- This pharmaceutical innovator works with pharma companies across Australia and internationally to translate laboratory discoveries to pharma medicines.
- Their headquarters are purpose built and equipped with state-of-the-art technologies for R&D, and they specialise in taking a lead compound or idea to final product ready for clinical trials, helping solve pharmaceutical problems.
- A newly created role to make your own.
- Potential to build a team around you in the medium to long term.
- Company is growing which means growth for their people.
- Heavily invested in R&D, manufacturing and clinical trials.
- This Head of Clinical Operations position is responsible for overseeing and leading all clinical operations activities, ensuring clinical studies are conducted in compliance with Good Clinical Practice (GCP), applicable regulatory requirements, ethical standards, and internal procedures.
- This role involves strategic leadership, operational oversight, business development support, and establishment of scalable clinical systems and processes to support the efficient delivery of clinical programmes.
- This position will drive operational excellence across clinical trial activities, support translational development programmes, and collaborate with cross-functional teams to advance client and internal projects from development through to clinical execution.
- A key responsibility of this role will be the development and expansion of a Clinical Research Organisation (CRO) arm, including establishment of operational frameworks, systems, partnerships, and service offerings to support sustainable growth of the organisation’s clinical trial and sponsor support capabilities.
- Development and implementation of clinical operations strategies.
- Establishment and growth of this organisation’s CRO capabilities and service offerings.
- Compliance with GCP, SOPs, ethics requirements, and regulatory standards.
- Oversight and execution of clinical trial activities across all study phases.
- Management of clinical timelines, budgets, vendors, and resource allocation.
- Development and implementation of operational systems, SOPs, and governance frameworks.
- Project execution and delivery across clinical programmes.
- Collaboration with cross-functional teams (Quality, Regulatory, R&D, Manufacturing, etc.).
- Oversight of clinical vendors, CROs, investigators, and site relationships.
- Continuous improvement and innovation in clinical operations processes.
- Introduction and expansion of new clinical service capabilities within the organisation.
- Lead the establishment and growth of the CRO division and clinical trial services capability.
- Develop scalable systems, SOPs, workflows, and operational frameworks to support clinical delivery and ensure full compliance with GCP, regulatory guidelines, ethics requirements, and safety standards.
- Oversee study start-up activities including feasibility assessments, site selection, ethics submissions, contracts, and regulatory documentation.
- Manage relationships with sponsors, investigators, clinical sites, CROs, laboratories, and external vendors (ie. clinicians, hospitals, TGA).
- Degree in Life Sciences, Pharmacy, Medicine, Nursing, or related discipline.
- Experience establishing CRO or clinical services capabilities is mandatory.
- The ideal candidate will also have extensive experience in clinical operations, strong knowledge of GCP and regulatory requirements, commercial awareness, and the potential or experience to build and lead high-performing teams within a dynamic pharmaceutical environment.
- Along with extensive experience (10+ years) in clinical operations within one or more areas within the pharmaceutical or biotech industries, CRO’s, hospitals, research labs in universities involved in clinical trials. Expertise in clinical trial management, operational planning, and process optimisation.
- Ability to drive innovation, process improvements, and operational efficiency.
Please 'apply now' quoting reference number 3837 or call Scott Della-Pietra on 0416.021.937. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.