Head of Clinical Operations (Australia)

Head of Clinical Operations (Australia)The Opportunity (Full-time, Hybrid — Melbourne or Sydney)Taxa is expanding our clinical operations into Australia. We are looking for a person to manage and operate our clinical trials in that region. You'll be the direct line between Taxa and Australian regulatory and ethics bodies — TGA notifications, HREC submissions, amendments, AE reporting, all of it. You'll also need to understand how the data and designs we produce in Australia feed into US FDA strategy. This is not a coordinator role sitting between an international sponsor and a domestic CRO. You'll actually be running our studies end-to-end in Australia as the sponsor and decentralized approving authority, and accountable for their regulatory and operational integrity.You'll also shape the studies themselves. From endpoint selection to visit schedules to PRO instrument design, you're a hands-on partner in protocol development, not just an executor of someone else's design. You'll own the scientific and regulatory integrity of our Australian program. You'll touch the import and biosafety side too: DAFF/BICON permits, GMP chain-of-custody, and any other logistics that keep product moving legally and safely from the US to Australian patients.This role sits within a global team, headquartered in San Francisco. You'll work daily with colleagues based in San Francisco, São Paulo, and Tokyo. Some weeks you'll be deep in an HREC submission; others you're on a call at 10pm reconciling protocol design with the US science team. If you want to build an Australian clinical operation from the ground up, and be in a position of autonomy and ownership, this role is for you.This role reports to Taxa’s Head of Clinical Science (Global).Required Qualifications✔️ Advanced scientific or medical degree: PhD, MD, PharmD, or equivalent advanced degree in a relevant scientific, clinical, or regulatory discipline.✔️ Comprehensive track record of HREC interaction: direct experience leading HREC submissions and ongoing study oversight across 3 or more studies, including amendments, AE reporting, annual reviews, and CTN and/or CTA pathway selection.✔️ FDA-aligned Australian trial design: familiarity with US FDA regulatory frameworks, including IND, 21 CFR Part 11, and FDA pre-submission interactions, with the ability to design Australian studies and data collection to support eventual US filings and minimize bridging studies.✔️ GCP fluency: recent working knowledge of ICH E6(R3) standards and how they apply in an Australian trial context.✔️ Site and trial operations: direct experience running or overseeing one or more clinical trial sites, not just monitoring a CRO's work. ✔️ Protocol design experience: hands-on authorship of clinical study protocols, including endpoints, inclusion/exclusion criteria, and visit schedules, with experience designing studies that ultimately supported regulatory submissions.✔️ Work across time zones: regular collaboration with San Francisco, São Paulo, and Tokyo. Willingness to work highly flexible working hours for international video calls. ✔️ Travel to San Francisco: willingness to make one or two multi-week trips to San Francisco every year.Highly Desirable Experience✔️ Import and biosafety logistics: experience importing foreign medicinal or biological products into Australia, including DAFF/BICON permitting and related import requirements.✔️ GMP/cGMP chain of custody: experience managing compliant international shipment, cold chain, storage, receipt, and accountability of clinical medicines.✔️ Decentralized trial operations: experience running decentralized studies and coordinating vendors, laboratories, couriers, imaging, sites, and site staff training.✔️ Relevant domain experience: prior experience in dermatology and/or microbiome-based clinical research.Transparent Compensation✔️ Base salary — $200,000 AUD annual salary.✔️ Equity — meaningful equity package.✔️ Working environment — hybrid, based in Melbourne or Sydney.