Director, Clinical Operations
- Competitive
- X United States
Join a rapidly growing biotech company at the forefront of cardiovascular and metabolic disease treatment development. This is a unique chance to make a meaningful impact by leading the global clinical development programs of an innovative organization. You will have the opportunity to shape the future of life sciences, working on cutting-edge therapies that aim to improve patient outcomes worldwide. If you’re passionate about clinical operations and eager to contribute to transformative healthcare solutions, this role offers a dynamic and rewarding environment where your expertise can truly make a difference.
Our client is a clinical-stage biotechnology company focused on pioneering first-in-class and best-in-class therapies for cardiovascular and metabolic conditions. With active multi-regional clinical trials in regions including China, the US, and Australia, they are preparing for a significant IPO and are on an exciting growth trajectory. In this strategic leadership role, you will oversee and build the global clinical operations function, ensuring the smooth execution of complex, multi-regional trials that meet the highest standards of quality, compliance, and efficiency. Your leadership will be crucial in coordinating efforts between global headquarters and international clinical teams, CROs, vendors, and investigators.
Role Summary:
As the Director of Clinical Operations, you will lead the end-to-end management of multi-stage clinical trials across various regions. Your role involves developing clinical strategies aligned with the company’s growth plan, overseeing trial execution, and managing relationships with external vendors and CROs. This position is onsite and requires regular collaboration across borders, acting as a key liaison between US, China, and other regions to ensure operational excellence and regulatory compliance. Your work will directly impact the success of the company’s pipeline and global clinical development milestones.
Key Responsibilities:
- Lead the global clinical operations strategy and ensure alignment with development goals
- Oversee the planning and execution of multi-regional clinical trials, ensuring timely delivery within budget
- Build and maintain relationships with CROs, vendors, and investigators, setting clear performance expectations
- Support regulatory interactions, inspections, and audits to maintain compliance with all relevant standards
- Collaborate closely with cross-functional teams including Medical Affairs, Regulatory, and Biometrics
- Recruit, develop, and lead a high-performing global clinical operations team, fostering a culture of excellence and accountability
- Identify operational risks proactively and implement strategies to mitigate issues related to enrollment, site performance, and vendor management
Experience & Requirements:
- Bachelor’s degree in life sciences, medicine, pharmacy, or related field
- 10+ years of clinical operations experience, including leadership roles in biopharma or CRO environments
- Proven track record managing global, multi-center clinical trials, particularly in US and Australia
- Strong knowledge of cardiovascular (CV) or related therapeutic areas is preferred
- Experience working with Chinese biotech/pharma organizations is highly advantageous
- Deep understanding of global trial regulations, MRCTs, and vendor management
- Excellent cross-cultural communication skills and ability to bridge US and Chinese working styles