Job Responsibilities:

1.Assess the clinical feasibility and risk profile of new and ongoing R&D projects; provide medical insights for preclinical research of innovative drugs from the perspectives of clinical needs and translational medicine, including participation in biological evaluations during the preclinical phase.

2.Demonstrate proficient knowledge of clinical trial regulations and drug registration requirements; exhibit strong creative thinking and exceptional capabilities in product differentiation analysis and clinical positioning, with a proactive approach to pioneering clinical research in innovative drug development.

3.Participate in shaping the company’s product development strategy; guide team members in defining Target Product Profiles (TPP), clinical development plans, and risk assessment/mitigation plans; oversee key development milestones, evaluate project progress, and minimize product development risks.

4.Lead the team in drafting or reviewing clinical documentation for clinical trial applications (CTA) and marketing authorization applications (MAA) to ensure full compliance with NMPA requirements; oversee the review of clinical trial protocols.

5.Direct the team in periodically reviewing and updating product information, Investigator’s Brochures (IB), clinical trial protocols, and other relevant documents; provide ongoing training to the clinical team.

6.Evaluate, select, and manage relationships with domestic and international clinical research sites, investigators, and CROs; organize and chair medical meetings related to R&D activities, such as protocol discussion meetings and advisory board meetings.

7.Guide the team in collecting, processing, and analyzing efficacy and safety data during clinical trials, providing evidence-based support for clinical decision-making.

8.Contribute to the post-marketing lifecycle management of new products; provide clinical support and strategic recommendations for promotional activities led by the Medical Marketing Department.

9.Oversee the team in medical coding, medical query resolution, and review of Serious Adverse Events (SAEs); ensure the proper maintenance of the pharmacovigilance system.

10.Be responsible for the recruitment, development, performance management, and team building of the medical department staff; participate in departmental budget planning.

11.Establish and maintain a network of key opinion leaders (KOLs) in relevant therapeutic areas.

12.Ensure the confidentiality of R&D projects, technologies, and data within the department.

Job Requirements:

1.Doctoral degree (MD or PhD) in Clinical Medicine.

2.Minimum of 10 years of clinical research experience in new drug development, including at least 5 years in a team management role. Candidates with a background in gastroenterology or proctology, and/or experience with multinational pharmaceutical companies, are strongly preferred.

3.Solid knowledge base in medicine, data management and statistics, drug registration, and clinical pharmacology.

4.Excellent command of English, both written and spoken; proficient in Microsoft Office Suite, with strong PowerPoint presentation skills.

5.Demonstrated leadership and innovation; strong sense of responsibility and resilience under pressure; willing and able to travel frequently on business.