Clinical Operations Lead

Redefining radiotheranostics for women's cancers — from molecular design to patient impact.

We are seeking an experienced and hands-on Clinical Operations Lead to join our growing team. Reporting directly to the CEO and CMO, this position will oversee all operational aspects of GAIASO's clinical development program ranging from ethics and regulatory submissions through to site activation, monitoring, study completion and delivery.

This is a unique opportunity to build the clinical function from the ground up in a dynamic, mission-driven biotech environment.

About GAIASO

GAIASO is an emerging Australian biotech pioneering next-generation radiotheranostic Affilin-based imaging and therapeutic agents to transform the diagnosis and treatment of women's cancers. Our mission is to advance precision oncology through first-in-class radiopharmaceuticals that enable earlier detection, targeted therapy, and improved patient outcomes.

With programs advancing towards Phase 0 and Phase 1/2 clinical studies in breast and gynaecological cancers, we are building our internal clinical operations capability to deliver these transformative trials

Responsibilities

• Lead the preparation, submission, and maintenance of ethics applications.
• Manage all aspects of clinical trial start-up, conduct, monitoring, and close-out, ensuring compliance with applicable Australian and international regulations.
• Oversee site selection, initiation, vendor coordination, and contract negotiation.
• Develop, implement, and maintain trial documentation: protocols, investigator brochures, informed consent forms, monitoring plans, TMFs, and SOPs.
• Serve as the primary point of contact for study investigators, sites, and vendors.
• Monitor patient recruitment, data quality, and adherence to timelines and budgets.
• Ensure compliance with safety reporting, data integrity, and regulatory documentation requirements.
• Prepare trial progress reports and presentations for senior management, the Board, and regulatory agencies.
• Contribute to the long-term development of GAIASO's clinical operations framework, SOPs, and quality systems as the company scales.

Qualifications

About You

We're looking for a self-driven professional who thrives in a lean, fast-moving environment. You will be the kind of person who enjoys both strategy and execution being equally comfortable drafting an ethics submission as you are presenting a trial status report to leadership.

Essential Qualifications & Experience

• Bachelor's degree in life sciences, pharmacy, nursing, or related field.
• Minimum 6–8 years' experience in clinical operations or trial management (biotech, pharma, or CRO).
• Proven track record in HREC submissions and early-phase (Phase 0 to 2) oncology trials.
• Strong knowledge of ICH-GCP, TGA, and FDA regulatory frameworks.
• Experience in site monitoring and vendor oversight.
• Excellent communication, organisation, and project management skills.
• Ability to work autonomously and collaboratively in a small, cross-functional team.

Desirable

• Prior experience with radiopharmaceuticals or theranostic agents.
• Understanding of global clinical development pathways (IND/CTA).
• Experience preparing for ethics and regulatory inspections or audits.

What We Offer

• The opportunity to shape a clinical program at the frontier of precision oncology.
• A collaborative, science-driven culture where your impact is visible.
• Competitive salary, plus superannuation and performance bonus.
• Flexible hybrid working environment.
• Professional development and international conference attendance.

How to Apply

Please submit your CV and a short cover letter outlining your experience with the key responsibilities to

Applications will be reviewed on a rolling basis. Only shortlisted candidates will be contacted.