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 careers@mexec.com or contact Mark Thomas or Marilyn Jones at 1300 0 MEXEC for a confidential discussion about the role
