Director of Clinical Development

EPM Scientific are partnered with a clinical stage biotech, harnessing best-in-class siRNA therapeutics who are growing their clinical team as they have 3 clinical stage assets in global development across US, AUS, and China.

You will support the CMO in global clinical development (including China specific programs) for cardiovascular, obesity, and internal medicine therapeutics. You will have owenrship of protocol design, regulatory submissions (NDA/IND/CTD), and trial execution across US, China, and Australia.

Key Responsibilities:

• Reports directly to CMO (based in California)
• Design/execute global CDPs (including China), draft protocols/IBs, and ensure FDA/EMA/NMPA alignment.
• Oversee trial execution (US/China/Australia), ensuring ICH/GCP compliance, data integrity, and risk mitigation with CROs/sites.
• Collaborate cross functionally (regulatory, CMC, BD) and externally (CROs, investigators) to prioritize resources and harmonize global strategies.
• Drive audit ready compliance, lead clinical training for internal/external teams, and optimize operational processes.

Qualifications

• MD (7+ years clinical training)
• 5+ years clinical development leadership (in biotech OR pharma)
• Cardiovascular/internal medicine expertise preferred; RNA/cell/gene therapy experience a plus.
• Proven success navigating China (NMPA), US (FDA), and Australia regulatory pathways.
• Fluent English (oral/written); proven ability to lead matrixed teams across US-China.

If you're interested, please drop a CV and we'll be in touch if it's a good fit.