Senior Manager, Clinical Research

About the role

MSD is seeking a senior leader to drive early clinical research programs in China. The role will shape study protocols, engage key opinion leaders, and prepare regulatory dossiers to support global drug development and registration.

Key responsibilities

• Design and lead early‑phase clinical studies, including protocol development and medical monitoring.
• Collaborate with biostatisticians, regulatory affairs, and global trial operations to ensure high‑quality, feasible study plans.
• Interface between headquarters project teams and the China development centre, translating clinical and pre‑clinical data into actionable study designs.
• Prepare clinical study reports, regulatory submissions, and manuscript drafts for publication.
• Oversee safety and efficacy data capture, review serious adverse events, and approve monitoring plans and data listings.
• Lead laboratory selection, clinical supply applications, investigator meetings, and address protocol deviations during study execution.
• Engage scientific leaders, medical affairs, and marketing to identify patient‑care gaps and develop targeted clinical plans.

Required profile

• PhD or Master in clinical medicine with postgraduate training in oncology or a related field.
• Deep understanding of China’s regulatory environment and clinical development procedures.
• Significant experience in clinical research or development, including strategy, medical monitoring, and protocol writing.
• Strong leadership, project management, and communication skills in both English and Chinese.
• Ability to prioritize multiple tasks and deliver results in a fast‑paced environment.

Required skills

• Clinical trial planning
• Protocol development
• Medical monitoring
• Regulatory dossier preparation
• ICH GCP compliance
• Data analysis
• Risk management