Clinical Development Associate Medical Director to Medical Director

Location

Guangzhou, Guangdong, China 

Position Summary

The Clinical Development Medical Director (CDMD) is responsible for leading late-stage clinical programs from an end-to-end clinical development perspective. As CDMD, you will have oversight of the clinical development for the assigned program(s) and drive the execution of the clinical development plan. In this role, you will work closely with cross-functional colleagues from clinical pharmacology, regulatory affairs, clinical operations, etc.

Your responsibilities will include:

• Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project(s).
• Serve as medical monitor for clinical trials and ensure high-quality data generation.
• Lead strategy for clinical trials and supporting program-level regulatory documents.
• Drive execution of the program(s) and/or clinical trial(s) in partnership with cross-functional colleagues including clinical operations, clinical pharmacology, and regulatory affairs.
• Support safety/pharmacovigilance colleagues to ensure an accurate and updated safety profile of the molecule(s).
• Support and in some cases lead the development of key documents including, but not limited to, study protocols, clinical study reports, data monitoring committee charters, and final study result manuscripts.

Minimum Requirements:

• MD or equivalent medical degree is required in addition to sophisticated knowledge and clinical training in the medical/scientific area; Clinical practice experience  ≥ 2 years (including residency) preferred.
• The minimum requirement of years of experience in clinical research or drug development in the industry will be commensurate with the level: Associate Medical Director ≥ 3 years, Associate Medical Director ≥ 5 years, and Medical Director ≥ 7 years.
• Fluent in oral and written English.
• Proven track record to interpret, discuss and present efficacy & safety data relating to clinical trial(s).
• Demonstrated ability to establish effective scientific partnerships with key stakeholders in the disease state(s) under development. Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
• Exceptional cross-functional team leadership, with effective interpersonal skills and a teamwork mindset.
• Able to work in a dynamic and fast-paced environment, adaptable to a start-up company’s culture, work with deadlines, and show accountability.
• The final job title and associated responsibilities will be commensurate with the candidate’s level of expertise and company needs.