Director, Clinical Operations

Health Hope Pharma Ltd.; Hong Kong; Presencial; HKD 1 200 000 - 2 300 000; Tempo integral

Resumo da oferta

Health Hope Pharma Limited seeks an experienced Director, Clinical Operations to lead the operational strategy and delivery of global and regional clinical trials, including MRCTs. The Director will oversee CROs, vendors and sites, guiding cross-functional execution and providing senior management with visibility into study progress and risks.

As a senior member of the clinical development team, you will combine strategic leadership with hands-on execution in a dynamic biotechnology environment,

Qualificações

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing or related; advanced degree preferred.
• 10+ years of clinical operations experience in biotech/pharma/CRO.
• At least 3 years in leadership with regional/global trial delivery.
• Experience leading Phase II/III trials, including global/multi-regional studies.
• Experience in CRO/vendor selection, oversight and negotiation.
• Strong budgets, timelines, resource management across multiple studies.
• Knowledge of ICH-GCP and global regulations (FDA, NMPA).
• Oncology or ophthalmology experience preferred.
• Ability to collaborate across functions and geographies; strong leadership.
• Excellent communication with senior management.

Responsabilidades

• Define and lead operational strategy for global and regional trials, including MRCTs.
• Direct end-to-end trial delivery from feasibility to close-out.
• Oversee budgets, timelines, and resource plans across programs.
• Lead CRO and vendor selection, governance and performance management.
• Review study performance, budgets and risks; drive corrective actions.
• Partner with development, regulatory, data management and other functions.
• Contribute to study documents and protocols with operational input.
• Oversee enrollment strategies and site performance to ensure quality.
• Ensure trials comply with ICH-GCP and regulatory requirements.
• Prepare for audits and inspections with relevant teams.
• Develop scalable Clinical Operations processes and governance.
• Mentor and develop Clinical Operations staff.

Conhecimentos

Leadership

CRO Oversight

Budget Management

ICH-GCP Knowledge

Global/Multiregional Trials

Vendor Management

Formação académica

Bachelor’s degree in Life Sciences or related

Advanced degree preferred

Descrição da oferta de emprego

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

Role Overview

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.

• 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.
• Develop and implement scalable Clinical Operations processes, SOPs, tools and governance frameworks to support HHP’s expanding clinical development portfolio.
• Lead, mentor and develop Clinical Operations team members and project managers, establishing clear responsibilities, performance expectations and development plans.
• Present operational updates, risks and recommendations to senior management and contribute to portfolio planning, due diligence and strategic clinical development initiatives.

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 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.
• Ability to prioritize competing demands and guide teams through complex operational challenges in a fast‑paced biotechnology environment.
• A proactive, hands‑on approach, combining strategic judgment with a strong focus on execution and accountability.