Qilu Pharmaceuticals

Job Responsibilities:

1. Take overall ownership of formulating comprehensive strategies for Qilu Pharmaceutical's overseas clinical projects, including clinical development pathway planning, trial design optimization, and risk control. Ensure projects meet U.S. market demands and industry standards.
2. Provide end-to-end medical support covering the entire lifecycle of overseas clinical research. Guide the implementation of clinical protocols, data interpretation, and resolution of medical inquiries to guarantee the scientific rigor and compliance of trials.
3. Lead engagement with the FDA and relevant U.S. regulatory authorities. Oversee the overall compilation, submission, and follow-up of clinical registration dossiers to drive the regulatory approval process forward.
4. Establish and maintain collaborative relationships related to overseas clinical research, including partnerships with research sites, CROs/CSOs, and industry experts. Coordinate and resolve cross-departmental/cross-organizational issues during project progression.
5. Monitor the progress, quality, and cost of overseas clinical projects. Conduct regular project reviews, adjust strategies promptly in response to market changes or regulatory requirements, and ensure projects achieve their intended objectives.

Requirements:

1. Hold a Doctor of Medicine (MD) or PhD in pharmaceutical sciences or related fields. Candidates with a U.S. medical license or relevant professional certifications are preferred. Familiarity with the U.S. clinical research system and industry regulations is essential.
2. Possess over 15 years of relevant work experience in U.S. pharmaceutical companies or clinical research organizations, including at least 5 years of experience in overseas clinical project management and strategy formulation. Track record of successfully leading innovative drug projects through FDA registration and approval to market launch is required.
3. In-depth understanding of FDA drug registration and approval processes, regulatory requirements, and guidelines. Ability to independently lead communications with the FDA and effectively address regulatory inquiries and review comments.
4. Exceptional cross-departmental and cross-organizational collaboration capabilities. Proven ability to coordinate resources across research sites, CROs/CSOs, expert teams, and internal departments to efficiently resolve complex issues in clinical project advancement.
5. Strong industry acumen and risk management skills. Ability to adjust clinical strategies based on market dynamics and regulatory changes to ensure project quality, progress, and cost are well-controlled. Excellent verbal and written communication and presentation skills in both English and Chinese are required.
6. Demonstrated leadership and team management experience. Ability to build and lead overseas clinical teams, drive the professional development of team members, and foster a highly collaborative work environment.