate China data (e.g., PK/PD, ethnic sensitivity, biomarkers) into global programs; ensure compliant handling of human genetic resources and data. -Clinical Network, External Engagement & BD&L Support 1)Build and sustain a dedicated network of early clinical investigators, Phase I units and specialty sites with INFL, CRM and EH&MH expertise across China; together with Clinical Operations, establish efficient early clinical development processes with these partners. 2)Represent ExpMED China externally to key opinion leaders, academic institutions, biotech partners and CROs in the non-ONC TAs; support health authority interactions together with Regulatory Affairs. 3)Provide ExpMED clinical assessment of China-sourced non-ONC external innovation and licensing opportunities in support of the External Innovation / BD&L strategy of the China R&D Center. -Team & Talent Leadership 1 ） Build, lead and retain a high-performing non-ONC TA team within ExpMED China [team size and direct/matrix reporting of e.g. Clinical Development Experts, Clinical Trial Execution Experts, Safety Physicians, Biomarker Experts and Statisticians to be confirmed per final ExpMED China structure], including colleagues holding global roles in programs of strategic relevance; set clear objectives and ensure delivery. 2 ） Develop talent and succession for the non-ONC TAs in China and support cross-border mobility and capability exchange with global ExpMED. 3 ） Foster an inclusive, high-accountability culture of open communication, compliance, scientific excellence and the experimental mindset, aligned with Our Behaviors. -Matrix & Cross-Functional Collaboration 1 ） Act as the primary China counterpart of the global ExpMED TA Heads for INFL, CRM and EH&MH and their teams; ensure one-voice alignment between global TA strategy and China execution. 2 ） Partner with the ExpMED China Clinical Operations, Data & Analysis and Quality / Biomarker / Regulatory Support functions; with CPS, Development CMC and External Innovation within the China R&D Center; with Safety Science / Pharmacovigilance, Regulatory Affairs China, Biostatistics and the Development TA teams; and with the China Human Pharma Business Unit / Medical Affairs. 3 ） Participate in and contribute to relevant global and local governance forums within defined decision thresholds. -Governance, Compliance & Quality 1 ） Ensure full compliance with global SOPs, GxP / ICH-GCP, quality standards and ethical requirements, while adapting execution to Chinese regulatory realities (NMPA/CDE, Human Genetic Resources regulations, data protection, ethics committees). 2 ） Proactively identify, manage and escalate scientific, operational and compliance risks in non-ONC China programs. Qualifications Experience: • ≥ 10 years of combined experience across hospital, academic and industry settings in clinical development, with significant experience in Experimental Medicine / early clinical development and a track record of driving programs to PoC. • Leadership experience in complex, matrixed R&D environments, including leading teams of clinical scientists / physicians. • Demonstrated experience working in or with China-based R&D and clinical ecosystems, including an established network with investigators and Phase I / specialty sites; experience in more than one non-Oncology TA is a plus. Skills & competencies: • Scientific expertise: deep understanding of disease biology, early clinical trial design and translational medicine. • Strategic thinking: ability to translate global strategy into China execution plans and to prioritize across TAs. • Leadership: inspires and develops multidisciplinary teams; builds capability and succession. • Communication and influence: excellent ability to engage and influence senior internal and external stakeholders across cultures; business fluency in English and Mandarin Chinese. • Regulatory knowledge: working knowledge of ICH-GCP, NMPA/CDE requirements, China Human Genetic Resources regulations and global drug development. • Compliance and risk mindset: strong local compliance culture; proactive risk identification and escalation. • Innovation and agility: track record of implementing novel approaches in early clinical development; thrives in a fast-paced, ambiguous environment. 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