Senior Clinical Research Lead

About the role

Roche is hiring a Senior Clinical Research Lead in Beijing. The role gives strategic guidance and oversight for clinical programs in Roche Diagnostics China, supporting the registration of Roche Group products such as clinical software, instrument platforms, assays, reagents, devices, systems and biomarkers. It involves active participation in cross-functional project teams and close collaboration with regulatory and lifecycle teams.

Key responsibilities

• Plan and execute local studies, including clinical evaluation, clinical trials and other studies mainly for non-approved product registration in China and possibly elsewhere.
• Implement and maintain clinical trial policies, processes and procedures, including Design Control requirements.
• Manage trial budgets and timelines, and manage internal and external resources.
• Provide input to budgets and identify cost-reduction opportunities.
• Build and lead a team, align its goals with regional and company objectives, and coach team members.
• Review and approve clinical trial documents and oversee central archiving, study supply, regulatory submissions, vendor selection and CAPA effectiveness.
• Maintain relationships with cross-functional leaders, key opinion leaders, investigators and customers, and liaise with Roche Diagnostics divisions and partners.
• Ensure compliance with regulations, SOPs and protocols, and act as a contact point for BAs and other departments.

Required profile

• Bachelor's degree in medical science, preferably clinical medicine, medical laboratory, biochemistry, pharmacology, bio-engineering or biology.
• Minimum of 10 years of experience in clinical research or clinical development in pharma, medical devices, IVD or CRO.
• Proficiency in English and good command of MS Office.
• Understanding of medical device (including IVD) regulations and GCP.
• Two to three years of people management experience is a plus.
• Approximately 20% local and/or international travel.