Director, Clinical Development
Company Summary: A clinical stage biotech harnessing best-in-class siRNA therapeutics is growing their clinical team as they have 3 clinical stage assets in global development across US, AUS, and China.
Key Responsibilities: 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.
The Opportunity: Join a leader in the nucleic acid therapy space as an experienced individual contributor and take on an opportunity to design & execute clinical development plans on a global scale.
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.
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