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AI Job Summary
<ul>
<li>2–5 years in pharma/biotech/CRO with at least 2 years in clinical operations roles (e.g., CTA/CRA/study associate).</li>
<li>Sound ICH-GCP knowledge and clinical trial regulations in at least one region (EU CTR, FDA, or TGA/CTN).</li>
<li>Hands-on experience with TMF, CTMS or EDC systems.</li>
</ul>
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<h3>Role Type</h3>
Permanent • Full-time • Associate
<h3>Description</h3>
About Atisama Therapeutics
Atisama Therapeutics is a clinical-stage biotechnology company pioneering splice-switching oligonucleotide (SSO) therapies that return gene transcription pathways to their optimal form, restoring the molecular balance from disease towards lasting health. Our lead asset, RB042, is an inhaled SSO targeting the Receptor for Advanced Glycation End-products (RAGE). It converts RAGE from its pro-inflammatory isoform to its protective, anti-inflammatory counterpart, a precision approach to COPD and other chronic inflammatory lung diseases.
RB042 is the first application of a broader platform. Aberrant isoform balance drives chronic inflammatory and fibrotic disease well beyond the airway, and we are building a pipeline of SSO programs spanning lung, liver, kidney, ocular and central nervous system indications, each with the target, route of administration and tissue exposure strategy that the organ requires.
The company was spun out of Monash University and late last year raised AU$29 million in Series A funding, led by IP Group Australia and Hostplus with participation from Monash Ventures. In 2026 Atisama and Monash University were awarded AU$15 million in non-dilutive funding from the Australian Government’s Medical Research Future Fund (MRFF) Frontier Health and Medical Research Initiative to support the Phase 1a/1b clinical trial of RB042 in healthy volunteers and people living with COPD.
Our research organisation is based in Melbourne. Our development and clinical leadership operates internationally across Australia, Canada, Europe and the United States.
Role purpose
This role keeps RB042’s clinical studies and development plan on track. You will support the day-to-day running of our clinical trials alongside CROs and vendors, and maintain the integrated program plan, timelines, budgets and risk logs that the leadership team relies on.
It suits someone early in their career who has worked in clinical operations and wants to grow into program management in a hands-on, small-company setting.
Key responsibilities
Clinical and development operations
<ul>
<li>Support study start-up, conduct and close-out for RB042 clinical trials, working day to day with CROs, sites and specialist vendors.</li>
<li>Track site activation, recruitment, data and monitoring milestones against plan; flag slippage early.</li>
<li>Help prepare and review study documents: protocols, informed consent forms, study plans, pharmacy and device manuals, and vendor scopes of work.</li>
<li>Oversee the sponsor Trial Master File (TMF) and support inspection readiness, in line with ICH-GCP.</li>
<li>Coordinate clinical supply and device logistics (drug product and nebulisers) with CMC and vendors.</li>
<li>Support vendor selection, contracting and invoice reconciliation against study budgets.</li>
<li>Help prepare materials for ethics committees, regulatory submissions and investigator meetings.</li>
</ul>
Project management
<ul>
<li>Maintain the integrated RB042 development plan and timeline across clinical, regulatory, CMC, nonclinical and medical affairs.</li>
<li>Run cross-functional program and study team meetings: agendas, minutes, action and decision logs.</li>
<li>Keep the program risk and issue register current, and track mitigation actions to closure.</li>
<li>Track program and study budgets and accruals with Finance; prepare monthly variance reports.</li>
<li>Prepare program status updates, dashboards and slides for the leadership team, board and investors.</li>
<li>Help build and improve project management tools, templates and SOPs as the company grows.</li>
</ul>
Required qualifications and experience
<ul>
<li>Bachelor’s degree in life sciences, pharmacy, nursing or a related field.</li>
<li>2–5 years’ experience in the pharmaceutical, biotech or CRO industry, with at least 2 years in clinical operations (e.g. CTA, CRA, clinical trial coordinator or study associate).</li>
<li>Working knowledge of the drug development process from first-in-human to Phase 2.</li>
<li>Sound understanding of ICH-GCP, and of clinical trial regulations in at least one major region (EU CTR, FDA or TGA/CTN).</li>
<li>Hands-on experience with TMF, CTMS or EDC systems.</li>
<li>Demonstrated project management skills: building timelines, tracking actions and risks, and running meetings.</li>
<li>Strong Excel and PowerPoint skills; familiarity with a scheduling tool (MS Project, Smartsheet or similar).</li>
<li>Clear, organised written and verbal communication, including with external vendors and sites.</li>
</ul>
Preferred qualifications and attributes
<ul>
<li>Experience in respiratory, inhaled or drug–device combination studies.</li>
<li>Exposure to oligonucleotide or other novel-modality programs.</li>
<li>Experience at a small or start-up biotech, where roles flex as priorities shift.</li>
<li>Experience with multi-country trials (Europe, Australia or the US).</li>
<li>A recognised project management qualification (e.g. CAPM, PRINCE2 Foundation) or training in progress.</li>
<li>Highly organised and detail-minded, while keeping sight of the overall program goals.</li>
<li>Proactive: spots issues early, proposes fixes and follows them through.</li>
<li>Comfortable working across functions and time zones with a small, fast-moving team.</li>
</ul>
What we offer
<ul>
<li>Direct exposure to a clinical-stage program and to senior leadership from day one.</li>
<li>A clear development path from clinical operations into program management, with mentoring from the Director, Program Management.</li>
<li>Remuneration is competitive and dependent on experience, plus superannuation.</li>
</ul>

Associate, Clinical Development Operations and Project Management

Associate, Clinical Development Operations and Project Management

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