About the Company

• Our client is an innovative biotechnology company focused on the discovery and development of differentiated therapies for autoimmune and immune-mediated diseases.
• With a strong commitment to scientific excellence and clinical innovation, the company is advancing a pipeline of novel therapeutics aimed at addressing significant unmet medical needs in rheumatology, neurology, and related immunology fields.
• The organization offers a highly collaborative environment where clinical, regulatory, and scientific teams work closely to accelerate early-stage development and bring transformative therapies to patients.

About the Job

 Medical Director, Clinical Development (Autoimmune Diseases)
Location: Shanghai or Nanjing, China

• Lead the medical assessment of potential therapeutic indications based on corporate strategy, product characteristics, disease biology, and competitive landscape analysis.
• Contribute to the development of integrated medical strategies and corresponding clinical development plans for early-stage drug programs.
• Provide medical leadership in the design and execution of clinical development programs, including study concepts, protocols, and development pathways.
• Collaborate with investigators, CROs, vendors, regulatory authorities, and other external stakeholders to support study design, clinical trial execution, and registration strategy.
• Participate in or lead discussions regarding clinical trial initiation plans, regulatory interactions, and product development milestones.
• Author, review, and provide medical oversight for key clinical documents, including clinical study protocols, investigator brochures, clinical study reports, informed consent forms, and other development-related materials.
• Establish and oversee medical monitoring strategies across clinical studies to ensure participant safety, data integrity, and scientific rigor.
• Conduct ongoing medical review and interpretation of clinical trial data and provide recommendations to cross-functional project teams.
• Support the preparation and review of scientific publications, abstracts, presentations, and other academic outputs arising from clinical programs.
• Collaborate closely with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Translational Medicine teams to ensure alignment throughout the development process.
• Contribute to the development, implementation, and continuous improvement of medical and clinical development SOPs, working procedures, and training programs.
• Stay informed on emerging scientific advances, treatment paradigms, and competitive developments within autoimmune and neuroimmunology therapeutic areas.
• Perform additional responsibilities as assigned to support corporate and pipeline development objectives.

Required Qualifications

• MD, Master's Degree, or higher in Clinical Medicine; specialization in Rheumatology, Neurology, or autoimmune diseases is strongly preferred.
• Minimum of 5 years of clinical practice experience as a physician.
• At least 3 years of experience in early-stage drug development within the biotechnology, pharmaceutical, or clinical research industry.
• Solid understanding of clinical development processes from early clinical research through regulatory submission.
• Strong knowledge of GCP, ICH guidelines, and applicable clinical trial regulations in China and globally.
• Demonstrated experience in clinical protocol development, study design, and medical monitoring activities.
• Proven capability in authoring and reviewing high-quality medical and scientific documents.
• Strong literature evaluation and medical research skills, with the ability to critically interpret scientific and clinical data.
• Experience working with investigators, key opinion leaders (KOLs), CROs, and regulatory agencies is highly desirable.
• Excellent analytical thinking, communication, and cross-functional collaboration skills.
• Ability to work effectively in a dynamic biotech environment and manage multiple priorities simultaneously.
• Professional working proficiency in English, with strong written and verbal communication abilities.

Why This Opportunity?

• Join a clinically focused biotechnology organization developing innovative therapies in high-priority autoimmune disease areas.
• Play a strategic role in shaping clinical development programs from early-stage research through key regulatory milestones.
• Work directly with experienced scientific and executive leadership teams in a fast-growing, innovation-driven environment.
• Gain broad exposure across clinical strategy, regulatory interactions, medical monitoring, and scientific communications.
• Opportunity to make a meaningful impact on the development of novel treatments for patients with significant unmet medical needs.