Pioneer early-phase clinical research in APAC! ICON seeks a home-based Senior Project Manager in Australia to lead FIH & Phase I studies across ANZ & globally. Shape our growing Early Development portfolio. Apply now.
Pioneer the Future of Early Development from Australia
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of therapies that save lives and improve health.
We are launching a pioneering expansion of our Early Development team in the APAC region and are seeking an experienced Senior Project Manager to be a foundational leader. This is a unique, home-based opportunity in Australia to shape and drive early-phase clinical studies (Phase I, FIH, ClinPharm) across Australia and New Zealand, with scope to support innovative studies in North America and Europe. If you thrive in a dynamic, autonomous environment and are passionate about the science of first-in-human research, this is your chance to build something significant.
Your Mission: Lead from Concept to Proof-of-Concept
As a Senior Project Manager in Early Development, you will be the strategic and operational captain for complex, fast-paced early-phase trials. You will leverage your deep expertise to navigate the unique challenges of early development, ensuring rigorous execution from study start-up through to delivery, setting the stage for future clinical success.
Key Responsibilities
1. Strategic Leadership of Early-Phase Studies
- Serve as the primary accountable leader for the end-to-end delivery of early development (Phase I, FIH, ClinPharm) clinical studies across ANZ and global regions.
- Develop and execute robust, risk-based project plans, ensuring adherence to aggressive timelines, stringent quality standards, and client expectations.
- Provide strategic oversight of all operational components, including site management, clinical monitoring, and vendor partnerships.
2. Expert Site & Operational Oversight
- Lead and oversee critical site management activities, including site feasibility, selection, start-up, and ongoing performance management for specialized early-phase units.
- Manage and guide clinical monitoring teams, ensuring intense protocol compliance and meticulous data quality from the earliest patient cohorts.
- Apply and share deep expertise in Australian and New Zealand regulatory requirements (TGA, HRECs, etc.) and global early-phase standards.
3. Client Partnership & Business Growth
- Act as a key client-facing leader, building trusted partnerships through proactive communication and flawless delivery.
- Confidently represent ICON in bid defense meetings, presenting compelling operational strategies for early-phase programs.
- Contribute to the growth of the APAC early development portfolio by delivering excellence and identifying process improvements.
4. Team Mentorship & Process Shaping
- Provide mentorship and guidance to project team members, fostering a culture of scientific rigor and operational excellence.
- As a pioneer in this growing team, actively contribute to shaping best practices, processes, and the strategic direction of early development operations in the region.
Who You Are: The Ideal Pioneer
You are a seasoned, agile leader with a genuine passion for the science and unique pace of early clinical development. You are a self-starter who excels in autonomy, embraces challenge, and is motivated by building and delivering in a trailblazing environment.
Your Required Foundation:
- Bachelor’s or Master’s degree in Life Sciences, Medicine, or a related field.
- Proven, strong experience in clinical project management within pharma, biotech, or a global CRO, with a focus on early-phase studies.
- Genuine interest and experience in Phase I, First-in-Human (FIH), and/or Clinical Pharmacology (ClinPharm) studies is highly preferred.
- Hands-on experience with managing clinical monitoring activities and site management oversight.
- Solid understanding of Australian and New Zealand clinical trial regulations and ethical review processes.
- Excellent financial, timeline, and risk management skills.
- Outstanding communication, leadership, and problem-solving abilities.
- Adaptable, proactive, and comfortable working autonomously in a pioneering, home-based role.
What Sets You Apart:
- Direct experience managing FIH or complex ClinPharm studies.
- Proven success in bid defense or client-facing proposal delivery.
- Experience working on global, multi-regional studies.
- Established relationships with early-phase clinical units in ANZ.
Why Pioneer with ICON’s Early Development Team?
1. Shape a Growing Frontier
- Be a foundational member of ICON’s expanding Early Development presence in APAC.
- Gain unparalleled visibility and impact, directly shaping strategy and processes.
- Work on cutting-edge science at the very beginning of the drug development journey.
2. Career Autonomy & Growth
- Enjoy a home-based role with significant autonomy and trust.
- Clear pathway to Director-level and leadership roles within the global Early Development group.
- Lead diverse, global studies from your home base in Australia.
3. Comprehensive Remote-Worker Benefits
- Highly competitive salary and performance-based bonus.
- Fully supported home office setup with IT and technology provisions.
- Generous annual leave entitlements and flexible working arrangements.
- Comprehensive private health insurance and wellbeing programs.
- Competitive superannuation planning.
- Global Employee Assistance Programme and dedicated support.
- Opportunities for international collaboration and travel.
Join Our Inclusive Mission from Anywhere
At ICON, we believe diversity drives innovation. We are committed to creating an inclusive, accessible environment and encourage all qualified candidates across Australia to apply for this pioneering remote opportunity.
Ready to lead from the front of clinical innovation?
Apply now to become ICON’s Senior Project Manager in Early Development for Australia.
