Phase 1 Site Director
CANDIDATE INFORMATION PACK
Momentum Clinical Research
Executive Summary
- Lead a purpose-built private Phase 1 clinical trials unit positioned for significant growth within the New Zealand market.
- Join a rapidly expanding trans-Tasman clinical research organisation at a pivotal stage of transformation, integration and commercial growth.
- Shape a high-performing, sponsor-preferred site delivering complex and First-in-Human studies across a rapidly growing pipeline.
THE OPPORTUNITY
Momentum Clinical Research is the largest trans-Tasman provider of clinical research services, operating across Australia and New Zealand with significant growth ambitions across the Asia-Pacific region. Recently unified under the Momentum brand, the organisation is entering an exciting phase of operational alignment, scalability and market expansion.
The Takapuna Phase 1 Unit is a strategically important, purpose-built private Phase 1 facility established to support the growing demand for complex early phase and First-in-Human studies within New Zealand. Already demonstrating strong commercial performance and increasing sponsor interest, the site is now entering its next stage of operational maturity and growth.
This newly created Site Director role has been established to strengthen operational leadership, sponsor confidence and commercial performance as the organisation continues to scale its Phase 1 capability and market presence.
THE ROLE
Reporting to the Chief Operating Officer, the Phase 1 Site Director will lead the operational, commercial and clinical performance of the Takapuna Phase 1 Unit. The role combines executive leadership with hands-on oversight across complex Phase 1 trial delivery, sponsor and CRO engagement, workforce capability, quality and governance, and commercial growth.
Leading a multidisciplinary workforce, the successful candidate will drive operational excellence across participant safety, protocol execution, audit readiness, workforce utilisation and sponsor satisfaction, while supporting the continued growth and positioning of the site within the market.
THE CANDIDATE
The successful candidate will bring significant experience within Phase 1 or early phase clinical research environments, including exposure to complex and First-in-Human studies.
You will be a commercially astute and operationally credible leader with strong people leadership capability, the ability to build trusted sponsor relationships and experience leading high-performing teams through growth, transformation and operational change. Candidates may come from nursing, medical, health sciences or broader clinical research leadership backgrounds, however demonstrated Phase 1 operational leadership experience will be essential.
For a confidential discussion, please get in touch with:
David Price
HG National Manager, New Zealand
M. +64 (0)210 2392211
E. dprice@hardygroupintl.com
Momentum Clinical Research
Accelerating medical research with the largest network of fully integrated clinical trial sites across Australasia
At Momentum Clinical Research, we take pride not only in the quality and reliability of the work we deliver, but in how we deliver it. Our team is energised by the impact of clinical research, and that energy, personality, and genuine enjoyment infuse every partnership.
We believe the clinical trial journey can and should be both effective and enjoyable — for our research partners and our participants. It’s a privilege to contribute to the advancement of medicine, and we approach that responsibility with both gratitude and a strong sense of human connection.
Momentum Clinical Research (MCR), strengthened by its merger with Pacific Clinical Research Network (PCRN), is a 20-site network across Australia and New Zealand delivering world-class clinical trials from Phase I through Phase IV, including a dedicated Phase I unit. With expanded operational scale, integrated systems, and a growing team of highly skilled professionals, we are positioned as one of Australasia’s most capable and agile trial delivery platforms.
Our Values
Innovative Thinking - We are progressive, future-focused and innovatively minded.
Medical Excellence - We are science led, data driven and meticulous with detail.
Empathic Care - We listen with empathy, we are warm , approachable and easy to work with.
Thriving People - We are principled, people centered and ethically grounded.
Our Evolution
The largest network in Australasia.
Momentum Clinical Research has recently joined with PCRN to form Australia and New Zealand’s largest, most capable clinical trial network. Each of our founding companies contribute over two decades of expertise to create a foundation of knowledge, collaboration, and innovation in clinical research.
With more than 20 sites across the region, we deliver end-to-end trials from Phase 1 to Phase 4. By combining centralised efficiencies with strong local site leadership, we give sponsors faster, more reliable studies while expanding community access to innovative treatments.
What truly sets us apart, though, is the experience of working with us. We’re transparent, we follow through, and we make the process feel personal, positive, and engaging.
NB 6 PCRN Sites to be added post merger. See more about PCRN here.
