VP, Clinical Research

The Vice President, Clinical Research will serve as a senior leader within Clinical Development,  responsible for early-stage, Phase 1 and Phase 1/2 studies at Sironax. Based in Beijing, this position provides scientific, medical, and operational leadership with the design, execution, and analysis of first-in-human and proof-of-concept studies conducted globally.

This executive will play a critical role in translating preclinical discoveries into early clinical candidates, driving data-driven decision-making to inform later-stage development. The VP, Clinical Research will work closely with Global Clinical Development, Regulatory, Pharmacovigilance, and Translational Science teams to ensure scientific excellence, regulatory compliance, and operational efficiency in Sironax’s early development pipeline.

Clinical Research Strategy & Leadership

• Help to define and execute the early clinical development strategy for Sironax’s portfolio, including first-in-human (FIH), single ascending dose (SAD), multiple ascending dose (MAD), and Phase 1/2 proof-of-concept studies.
• Serve as the medical and scientific lead for Phase 1–2 trials, ensuring robust study designs that meet regulatory and scientific standards.
• Partner with Preclinical Development, Translational Medicine and Clinical Pharmacology to ensure smooth transition from preclinical to clinical phases.
• Provide scientific input on biomarker strategy, dose selection, and patient population rationale for early-stage programs.

Clinical Execution & Oversight

• Lead the protocol design, implementation, and management of early-stage trials conducted in China and other global regions.
• Oversee site selection, engage with principal investigators to ensure alignment and engagement, and provide clinical monitoring to ensure study quality and GCP compliance.
• Serve as the senior medical monitor for Phase 1/1b/2 studies, ensuring appropriate safety oversight, data review, and interpretation.
• Support the manage of partnerships with CROs, hospitals/sites, and academic institutions to ensure efficient study execution.
• Collaborate with Data Science to ensure timely and accurate data analysis and reporting.

Regulatory & Compliance

• Ensure that all studies are designed and conducted in accordance with ICH-GCP, NMPA, FDA, and EMA requirements.
• Support regulatory interactions related to early development programs, including pre-IND and IND submissions in China and other jurisdictions.
• Provide expert input into Investigator’s Brochures, clinical study reports, and regulatory documents.
• Maintain close collaboration with internal Quality and Regulatory Affairs teams to ensure inspection readiness and compliance.

Cross-Functional Collaboration

• Partner with global Clinical Development, CMC, and Nonclinical teams to align early-stage objectives with long-term development strategies.
• Work closely with Preclinical Development, Translational Research and Biomarker teams to integrate mechanistic and pharmacodynamic insights into clinical decision-making.
• Support internal governance forums, portfolio reviews, and go/no-go decisions for early-stage assets.
• Collaborate with the global leadership team to ensure integration and harmonization between China-based and global development operations.

Leadership & People Development

• Support the building and mentoring of a high-performing Beijing-based Clinical Research organization to ensure the attainment of corporate goals related to Clinical Development.
• Foster a culture of scientific rigor, transparency, and operational excellence.
• Provide strategic leadership and guidance to clinical study teams, ensuring effective communication and decision-making.
• Develop strong partnerships with key opinion leaders (KOLs), academic institutions, clinical networks and clinical sites in China and the broader Asia-Pacific region.

• MD, MD/PhD, or equivalent clinical degree required; board certification in internal medicine, neurology, pharmacology, or related discipline preferred.
• Minimum 12 years of clinical development experience in the biopharmaceutical industry, including at least 8 years in early clinical development (Phase 1/2).
• Proven leadership experience directing FIH and early proof-of-concept studies, including global and China-based clinical trials.
• Strong understanding of drug development regulations and ethics in both China (NMPA) and global regulatory frameworks (FDA, EMA, ICH-GCP).
• Experience in neurodegenerative disease or inflammation-related therapeutic areas preferred.
• Deep expertise in early-phase study design, dose-escalation methodologies, PK/PD modeling, and safety data interpretation.
• Strong operational and medical oversight skills with a proven record of delivering high-quality studies on time.