Director

I. Key Responsibilities

1. Strategic Planning & System Development

• Establish and optimize the institute’s R&D management systems, including project management, IP management, registration affairs, and R&D quality control systems.
• Lead process R&D for Active Pharmaceutical Ingredients (API) and formulations, as well as quality research and Consistency Evaluation (CE), ensuring compliance with NMPA, FDA, EMA, and other global regulatory standards.

2. Innovative R&D & Technological Advancement

• Lead teams in the development of small-molecule New Chemical Entities (NCEs), high-end generics, and 505(b)(2) drugs.
• Spearhead technical breakthroughs in complex formulations (e.g., sustained/controlled release, microspheres, liposomes) and specialty APIs, driving successful tech-transfer to manufacturing.
• Monitor global pharmaceutical frontiers and promote the application of advanced technologies such as green chemistry, continuous flow reaction, and biocatalysis.

3. Team Leadership & Talent Development

• Oversee organizational structure design, recruit high-level R&D talent (domestic and overseas), and build an internationally competitive R&D team.
• Establish scientific performance evaluation and incentive mechanisms to cultivate core technical backbones and enhance overall R&D efficiency.
• Manage the annual R&D budget, optimizing resource allocation to control costs while maximizing output.

4. External Collaboration & Registration Affairs

• Develop regulatory strategies and serve as the primary liaison with regulatory agencies (e.g., CDE/NMPA) to ensure smooth approval processes.
• Expand strategic partnerships with universities, research institutes, and CROs to build an open innovation ecosystem.
• Lead the application and execution of major government science and technology projects (e.g., National "Major New Drug Innovation" Programs).

II. Qualifications

1. Education

• Ph.D. in Medicinal Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Engineering, or related fields.
• Postdoctoral experience or overseas R&D experience in renowned pharmaceutical companies/institutions is highly preferred.

2. Experience

• 10+ years of experience in pharmaceutical R&D; 10+ years in R&D management/leadership roles.
• Demonstrated success in leading at least 2 products through the full lifecycle from IND to NDA/BLA approval.

3. Professional Competencies

• Technical Expertise: Proficient in synthetic route design, process optimization (DOE), analytical method development/validation, and formulation studies.
• Regulatory Mastery: Deep understanding of ICH guidelines, China GMP, and EU/US cGMP regulations; extensive experience in CTD dossier compilation and regulatory communication.