Location: Remote (U.S.-based)
Reports to: Chief Medical Officer
Travel: Moderate
About the Opportunity
Atomic Group, a multinational recruitment and executive search firm, is proud to represent an innovation-driven Asian medical technology company that is redefining care standards through the development of highly differentiated technologies. This pioneering company has made rapid progress in the U.S., achieving several FDA approvals for its clinical studies and is now aggressively scaling its operations.
With a growing number of clinical sites planned across the U.S., the company is at a critical inflection point. They are urgently seeking a Director of Clinical Operations to lead clinical execution and drive strategic initiatives that support fast-paced growth in the U.S. market.
Key Responsibilities
Clinical Trial Execution
- Lead and manage the operational execution of clinical trials (from start-up through close-out) in compliance with timelines, budgets, regulatory requirements, and quality standards.
- Oversee internal trial management staff and manage CROs, vendors, and other external partners to ensure clinical delivery excellence.
- Establish and refine operational frameworks and SOPs to support clinical scalability and trial performance.
Site Engagement & Oversight
- Lead U.S. site strategy including selection, qualification, and activation; maintain strong relationships with investigators and site research teams.
- Develop robust site engagement programs to drive strong site performance and early activation.
Patient Enrollment Strategy
- Design and implement data-driven patient recruitment strategies across studies.
- Identify potential enrollment barriers early and lead cross-functional solutions to keep timelines on track.
- Collaborate with internal teams and external stakeholders to support recruitment campaigns and outreach initiatives.
Team Leadership & Development
- Build and mentor a high-performing U.S.-based clinical operations team.
- Create a collaborative and accountable culture focused on quality, innovation, and execution.
- Provide both strategic direction and hands-on support where needed in this lean, growth-phase environment.
Cross-functional Collaboration
- Work closely with Clinical Development, Regulatory, Medical Affairs, and Commercial teams to ensure alignment between clinical operations and company goals.
- Contribute operational insight to broader strategic planning and product development decisions.
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field; advanced degree preferred.
- 8-12 years of clinical operations experience in medical devices industry including at least 3-5 years in a leadership or strategic role.
- Hands-on experience managing Class III innovative medical device trials in the U.S.
- Proven success in leading site engagement and patient enrollment strategies in early-phase and pivotal trials.
- Strong understanding of FDA regulations, GCP, ISO 14155, and related clinical operations best practices.
- Demonstrated ability to thrive in a fast-paced, resource-conscious startup environment.
- Strategic mindset with a pragmatic, hands-on approach to problem-solving.
- Excellent leadership, communication, and cross-functional coordination skills.
What's on Offer
- An opportunity to lead clinical operations for a company delivering breakthrough innovations in the Medtech space.
- High-impact role with visibility to executive leadership and influence on global clinical strategy.
- Competitive U.S.-market aligned compensation package: High upside in bonus and incentive plan
If you are a clinical operations leader who thrives in dynamic, fast-paced environments and are inspired by the opportunity to bring innovative healthcare technologies to patients, we encourage you to apply.
