China Development Head

Responsibilities

Lead the clinical development strategy for innovative drugs in the autoimmune disease field; screen indications, design development pathways, formulate key clinical study protocols, and assess development risks based on product characteristics and clinical needs.
Oversee the medical design and review of key clinical study protocols; participate in medical decision-making during clinical trial execution, including safety assessments, efficacy data interpretation, and key milestone decisions.
Participate in formulating regulatory strategies; lead the team in preparing new drug application materials and engaging with regulatory authorities across activities such as advisory meetings, review meetings, and on-site inspections with the NMPA (National Medical Products Administration).
Internally, build and manage the medical team; externally, establish and maintain communication with experts, clinical investigators, and partners to foster mutual trust and strong collaborative relationships.
Participate closely in cross-departmental collaboration with early R&D, manufacturing, marketing, and other teams; provide professional medical guidance and support the full-cycle advancement of products from R&D through partnerships to market launch.
Stay current with industry trends; closely monitor advances in basic and clinical research in the autoimmune disease field; assess trends in the field and provide recommendations for the company's product pipeline strategy.

Doctoral degree in a clinically related discipline; 8+ years of experience in innovative drug clinical development; familiarity with drug development processes, relevant regulatory requirements for conducting clinical trials, and GCP (Good Clinical Practice).
Familiarity with the development of innovative biologics drugs in the autoimmune disease field; full-cycle experience in Phase 1-2 clinical trials with a track record of leading early-stage clinical development strategies. Candidates with clinical experience or drug development experience in rheumatology/immunology, respiratory, allergy, dermatology, or nephrology are preferred.
Excellent communication and teamwork skills; rigorous work ethic; strong scientific research competence.
Fluent in English with proficiency in reading medical literature, academic communication, and international conference engagement. Experience at multinational pharmaceutical companies is preferred.
Strict adherence to company policies and applicable laws and regulations.