Associate Director / Director, Clinical Operations — Asia-Pacific

AusperBio Therapeutics, Inc.; Hong Kong; Hybrid; HKD 1,200,000 - 1,900,000; Full time

Benefits offered by this job

Hybrid working

Competitive base salary

Equity program eligibility

Hong Kong MPF and medical coverage

Generous annual leave

Job summary

AusperBio Therapeutics Inc. is seeking an Associate Director/Director of Clinical Operations based in Hong Kong to lead APAC clinical operations. You will guide planning, execution, and oversight across multiple countries, managing CROs, vendors, and timelines while liaising with global teams.

The role requires senior-level experience in Asia-Pacific trials, strong regulatory knowledge, and English fluency; Mandarin is highly preferred. Expect a fast-paced startup setting with regional travel.

Qualifications

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
• 8+ years of clinical operations experience for the Associate Director level, or 10+ years with regional or people leadership for the Director level.
• Experience managing multi-country APAC trials; start-up/ethics submissions in two or more APAC markets preferred.
• Sponsor-side oversight of CROs and external vendors within a regional/global program.
• Regulatory knowledge across APAC including Hong Kong and China frameworks.

Responsibilities

• Act as the APAC clinical operations lead, delivering regional study timelines, budgets, and resourcing.
• Own CRO/central lab/vendor selection and performance; ensure quality and timely issue resolution.
• Drive site activation and enrollment, building relationships with investigator sites and hospitals.
• Ensure ICH-GCP compliance and local regulatory requirements; manage risks and metrics.
• Collaborate with global partners and China teams; align with US leadership and cross-functional teams.

Skills

Fluency in English

Mandarin proficiency

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

CTMS

eTMF

Study Start-Up

Job description

Location: Hong Kong SAR|Regional Scope: Asia-Pacific (APAC)|Employment Type: Full-time

Title offered at Associate Director or Director level, commensurate with experience.

About Us

AusperBio Therapeutics Inc. is a clinical-stage biotechnology company advancing innovative therapies for patients with serious unmet medical needs. With active Phase 1 and Phase 2 programs conducted globally, we operate in a collaborative, fast-paced startup environment and maintain strategic partnerships with international development teams, including a China-based counterpart organization. Our Hong Kong presence is the regional hub connecting U.S. leadership with clinical, development, and manufacturing partners across Greater China and the wider Asia-Pacific region.

Position Summary

Based in Hong Kong, the Associate Director / Director, Clinical Operations will own clinical operations across the Asia-Pacific region, providing operational leadership for the planning and execution of our APAC clinical trial portfolio and representing the region within global study teams. The role holds regional accountability for study timelines, CRO and vendor performance, country and site delivery, and cross-functional coordination, and serves as the key operational liaison with international partners — including China-based collaborators — bridging U.S., Greater China, and APAC time zones. Scope spans Hong Kong and markets such as New Zealand, Australia, South Korea, Japan, Taiwan, and Singapore, with the footprint evolving as the portfolio grows. The ideal candidate thrives in a hands-on startup setting and has managed multi-country trials across Asia-Pacific.

Key Responsibilities

Regional Leadership — Asia-Pacific

• Act as the clinical operations lead for Asia-Pacific, accountable for regional delivery of assigned studies across countries and sites.
• Develop the regional operational strategy — country selection, feasibility assessment, and enrollment planning across APAC markets.
• Manage regional study budgets, timelines, resourcing, and forecasts, and provide regional inputs into global program plans.
• Maintain regional start-up, including regulatory timelines, import and licensing considerations, country-specific constraints — and bring it into global planning.
• Represent Asia-Pacific in global study teams and governance forums, escalating regional risks, issues, and resourcing needs to company leadership.
• Build and, as the portfolio grows, line-manage the regional clinical operations team.

Study Execution and Vendor Oversight

• Lead operational planning and execution of clinical trials from study start-up through close-out.
• Own CRO, central laboratory, and vendor selection and oversight, ensuring quality, timeline, and budget performance and timely issue resolution.
• Drive site selection, activation, and enrollment performance, building relationships with investigator sites, academic centers, and hospital networks across the region.
• Ensure compliance with ICH-GCP, company SOPs, and applicable requirements, including Hong Kong Department of Health and Pharmacy and Poisons Board clinical trial certificates, local IRB/IEC processes, and the Personal Data (Privacy) Ordinance.
• Identify operational risks, implement mitigation strategies, and report key study metrics and milestones to cross-functional teams and leadership.
• Ensure high-quality clinical trial data and documentation are maintained.
• Support audit and inspection readiness, including global audits and CAPA follow-up.

Collaboration and Working Model

• Serve as the key operational interface with global and China-based partners, supporting harmonized study conduct, timelines, and data quality.
• Partner closely with clinical development, regulatory affairs, quality assurance, biometrics, pharmacovigilance, and CMC teams, and support development and review of protocols, ICFs, study manuals, and CSRs.
• Leverage Hong Kong’s regional position to provide same-time-zone support to Greater China and APAC sites, flexing working hours as needed to collaborate with U.S. colleagues and global partners.

Qualifications

• Bachelor’s degree in life sciences or a related discipline; advanced degree preferred.
• 8+ years of clinical operations experience for the Associate Director level, or 10+ years with regional or people leadership for the Director level; experience with Phase 1 and Phase 2 trials required, with sponsor-side oversight preferred. Strong CRO-side candidates who have led sponsor-facing regional programs will be considered.
• Demonstrated experience managing clinical trials across multiple Asia-Pacific countries; hands-on start-up and ethics or regulatory submission experience in two or more APAC markets are strongly preferred.
• Proven sponsor-side oversight of CROs and external vendors within a regional or global program structure.
• Therapeutic-area experience in infectious disease (hepatitis B preferred) or nucleic-acid therapeutics is an advantage.
• Strong working knowledge of ICH-GCP and APAC regulatory frameworks, including Hong Kong clinical trial certificate submissions and familiarity with NMPA, FDA, TGA, MFDS, PMDA, and HSA requirements.
• Hands-on experience with clinical trial management systems (CTMS), eTMF, and Study Start-Up.
• Experience line-managing, mentoring, or matrix-leading clinical operations staff preferred; required at the Director level.
• Fluency in English required; proficiency in Mandarin strongly preferred for engagement with local sites and China-based partners.
• Existing right to work in Hong Kong, or eligibility to obtain a Hong Kong employment visa.
• Willingness to travel regionally and internationally (approximately 20–30%), and the ability to operate effectively in a fast-paced startup environment with evolving priorities.

What We Offer

• Regional ownership of clinical operations across Asia-Pacific, with the opportunity to build the function and team as the portfolio expands.
• Direct exposure to U.S. leadership and Greater China development partners at a growing clinical-stage biotech.
• Competitive base salary, performance bonus, and eligibility to participate in the Company’s equity program for full-time direct hires.
• Hong Kong statutory benefits including MPF and medical coverage, annual leave above statutory minimum, and flexible hybrid working.

Equal Opportunity

AusperBio Therapeutics Inc. is an equal opportunity employer. We consider all qualified applicants without regard to sex, pregnancy, marital or family status, disability, race, color, religion, nationality, age, or any other status protected under Hong Kong law. Personal data collected during recruitment is used solely for that purpose and handled in accordance with the Personal Data (Privacy) Ordinance.