29 Aug
|
BATTERY BIO AUSTRALIA
|
Sydney
29 Aug
BATTERY BIO AUSTRALIA
Sydney
About the role
We are seeking a Principal Investigator to lead the Phase 1b portion of our asthma study, an investigational bispecific antibody programme in adults with mild-to-moderate asthma. This is a contract role with full accountability for trial conduct at the site. You will hold ultimate responsibility for participant safety, protocol adherence and data integrity, supported by a Medical Monitor, Sub-Investigators, research nursing staff and a dedicated clinical operations team.
Key responsibilities
- Hold overall responsibility for the conduct of the trial at the site in accordance with the protocol, ICH-GCP and applicable regulatory requirements
- Lead participant safety oversight, including assessment and adjudication of adverse events and prompt escalation of safety concerns
- Conduct and oversee informed consent, eligibility assessment and study-specific procedures at protocol-defined timepoints
- Maintain appropriate oversight of delegated activities, ensuring roles and responsibilities are clearly understood across the medical team
- Review and sign clinical documents, source documentation and case report forms contemporaneously
- Chair or participate in safety review meetings and contribute to safety adjudication
- Engage with the ethics committee, sponsor and regulators as required
- Be present on site for dosing events and inpatient monitoring periods
About you
- Medical registration with AHPRA
- Previous experience as a Principal Investigator,
or extensive Sub-Investigator experience and readiness to step into the PI role
- Familiarity with ICH-GCP guidelines and clinical research best practice
- Experience in asthma or respiratory trials is favourable but not essential. Training on FeNO and spirometry will be provided
- Solid attention to detail and a commitment to high-quality clinical research
- Excellent interpersonal and communication skills, with the ability to collaborate effectively with a multidisciplinary team
- Availability for on-site attendance during dosing periods
About us Vial Australia Pty Ltd is the Australian arm of Vial, a cutting-edge clinical research organization dedicated to advancing innovative therapeutics through efficient clinical trials. Vial Australia leverages local expertise and infrastructure to conduct high-quality clinical trials for Vial's extensive drug portfolio. Our mission is to bring transformative medicines to patients by executing world-class clinical research in Australia. We combine Vial's innovative approach to clinical trials with Australia's robust regulatory framework and experienced clinical research community.
Vial Australia Pty
Ltd operates as a key strategic partner in Vial's global clinical development programs, providing access to Australia's diverse patient populations and streamlined regulatory pathways. We are committed to maintaining the highest standards of clinical research while accelerating the development of life-changing therapies.
📌 Principal Investigator (Medical Doctor) - Phase 1b Asthma Study (Contract)
🏢 BATTERY BIO AUSTRALIA
📍 Sydney