Merck & Co., Inc. / Merck Sharp & Dohme LLC is seeking a Senior Clinical Research Physician to provide specialized leadership for early-phase oncology clinical development in China. This role focuses on designing and executing Phase 1 and First-in-Human studies in hematological malignancies and future pipelines, directly supporting global development strategy.

What You'll Do

Lead Phase 1 studies in Chinese participants with hematological malignancies.
Provide strong capability to lead study determination and preliminary efficacy signal finding to support global Phase 3 trial development plans.
Lead future Phase 1 trials or First-in-Human (FIH) studies for upcoming oncology pipelines.
Serve as Clinical Lead in the Early China Product Development Team, responsible for developing the optimal China development plan.
Develop study protocols, engage key opinion leaders, draft study reports, and prepare dossiers for regulatory submission.
Abstract high-level relevant clinical and preclinical data to support study design.
Represent the China development center's clinical development team on headquarters project teams and provide feedback from a China perspective.
Drive study design and collaborate with biostatisticians, regulatory affairs, and other disciplines to construct high-quality clinical study protocols.
Interpret, prepare clinical study reports, regulatory dossiers, regulatory responses, and review product labels.
Prepare and review manuscripts for publication.
Work with the study team to ensure safety/efficacy information is adequately captured and review serious adverse events.
Review and approve monitoring plans, reports, and data listings.
Lead investigator meetings during study initiation and perform medical monitoring during study implementation.
Engage scientific leaders and internal stakeholders (medical affairs, marketing, regulatory affairs) to develop clinical plans.
Introduce new compounds in development to China scientific leaders and seek feedback.
Participate in due diligence evaluations as a medical expert.
Work with medical affairs to identify gaps/opportunities in patient care in China and develop clinical plans to capitalize on them.

What We're Looking For

A PhD or Master's in clinical medicine (at least 5-year medical school graduates) with postgraduate training in oncology or a related major.
Deep understanding of China regulatory environment and clinical development procedures.
Strong leadership, excellent written and oral communication skills, and project management skills.
Strong capability for work prioritization and delivering results with parallel multiple tasks.
Excellent language skills in both English and Chinese (fluent in verbal and written).
Flexibility to work outside the area of primary medical specialization.

Nice to Have

Previous experience in clinical research/clinical development, including strategy development, medical monitoring, and protocol writing.
A candidate who is bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful.

Team & Environment

You will serve as the Clinical Lead in the Early China Product Development Team. The role partners closely with the headquarters project development team, China regulatory affairs, project management, and clinical trial operations team.