Position OverviewA growth-stage biotechnology company focused on innovative therapeutic development is seeking a highly motivated and detail-oriented Clinical Operations leader who thrives in lean, fast-moving environments and is energized by the opportunity to help build infrastructure, teams (direct and/or external relationships), and operational strategy around novel science.
The successful candidate will lead clinical operations for an autoimmune and immunology-focused development portfolio, with a particular emphasis on early-phase and operationally complex studies. Working closely with Clinical Development and broader cross-functional teams, this individual will drive operational strategy, study execution, and CRO/vendor oversight as programs launch across APAC and subsequently expand into the United States and Europe.
This role requires a leader who operates both strategically and tactically-developing scalable operational frameworks while remaining close enough to execution to resolve issues in real time.
The individual will serve as a key operational leader and cross-functional connector, partnering closely with Clinical Development, Clinical Operations, Translational Science, Medical Affairs, Regulatory Affairs, Biometrics, and Quality to ensure aligned and efficient global trial execution.
This opportunity is best suited for a sponsor-side clinical operations leader who takes strong ownership of study strategy, execution, and CRO accountability while fostering collaborative, high-performing partnerships with external vendors and service providers.
Key Responsibilities- Drive clinical operations strategy and execution for an autoimmune/immunology-focused clinical portfolio, beginning within APAC and expanding into the United States and Europe
- Provide operational leadership across all stages of study execution, including feasibility, site selection, study start-up, enrollment strategy, monitoring oversight, vendor management, data quality, and study closeout
- Build and maintain strategic relationships with investigators, institutions, early-phase units, and clinical trial networks across APAC, and establish equivalent partnerships as programs expand globally
- Drive operational excellence and accountability across CROs, vendors, and study partners through proactive governance frameworks, performance metrics, and escalation processes
- Oversee study timelines, budgets, enrollment forecasting, resource planning, and operational risk management to support delivery against program milestones
- Partner cross-functionally with Clinical Development, Translational Science, Medical Affairs, Regulatory Affairs, Biometrics, and Quality to align scientific and operational priorities
- Provide strategic oversight of site engagement and enrollment initiatives, particularly in immunology, autoimmune disease, and advanced therapeutic clinical settings
- Ensure inspection readiness and compliance with ICH-GCP, regional and global regulatory requirements, and applicable clinical trial standards across multiple jurisdictions
- Support development and scaling of internal clinical operations infrastructure, SOPs, processes, and operational best practices appropriate for a growing biotechnology organization
- Directly manage, mentor, and develop clinical operations personnel while supporting growth and expansion of the broader clinical operations function across regions
- Foster a collaborative, accountable, and execution-focused team culture
- Contribute to strategic planning for future clinical programs, including operational scalability across additional indications and geographies
Required Qualifications- Bachelor's degree in life sciences, health sciences, or a related discipline; advanced degree preferred
- 10+ years of progressive clinical operations experience within sponsor biotechnology and/or pharmaceutical organizations
- Demonstrated experience within sponsor organizations where ownership of study strategy, vendor oversight, timelines, budgets, and overall trial execution accountability were core responsibilities
- Significant experience leading global and/or multi-regional clinical trials, including early-phase (Phase I/II) studies, with demonstrated success operating across multiple regulatory jurisdictions
- Strong operational leadership experience in immunology, autoimmune disease, cell therapy, gene therapy, or other advanced therapeutic modalities
- Demonstrated sponsor-side experience overseeing CROs and external vendors, including governance, performance management, escalation management, and operational accountability
- Strong understanding of APAC clinical trial regulations and operational frameworks, with working knowledge of-or demonstrated ability to support-US and European clinical trial requirements and global regulatory standards
- Proven ability to build strategic relationships with investigators, institutions, and site networks across global regions
- Experience operating successfully within lean or emerging biotech environments where flexibility, autonomy, and hands-on leadership are essential
- Excellent leadership, communication, and stakeholder management skills with the ability to influence across organizational levels
- Ability to travel domestically and internationally as required
Preferred Qualifications- Prior experience supporting cell therapy, CAR-T, gene therapy, mRNA, or other advanced therapy medicinal product (ATMP) studies
- Experience supporting autoimmune disease or immunology clinical programs
- Established relationships with investigative sites, clinical networks, and key opinion leaders within APAC and/or globally
- Experience building or scaling clinical operations infrastructure within an emerging biotechnology company
- Familiarity with translational-heavy or biomarker-driven clinical trial designs
- Experience supporting global inspections or regulatory authority interactions
Benefits May Include- Equity participation and long-term incentive opportunities
- Comprehensive medical, dental, and vision coverage for employees and eligible dependents
- Retirement savings program with company contribution or matching opportunities
- Generous paid time off, company holidays, and sick leave
- Paid parental leave and family support benefits
- Flexible or hybrid work arrangements to support work-life balance
- Transportation and commuter assistance programs, where applicable
