Director/Sr, Director, CRP
On-site · Shanghai, Shanghai, China
Job Summary
Director/Sr Director, clinical development leadership role responsible for providing medical expertise for planning, execution, management and monitoring of global/regional clinical trials in oncology. Lead medical direction on trial design, collaborate with cross-functional teams to execute programs, interpret trial data and develop scientific conclusions for presentations and manuscripts, contribute to writing and editing study-related documents (protocols, investigator brochure, safety management plan, development plans, clinical summaries), serve as medical monitor and lead representative with regulatory agencies, ensure adherence to SOPs and ethical standards, and participate in ongoing clinical data review and cross-functional collaboration to meet milestones within budgets. Possesses strong leadership in cross-functional teams, ability to communicate effectively, and deep knowledge of regulatory requirements and clinical methodologies.
Required Qualifications
- MD and PhD preferred or internationally recognized equivalent
- 6+ years in an R&D physician role in a pharmaceutical company with clinical experience
- Experience in oncology projects, especially solid tumors, primarily in later-stage projects
- Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines
- Ability to lead cross-functional teams, with integrity, results, and collaboration in a fast-paced environment
- Strong English communication skills
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