Head of Global Clinical Operations, VP

The Vice President, Head of Global Clinical Operations will serve as the senior leader responsible for the planning, execution, and delivery of all clinical programs across global. This executive will oversee the strategic and operational implementation of clinical studies from Phase 1 through Phase 3, ensuring the highest standards of quality, compliance, and operational excellence.

The VP, Clinical Operations will lead a high-performing global team, manage CRO partnerships, and implement the global clinical development strategy. This role is critical to ensure that Sironax’s clinical programs in neurodegenerative and age-related diseases are executed efficiently, ethically, and in full alignment with regulatory and corporate objectives.

 Strategic Leadership

• Develop and implement the overall clinical operations strategy for Sironax’s global clinical operations.
• Provide operational leadership for all clinical trials from start-up through closeout, including site selection, vendor management, and patient recruitment strategy.
• Serve as a key member of the global leadership team, contributing to cross-functional decision-making and long-term planning.
• Ensure operational readiness for early- and late-phase studies, including resource allocation, risk management, and budget oversight.
• Drive continuous improvement and innovation in clinical operations processes, systems, and metrics.

Clinical Trial Execution

• Oversee the planning, execution and delivery of all clinical trials globally within scope, budget and timelines.
• Manage CROs, central labs and other vendors to ensure adherence to GCP, SOPs, and contractual obligations.
• Implement operational best practices in patient recruitment, site engagement and data integrity.
• Collaborate with Global Clinical Development, Regulatory Affairs and Data Science to ensure seamless operational execution.
• Review study metrics, operational performance, and quality indicators, escalating risks proactively to senior leadership.

Regulatory & Quality Compliance

• Ensure all studies are conducted in full compliance with ICH-GCP, FDA, NMPA, and regional regulatory standards.
• Oversee clinical documentation, trial master file integrity, and audit readiness.
• Partner closely with the global Quality organization to ensure operational inspection readiness and implementation of CAPA plans when needed.
• Provide operational input into regulatory filings and agency interactions for global clinical programs.

Regional Leadership & Team Development

• Build, develop, and lead a high-performing Clinical Operations team across countries.
• Foster a culture of accountability, transparency, and operational excellence.
• Mentor and coach regional directors, clinical program leads, and study managers.
• Ensure effective knowledge sharing and alignment between regional teams.
• Collaborate with HR to design and implement talent development and retention strategies within the clinical operations function.

• Advanced degree in Life Sciences, Medicine, Pharmacy, or related field.
• Minimum 15 years of experience in clinical operations within the biotech, pharmaceutical or CRO industry, with at least 8 years in senior leadership roles overseeing operations globally.
• Proven experience managing global multi-country clinical trials.
• Deep understanding of regulatory requirements in US, China, EU and APAC.
• Experience in CNS, neurodegenerative or inflammatory diseases preferred.
• Demonstrated track record of delivering programs on time, within budget, and with high quality.
• Strong knowledge of operational systems and tools (CTMS, eTMF, EDC, and risk-based monitoring platforms).
• Excellent organizational, analytical, and problem-solving skills with a focus on operational efficiency.
• Proven ability to lead large, matrixed teams and manage external partnerships across geographies.
• Excellent communication and interpersonal skills, with fluency in English and Mandarin.
• Strategic thinker with strong executional discipline and a results-oriented mindset.