Our State of the Art Facilities Provide
- Spacious clinics can accommodate multiple participants at a time
- Comfortable consultation rooms for enhanced participant experience
- Multi-purpose rooms adaptable to study requirements
- Special facilities for prolonged participant visits
- Private fully equipped examination rooms
- Fully secure and equipped laboratory and pharmacy rooms
- On-site laboratory for processing biologic samples
- RealTime CTMS platform to enable remote monitoring
- Secure controlled document storage for commercially sensitive and blinded information
- Space for onsite monitoring visits
- Easy access via public transport
Our Current Studies
- Rheumatology - Knee Osteoarthritis Studies
- Endocrinology & Metabolic Disorders, Cardiology - Obesity & Type 2 Diabetes Studies
- Dermatology - Alopecia Areata Studies
- Covid-19 Study
- Hyperlipidemia Studies
- Sexual Health, Urology Studies
- Respiratory Viruses Vaccine Studies
- Bronchiectasis Studies
- Chronic Cough Study
- COPD Study
- Vitiligo Study
- Chronic Kidney Disease & High Blood Pressure Studies
- Coeliac Disease Study
- Cardiovascular Study
- Migraine Study
- Shingles ZOSTER Vaccine Study
- Acne Studies
- Norovirus Studies
- Hives Studies
- Diabetes Studies
- HPV Studies
- Anxiety Studies
- Eczema (Atopic Dermatitis) Studies
- UTI Studies
- Panic Disorder Study
- RSV (Respiratory Syncytial Virus) Studies
- Asthma Studies
Find our current studies here.
Therapeutic Expertise
- General Medicine
- Respiratory medicine
- Endocrinology
- Cardiology
- Gastroenterology
- Dermatology
- Rheumatology
- Immunology and Allergies
- Men and Women’s Health
- Weight Management
- Diabetes and Metabolic
- Disorders, Coeliac Disease
- IBS
- Chronic Pain
- HIV
- Infectious Disease
- Mental health
- Lifestyle Diseases
- PK Studies
- Vaccine Development
- Healthy Participant Studies
Momentum case studies
At Momentum Clinical Research, success is measured by the impact of our work on global healthcare. Over the past 20 years, our clinical trials have contributed to the study data published in groundbreaking research papers and played a vital role in bringing life-changing medications to the global market.
Explore our research case studies to discover how our innovative approach to clinical trials can help scale your research across Australia and New Zealand. More about our success here.
Our Sponsors
Australasia's largest full phase clinical trial network
Introducing the people and processes that drive our uniquely integrated and relationship focused approach to delivering phase l-lV clinical trials. Our scale and centralised efficiency offer a distinct advantage to our partners, but it’s the experience of working with us that really sets us apart. We’re transparent, we follow through, and we make the process feel personal, positive and engaging.
Why sponsors and CROs worldwide partner with Momentum
- Accelerated Start Up
- Reliable Recruitment
- Streamlined and Integrated Process
- Diverse Expertise and Capabilities
- Highest Quality Data and Compliance
More about our world leading Pharmaceutical and Biotech companies partner here.
Role Specification
The Phase 1 Site Director is accountable for the end-to-end leadership, performance, and growth of the Phase 1 clinical trials unit.
This role extends beyond traditional site leadership, combining operational excellence in early phase delivery (FIH and complex protocols), direct sponsor and CRO engagement, commercial performance and growth accountability, and strong people and change leadership to stabilise and scale performance.
The Site Director is the single point of accountability for quality, delivery, and financial performance, ensuring the unit is recognised as a high-performing, audit-ready, sponsor-preferred partner.
Site Leadership and Culture
- Lead a multidisciplinary Phase 1 team across clinical, operational, and administrative functions
- Set clear expectations, performance standards, and accountability across all roles
- Build a high-performance culture focused on precision, ownership, and continuous improvement
- Lead through change, stabilising legacy practices and embedding consistent operating discipline
- Coach and uplift leadership capability across Site Manager and senior coordinators
Phase 1 Operational Delivery
- Oversee end-to-end delivery of Phase 1 trials, including FIH and complex protocols
- Ensure precision execution across participant safety and clinical oversight, protocol adherence and data integrity, sampling accuracy and timing compliance, and unit flow, scheduling, and capacity utilisation
- Drive performance across recruitment and randomisation, visit execution and protocol compliance, and data quality and query turnaround
- Maintain continuous inspection readiness with strong CAPA discipline and audit response capability
Sponsor and CRO Engagement
- Act as the senior operational lead for sponsors and CROs
- Lead site positioning in feasibility assessments, sponsor presentations and qualification visits, and issue resolution and escalation management
- Build trust and credibility through consistent delivery and transparent communication
- Partner with Business Development to convert pipeline into awarded studies
Commercial Performance and Growth
- Accountable for Phase 1 site P&L performance, including revenue delivery and cost control
- Drive optimisation of conversion rates (screening to randomisation), participant throughput and unit utilisation, and cost per visit and staffing efficiency
- Identify and execute growth opportunities, including new sponsor relationships, expansion of therapeutic capability, and increased study complexity and value
- Contribute to pricing, feasibility, and strategic positioning of Phase 1 capability
Workforce and Capacity Management
- Develop and maintain a fit-for-purpose resourcing model aligned to study complexity and demand
- Ensure appropriate mix of investigators, coordinators, and clinical staff
- Optimise rostering and scheduling to maximise utilisation and minimise bottlenecks
