One30 Therapeutics is a pioneering biotechnology company focused on developing innovative antibody therapeutics. Our advanced platform targets one or more disease genes, addressing critical unmet healthcare needs. With a mission to enhance global well-being, we strive to transform lives through groundbreaking solutions. At one30 Therapeutics, we are dedicated to pushing the boundaries of science to bring innovative treatments to patients worldwide.
Position type
Full time / Part time of at least 2-3 days a week
Overview
We are seeking a Senior Clinical Project Manager to lead and oversee the execution of our Phase 1 first-in-human clinical trial in Australia. This senior-level role offers strategic and hands-on involvement across trial planning, site management, vendor oversight, and regulatory compliance. The role is remote and based in Australia, with regular travel required for site visits and meetings.
The successful candidate will act as the local project lead and clinical operations representative, supporting sponsor-side responsibilities while contributing toward documentation and activities relevant to the Australian R&D tax incentive.
This individual may also be asked to support other clinical trials or programs in our pipeline as they advance into clinical development.
Key Responsibilities
* Lead and manage the day-to-day conduct of the Phase 1 clinical trial to ensure delivery on scope, budget, timelines, and quality standards.
* Coordinate operational activities across internal teams, CROs, and vendors to ensure protocol compliance and milestone achievement.
* Act as the main local contact for clinical site(s) and ensure high-quality trial conduct aligned with GCP and local regulations.
Vendor & CRO Management
* Oversee the performance of the selected CRO and key vendors (e.g., central lab, bioanalytics, courier, pharmacy).
* Manage contracts, timelines, KPIs, and issue resolution across third-party providers.
* Participate in CRO selection and budget negotiations where applicable.
Regulatory & Ethical Compliance
* Ensure the study is executed in compliance with ICH-GCP, Australian regulatory and ethics frameworks (e.g., HREC, TGA CTN), and company SOPs.
* Review and support submissions to ethics and regulatory authorities as needed.
* Maintain proper clinical documentation and support audit readiness.
Data & Quality Oversight
* Oversee Trial Master File (TMF) set-up and ongoing maintenance in collaboration with the CRO.
* Review clinical monitoring reports and key study documentation (e.g., ICFs, IRB approvals, deviation logs).
* Support site data entry compliance and help drive timely database entry and query resolution.
Local Sponsor Representation
* Represent the sponsor at site initiation visits, monitoring visits, and audits, if applicable.
* Collaborate with HQ and Australian stakeholders to ensure alignment across clinical activities and R&D reporting.
R&D Tax Support Activities
* Maintain appropriate documentation and timesheets to support the Australian R&D Tax Incentive.
* Contribute to drafting and maintaining SOPs or templates required for internal operations and compliance.
* Assist in the operational set-up of the Australian entity and compliance processes if required.
Preferred Qualifications
* Minimum of 8 years of clinical research experience, with at least 3 years in project or trial management roles.
* Significant experience in a CRO or biotech sponsor setting, with a strong understanding of early-phase trials.
* Prior experience leading early-phase or Phase 1 studies, preferably including PK/PD and dose-escalation trials.
* Strong knowledge of Australian regulatory and ethics processes, including CTN and HREC requirements.
* Experience managing CROs, vendors, budgets, and clinical documentation.
* Excellent communication, organizational, and risk management skills.
* Experience supporting R&D tax compliance or working within an Australian clinical trial entity (a plus).
* Bachelor's or Master's degree in life sciences, nursing, pharmacy, or related field
Work Environment
* Flexible working arrangements.
* Travel for site visits, vendor meetings, or sponsor representation is required (~20-30%).
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