Leveraging an experienced team of pharmaceutical industry professionals and biotech entrepreneurs to develop a promising, novel small-molecule drug candidate, our client is a UK-based biotech looking to expand their clinical program within Australia. Their goal is to develop their first-in-class approach and apply it to a range of cancers, ultimately advancing the range of therapeutic options available and improving the treatment outcomes of patients with these conditions.
As the local clinical operations expert, you will oversee all aspects of commencing and developing a clinical study program within Australia. Working closely with our client’s leadership team and local stakeholders, you will:
Oversee the development and delivery of a local clinical research program.
Provide input into trial design and translate scientific imperative into operational delivery of trials.
Identify and form partnerships with local CROs for the successful execution and delivery of trials.
Provide guidance on and ensure compliance with Australian regulatory frameworks and policies.
Proactively identify risks pertaining to clinical trial execution, providing actionable plans and mitigation strategies.
In conjunction with global team, review clinical trial data – monitor data quality and ensure appropriate quality measures are in place.
Review protocols, study plans, IP management plans, CSRs and other trial-related documentation.
Advise regarding the development of IND/Clinical Trial Authorisation (CTA) and ethics committee packages and documentation, in alignment with related objectives and regulatory requirements.
BSc/ PhD in a relevant scientific discipline.
At least 5 years of clinical research experience in industry (Pharma, biotech or CRO) preferably in Phase 1-3 oncology/immunotherapy drug development.
A broad understanding of drug development including CMC, Regulatory, Safety and non-clinical activities.
Demonstrated track record of clinical trial delivery across the product lifecycle but strong preference for candidates with early clinical development experience.
Experience of successfully leading trial site and CRO interactions.
Proven capability to innovate and guide trial activities where pathway is not well defined and bespoke solutions are required.
Excellent communication skills both verbally and written; flexibility to adapt to communicating across all stakeholder groups.
Our client is offering a highly competitive salary package for a suitably experience candidate whose career aspirations align with their current requirements. For more information, you can email our team at firstname.lastname@example.org or contact Mark Thomas or Marilyn Jones at 1300 0 MEXEC for a confidential discussion about the role