Director of Clinical Operations

Posted: 27 September 2023

The Client

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.

The Opportunity

  • 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.

The 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.

The Offer

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 or contact Mark Thomas or Marilyn Jones at 1300 0 MEXEC for a confidential discussion about the role


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