NeuShen Therapeutics is an innovative biotech company focusing on neuroscience drug development, especially for innovative drug discovery powered by next generation gene therapy, artificial intelligence etc.

(Senior) Director, Clinical Development is expected to be an inspiring and professional leader to drive the clinical development of Neushen portfolio with high standard and quality. Job title and compensation will be decided based on the qualification and experiences of the candidates.

Strategic Leadership and Program Oversight:

• Lead the development and implementation of clinical strategies in neuropsychiatry, focusing on diseases such as Alzheimer's, Parkinson's, schizophrenia, and major depressive disorder, with an emphasis on neurodegeneration and neuropsychiatric disorders.
• Drive cross-functional alignment on program priorities, development plans, and regulatory strategies in the neuropsychiatric field.

Clinical Trial Design and Execution:

• Oversee clinical trials from early-stage to post-approval, ensuring robust protocol design, regulatory compliance, and data integrity.
• Manage end-to-end clinical operations, from protocol design to KOL engagement and regulatory submissions, with expertise in global CNS compounds development in a global setting.

Regulatory and Compliance Leadership:

• Lead the preparation of regulatory packages, including CTA and NDA submissions, with experience in Chinese regulatory requirements and post-approval commitments.
• Engage with health authorities and regulatory agencies to facilitate approvals, based on prior experience in managing successful submissions for CNS products in China.

Stakeholder Engagement and KOL Interaction:

• Cultivate relationships with key opinion leaders (KOLs) in neuropsychiatry, leveraging extensive experience from past roles to promote clinical programs and enhance trial success.
• Partner with internal teams, including commercial, research, and medical affairs, to align trial outcomes with strategic business goals.

Medical Review and Reporting:

• Lead data analysis and interpretation, working closely with biostatistics and data management teams to ensure clarity and accuracy in clinical reporting.
• Direct clinical study report preparation, leveraging experience in high-stakes CNS and neuropsychiatry study documentation.

Team Development and Leadership:

• Mentor and develop a high-performing team of clinical scientists, medical monitors, and trial managers, fostering a collaborative culture focused on clinical excellence and compliance.
• Provide direction and strategic insight, drawing on significant experience managing teams in CNS and pain management clinical programs.

Requirements:

Education: MD, PhD, or equivalent with a focus on psychiatry or neuropsychiatry.
Experience: 10+ years of clinical development experience with 5+ years in leadership roles specific to neuropsychiatry or CNS.
Skills: Proven expertise in neurodegenerative and psychiatric disorder management, regulatory processes, KOL engagement, and team leadership.