Principal Investigator (Medical Doctor) - Phase 1b Asthma Study (Contract)

Who We Are

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.

What You'll Do

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 requirementsLead participant safety oversight, including assessment and adjudication of adverse events and prompt escalation of safety concernsConduct and oversee informed consent, eligibility assessment and study-specific procedures at protocol-defined timepointsMaintain appropriate oversight of delegated activities, ensuring roles and responsibilities are clearly understood across the medical teamReview and sign clinical documents, source documentation and case report forms contemporaneouslyChair or participate in safety review meetings and contribute to safety adjudicationEngage with the ethics committee, sponsor and regulators as requiredBe present on site for dosing events and inpatient monitoring periods

Location and working pattern

We operate from a private hospital in North Sydney, with a satellite site in the Sydney CBD. Inpatient dosing and monitoring take place at the hospital, and follow-up visits can be conducted from the satellite site. On-site presence is required for dosing periods.

What You'll Bring

Medical registration with AHPRAPrevious experience as a Principal Investigator, or extensive Sub-Investigator experience and readiness to step into the PI roleFamiliarity with ICH-GCP guidelines and clinical research best practiceExperience in asthma or respiratory trials is favourable but not essential. Training on FeNO and spirometry will be providedStrong attention to detail and a commitment to high-quality clinical researchExcellent interpersonal and communication skills, with the ability to collaborate effectively with a multidisciplinary teamAvailability for on-site attendance during dosing periods

Why You'll Love Working at Vial Australia

Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a first-hand understanding of the challenges involved. This drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life.

Fostering autonomy. Autonomy is our guiding principle. We believe that when team members are entrusted with responsibility, they unleash their true potential. Our culture empowers people to take ownership and make a real impact