Clinical Lead

As the lead clinical affairs employee, this role is responsible for developing and implementing evidence strategies, including company-sponsored studies, investigator-initiated trials, society-driven registries, and real-world evidence analysis. The objective is to design and execute evidence strategies across surgical specialties and product platforms. This position drives the development and implementation of clinical research and evidence generation strategies to achieve business goals and objectives, while adhering to relevant local guidelines and regulations. The role involves collaborating with internal and external stakeholders to develop evidence generation strategies, review evidence concepts, and implement initiatives.

Essential Job Duties:

• Monitor scientific literature to stay updated on scientific knowledge and market trends, contributing to the development of clinical evidence strategies.
• Identify evidence gaps and market opportunities to design and execute evidence strategies that meet local evidence needs and support reimbursement initiatives.
• Contribute to the development and implementation of clinical and medical strategies aligned with business goals, ensuring timely and budget-compliant execution of evidence generation initiatives.
• Collaborate with the commercial function to understand market trends and support business goals through Clinical Affairs activities.
• Collaborate with internal stakeholders (Regulatory Affairs, Global Access Value Economics, Global Public Affairs, Commercial functions) and external stakeholders (advisory boards, KOLs, medical/surgical societies) to develop evidence generation strategies, review evidence concepts, and develop study/evidence designs.
• Plan and execute site selection, investigator selection, patient recruitment analysis, and support the creation of study-related documents (protocols, case report forms, informed consents, clinical trial agreements).
• Participate in data analysis, interpretation, and synthesis, contributing to the development of clinical study reports and scientific publications.
• Ensure compliance with corporate and regulatory requirements, including authoring, reviewing, and revising Clinical Operations Standard Operating Procedures (SOPs) for the region/country.
• Provide an in-depth understanding of the importance of metrics and milestones.
• Manage budgets and resources effectively and efficiently.
• Routinely solve complex problems to enable significant team progress.
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• Previous experience in developing scientific publication strategies
• Strong knowledge of clinical and outcomes research study design
• Experience in conducting literature searches, reviews, and data appraisal
• Excellent interpersonal skills and ability to collaborate with healthcare professionals
• Experience in protocol development and medical writing
• Knowledge of Good Clinical Practice, 21 CFR Part 11, and local regulations
• Understanding of clinical trials, study design, and basic ICH/GCP knowledge
• Ability to work effectively in cross-functional teams and matrix environments
• Ability to build relationships, influence stakeholders, and drive projects forward
• Quick learner with a self-starter attitude towards different surgical specialties
• Dedicated to meeting aggressive timelines and managing multiple projects
• Entrepreneurial mindset and willingness to take risks
• Fluency in Mandarin and En

Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or Master’s degree in a scientific/bioengineering field with 7+ years of experience in clinical affairs/research project/medical affairs management is preferred