Director, Clinical Operations

About the role

Health Hope Pharma Limited (HHP) is seeking an experienced Director, Clinical Operations to lead the operational strategy and delivery of HHP-sponsored global and regional clinical trials, including multi-regional clinical trials (MRCTs). The Director will be accountable for clinical trial delivery across HHP's development programs, ensuring that studies meet agreed quality, timeline and budget objectives. This role will oversee CROs, vendors and clinical sites; guide cross-functional execution; and provide senior management with clear visibility into study progress, resource needs and key operational risks. As a senior member of the clinical development team, the Director will lead HHP's Clinical Operations function, including its people, processes, systems and governance. The successful candidate will combine strategic leadership with hands-on execution in an evolving biotechnology environment.

Key responsibilities

• Define and lead the operational strategy for HHP-sponsored global and regional clinical trials, including MRCTs, aligned with clinical development and business priorities.
• Direct end-to-end trial delivery across feasibility, country and site selection, study startup, enrollment, monitoring, database lock readiness and study close-out.
• Oversee clinical study budgets, timelines, resource plans and milestones, ensuring effective prioritization and allocation of resources across programs.
• Establish and lead CRO and vendor selection, governance and performance management, ensuring appropriate sponsor oversight and delivery against quality, timeline and contractual commitments.
• Review study performance, budget forecasts, change orders and operational risks; drive timely decisions, corrective actions and escalation where required.
• Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance and other stakeholders to align operational plans with development objectives.
• Provide strategic and operational input into clinical study protocols, informed consent forms, study plans, monitoring plans, vendor scopes of work and other key study documents.
• Oversee enrollment strategies, site performance, monitoring quality and protocol compliance, addressing risks that could affect participant safety, data quality or study delivery.
• Ensure clinical trials are conducted in accordance with ICH-GCP, applicable regulatory requirements, study protocols and HHP policies and SOPs.
• Lead Clinical Operations' contribution to audit and inspection readiness, regulatory inspections and corrective and preventive action activities, in partnership with relevant functions.

About you

• 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 clinical operations leadership experience, with demonstrated accountability for regional or global trial delivery, team leadership and CRO oversight.
• 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, negotiation and performance management.
• Proven ability to manage clinical trial budgets, timelines, forecasts, resources and operational risks across multiple studies or programs.
• 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 build effective processes and teams and collaborate across functions and geographies.
• Strong leadership, stakeholder management, communication, negotiation and decision-making skills, including the ability to communicate effectively with senior management.

About us

Health Hope Pharma Limited (HHP) is a biotechnology company sponsoring global and regional clinical trials across its development programs.