Assistant Director, Clinical Operations

Role Overview

Health Hope Pharma Limited (HHP) is seeking an experienced Assistant Director, Clinical Operations to provide operational leadership for HHP-sponsored global and regional clinical trials, including multi-regional clinical trials (MRCTs).

This position will play a key role in the planning and execution of clinical development programs, with responsibility for study strategy, startup, execution and close-out. The successful candidate will provide oversight of CROs, vendors and clinical sites; manage study timelines, budgets and operational risks; and work closely with cross-functional teams to ensure high-quality and timely trial delivery.

The role will also contribute to strengthening HHP's Clinical Operations infrastructure, processes and capabilities as the company's clinical development portfolio continues to advance.

Key Responsibilities

• Lead the operational strategy, planning and execution of HHP-sponsored global and regional clinical trials, including MRCTs.
• Provide end-to-end operational leadership across study feasibility, country and site selection, study startup, enrollment, monitoring, database lock readiness and study close-out.
• Develop and manage clinical study timelines, budgets, resource plans, operational milestones and risk mitigation strategies.
• Provide effective oversight of CROs, vendors, clinical sites and study teams to ensure quality, timelines and contractual deliverables are achieved.
• Lead CRO and vendor governance meetings and monitor KPIs, study performance, budgets, forecasts, change orders and key operational risks.
• Partner closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance and other cross-functional stakeholders to ensure coordinated study execution.
• Review and provide operational input into clinical study protocols, informed consent forms, study plans, monitoring plans, vendor scopes of work and other key study documents.
• Monitor enrollment, site performance, monitoring quality, protocol compliance and emerging operational risks, and implement corrective actions where required.
• Ensure clinical trials are conducted in compliance with ICH-GCP, applicable regulatory requirements, study protocols and HHP policies and SOPs.
• Support clinical trial audit and inspection readiness and participate in regulatory inspections, audits and CAPA activities as required.
• Build, refine and implement Clinical Operations processes, SOPs, tools and governance frameworks to support efficient and scalable clinical development.
• Mentor and develop Clinical Operations team members and project managers, promoting accountability, collaboration and high-quality execution.
• Support portfolio planning, due diligence and other strategic clinical development initiatives as required.

Qualifications & Experience

• Bachelor's degree in Life Sciences, Pharmacy, Nursing or a related discipline; an advanced degree is preferred.
• At least 10 years of clinical operations experience within the biotechnology, pharmaceutical and/or CRO industry.
• At least 3 years of experience in a clinical operations leadership role, with responsibility for regional or global clinical trials.
• Demonstrated experience leading Phase II and/or Phase III clinical trials, preferably including global or multi-regional studies from study startup through database lock and close-out.
• Strong experience in CRO and vendor selection, oversight, governance and performance management.
• Solid experience managing clinical trial budgets, timelines, forecasts, resources and operational risks.
• Strong understanding of ICH-GCP and applicable global clinical trial regulations and requirements, including those of the FDA and NMPA.
• Experience in oncology or ophthalmology clinical development is strongly preferred.
• Demonstrated ability to work effectively with cross-functional and geographically dispersed teams.
• Strong leadership, stakeholder management, communication, negotiation and problem-solving skills.
• Highly organized and able to manage multiple priorities and complex clinical programs in a fast-paced, evolving biotech environment.
• Proactive, hands-on and solutions-oriented, with the ability to operate effectively in both strategic and execution-focused capacities.