Assistant Director, Clinical Operations

Role OverviewHealth 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 ResponsibilitiesLead 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 & ExperienceBachelor'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.