- Lead workforce planning aligned to pipeline and growth trajectory
Quality, Risk and Governance
- Ensure compliance with ICH-GCP, AU/NZ regulatory requirements, and internal SOPs and quality frameworks
- Drive proactive risk identification and mitigation across participant safety, protocol execution, and operations
- Embed robust CAPA processes and eliminate repeat findings
- Lead response to audits, inspections, and sponsor escalations
Change and Transformation
- Lead implementation of standardised operating models and systems
- Drive adoption of new processes, including centralised startup and shared services, and technology platforms such as CTMS, QMS, and recruitment systems
- Stabilise and uplift inconsistent or legacy practices
- Deliver measurable improvement in performance, quality, and efficiency
- 8–10+ years in clinical research operations
- Significant Phase 1 or early phase clinical trial experience is required, including delivery of complex protocols such as FIH, intensive sampling, and unit-based studies
- Proven leadership of high-control, high-throughput clinical environments
- Strong track record managing sponsor relationships and escalations
- Demonstrated accountability for operational and financial performance
- Experience leading change and performance turnaround environments
- Deep understanding of ICH-GCP and regulatory frameworks
- Tertiary qualification in health sciences, nursing, or related discipline
Personal Attributes
- Operationally precise and comfortable in high-control, high-complexity environments
- Commercially aware with a strong understanding of revenue drivers and performance levers
- Credible leader across clinical, operational, and sponsor stakeholders
- Decisive and accountable with clear ownership of outcomes
- Resilient under pressure and able to lead in high-stakes environments
- Drives change, challenges legacy practices, and delivers measurable improvement
Key Performance Indicators
- Recruitment and randomisation performance vs target
- Protocol compliance and data quality
- Audit and inspection outcomes
- Sponsor satisfaction and repeat business
- Revenue delivery and cost management
- Workforce utilisation and capacity efficiency
- CAPA effectiveness and reduction in repeat findings
Performance Expectation
The Phase 1 Site Director is expected to deliver measurable improvement in operational performance, quality, and commercial outcomes within the first 6 months, including uplift in conversion, utilisation, and sponsor confidence.
1. Executive Leadership in Early Phase Clinical Research
Demonstrated senior leadership experience within Phase 1 and early phase clinical research environments, including First-in-Human and complex protocols, with accountability for safe, efficient, and high-quality end-to-end trial delivery across high-control, high-throughput operations.
2. Operational Performance, Workforce Optimisation and Delivery Excellence
Proven ability to lead-scale clinical operations through effective workforce planning, utilisation optimisation, and performance management, consistently delivering strong outcomes across recruitment, protocol compliance, visit execution, data integrity, and sponsor delivery expectations.
3. Commercial and Strategic Management Capability
Strong commercial acumen with demonstrated accountability for financial performance, operational efficiency, and sustainable growth, including P&L oversight, study feasibility and acquisition, pricing contribution, and expansion of operational capability and service delivery.
4. Stakeholder Engagement and Organisational Leadership
Highly developed leadership capability with experience building high-performing multidisciplinary teams and trusted sponsor/CRO partnerships, fostering a culture of accountability, continuous improvement, transparent communication, and collaborative problem solving within complex clinical or healthcare environments.
5. Quality, Governance and Transformation Leadership
Extensive knowledge of ICH-GCP and applicable regulatory frameworks, with proven capability to lead quality governance, audit and inspection readiness, risk management, CAPA implementation, and operational transformation initiatives that strengthen compliance, standardisation, and organisational performance.
Reporting To: Chief Operating Officer
Direct Reports: Site Manager, Clinical Operations (Phase 1), Principal and Sub Investigators.
Internal:
- COO, CMO
- Research Area Managers
- Site Managers and Phase 1 staff
- Quality and Risk
- Business Development and Start-Up
- Finance, People and Capability
External:
- Sponsors and CROs (senior stakeholders)
- Principal Investigators
- Vendors and service providers
Please discuss with HardyGroup Consultant
Service Location: Auckland (Takapuna Phase 1 Unit)
The closing date for applications is Thursday, 25th June 2026
The reference number to include in your application is H26_5519
Note: Please use the online platform to submit your application. It will not be accepted via email.
If you require assistance in submitting your application online, please get in touch with Executive Search Coordinator, Aldie Zuñiga: M: +61 (0)494101082 / E: azuniga@hardygroupintl.com
It Is standard practice for HardyGroup to acknowledge receipt of your application no later than the next business day. We request that if you do not receive the acknowledgement, you contact the search coordinator listed above as soon as possible after the 24-hour business period and arrange to resend your application if necessary.
Your application must include:
- 1.Cover letter to the Principal Consultant introducing yourself and addressing the qualifications, requirements and selection criteria;
- 2.An up-to-date copy of your Curriculum Vitae
Please view HG’s Written Application Procedure prior to preparing your documentation and applying for the role.
For a confidential discussion, please contact:
David Price
HG National Manager, New Zealand
M. +64 (0)210 2392211
E. dprice@hardygroupintl.com
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