360biolabs is Australia's most comprehensive quality‑accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality‑controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.

Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.

To provide leadership and management of studies within 360biolabs’ Clinical Group ensuring that the group supports PK & PD endpoints for clinical trials and preclinical studies as part of an integrated service adhering to industry best practice and all relevant regulatory guidelines.

Key Responsibility Areas

- The key responsibility areas (KRAs) are the major outputs for which the position is responsible and are not a comprehensive statement of the position activities.

Technical

- Assist in the coordination and conduct of method development, optimisation and validation of PK & PD assays, including immunoassays for use in human and animal studies.
- Assist in the design, management and troubleshooting assays for preclinical studies and clinical trials.

Project Management





- Work as part of the Clinical team to execute start‑up activities associated with the implementation of new clinical studies.
- Proactively manage relationships between internal resources and external entities such as vendors, clients and partner organisations.
- Liaise with colleagues and client representatives to ensure study activities are delivered consistent with Work Order timelines.
- Represent the company and the Clinical Group in interactions with clients from initial technical discussions through study initiation, execution and reporting.
- Fulfill the role of Study Director as required.

Data analysis and Reporting

- Maintain reports and records to levels consistent with relevant standards.
- Perform data analysis and data integrity reviews and provide clear interpretation of data to others.
- Produce and review reports and presentations for internal use and communication to clients and external bodies.

Sign Off & Approval Authority

- Validation and Analytical Plans, Protocols and Reports.
- SOPs and Proformas.
- Purchasing (subject to approval limits).

Leadership

- Provide leadership and drive the work ethic and culture of the Scientific Operations group.
- Management of staff including managing priorities, supervision, training and development.

Quality & Accreditation

- Adhere to ISO/IEC 17025,



the OECD Principles of Good Laboratory practice, 360biolabs’ Quality Management System, SOPs, and other requirements as per NATA Accreditation and regulatory guidelines.
- Maintain awareness of, and ensure compliance with, relevant International Standards and Guidelines including ICH GCP.

Safety

- Ensure the protected and efficient conduct of company activities.

Team Work

- Maintain high levels of communication with colleagues and maintain productive relationships with clients, CROs, collaborators and partners.

Professional Development

- Attend and actively participate in company meetings including project and client management, departmental and laboratory meetings where appropriate.
- Participate in professional activities including attendance at conferences, training courses and seminars in the field of expertise.

Key Selection Criteria

- BSc in a Biological discipline (Essential).
- PhD or equivalent experience plus research or industry leadership (Essential).

Experience / Knowledge / Attributes

- Experience in laboratory techniques, pharmacokinetic and pharmacodynamic assays (Essential).
- Experience in method development and validation of immunology assays including cytokine analyses and ELISA (Desirable).
- Experience in the conduct of clinical studies and the processing and analysis of preclinical and clinical samples (Essential).
- Excellent organisational and report writing skills (Essential).
- Ability to work effectively as part of a team (Essential).
- Excellent analytical, interpersonal, verbal and written communication skills (Essential).
- Experience w

📌 Study Manager (Melbourne)
🏢 360biolabs, a BioAgilytix
📍 Melbourne