（高级）总监，医学（IBD）

Position Summary

The Medical Director/Senior Medical Director, Clinical Development will be responsible for clinical development of Gastroenterology assets, with a focus on Inflammatory Bowel Disease (IBD), including Ulcerative Colitis (UC) and Crohn's Disease (CD). This role will lead clinical development strategy, protocol design, medical monitoring, regulatory interactions, and cross-functional execution, and will support BD medical due diligence and clinical value assessment for external opportunities.

Key Responsibilities

1. Clinical Development Strategy

· Lead clinical development strategy and Clinical Development Plan (CDP) for Gastroenterology/IBD assets.

· Develop integrated evidence generation plans to support registration and commercialization.

· Evaluate global and China regulatory pathways and ensure alignment with corporate strategy.

· Identify key development risks and propose mitigation plans.

2. Clinical Trial Design & Execution

· Lead protocol development and review for Phase I-III clinical studies.

· Define study population, key eligibility criteria, endpoints, biomarkers, and statistical considerations.

· Serve as medical monitor for global and/or regional clinical trials.

· Participate in study execution, medical review, data interpretation, and safety monitoring.

· Review and contribute to clinical study reports (CSR), investigator brochures (IB), and regulatory documents.

3. Regulatory Interactions

· Collaborate with Regulatory Affairs for IND, CTA, NDA/BLA and other submission activities.

· Support interactions with NMPA/CDE, FDA, EMA and other health authorities as needed.

· Participate in regulatory consultation meetings and inspection readiness activities.

· Lead medical responses to regulatory questions.

4. External Scientific Engagement

· Build and maintain relationships with KOLs, investigators, academic societies, and research networks.

· Capture clinical insights to support development strategy and study design.

· Represent the company at scientific congresses, advisory boards, and investigator meetings.

5. Cross-functional Leadership

· Collaborate closely with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Commercial, and Business Development teams.

· Drive project execution, cross-functional alignment, and timely decision-making across the development lifecycle.

6. Business Development Support

· Conduct medical due diligence for external opportunities in Gastroenterology/IBD and related therapeutic areas.

· Assess clinical differentiation, competitive landscape, unmet medical need, and development feasibility.

· Provide clinical and regulatory assessment to support licensing or acquisition decisions.

Qualifications

Education

· Required: MD, PharmD, PhD or equivalent advanced degree in Medicine, Gastroenterology, Immunology, Clinical

Pharmacology, or related fields.

· Preferred: PhD and/or physician background with direct clinical practice experience.

Experience

· Minimum 8 years of pharmaceutical or biotechnology clinical development experience.

· Experience across global and/or China clinical development, preferably from IND/CTA through NDA/BLA.

· Hands-on experience in protocol development, medical monitoring, regulatory interactions, and clinical strategy

development.

· Direct IBD development experience is strongly preferred, including Ulcerative Colitis, Crohn's Disease, or other immune-mediated gastrointestinal diseases.

· Experience in both multinational pharmaceutical companies and leading Chinese biopharmaceutical companies is preferred.

Technical Competencies

· Strong understanding of IBD disease biology, gastrointestinal clinical practice, and evolving treatment

landscape.

· Solid knowledge of global IBD clinical development standards and China/global regulatory requirements.

· Expertise in clinical trial design, endpoint selection, benefit-risk assessment, and clinical data

interpretation.

· Experience with biologics and/or advanced immune-modulating therapies, such as TNF inhibitors, IL-23 inhibitors, JAK inhibitors, S1P modulators, and integrin-targeting therapies, is highly desirable.

· Experience with global development programs and MRCT studies is highly desirable.

Leadership & Communication

· Strategic mindset with strong scientific judgment and ownership mentality.

· Strong project leadership, stakeholder management, and matrix collaboration capability.

· Excellent written and verbal communication skills in both Chinese and English.

· Able to communicate effectively with global partners, investigators, KOLs, and regulatory agencies.