Our client is a NASDAQ-listed, clinical-stage, pharmaceutical company developing novel therapeutics to address unmet needs in the care and treatment of ophthalmic diseases. They are a dynamic organisation with a highly experienced core team working in conjunction with consultants on a global scale. Their business strategy and therapeutic targets present a considerable opportunity to advance ocular drug research and development – and ultimately improve the lives of patients.
Your key remit will be to manage a number of Phase I & Phase II trials across multiple sites in Australia. You will bring liaison and strategy input experience combined with excellent project management skills. This is a new leadership role for the company, ensuring all clinical operational deliverables are met in terms of quality, compliance, budget, and timing.
Manage CROs and develop and maintain strong, collaborative relationships with key internal and external stakeholders throughout and exceeding the lifecycle of our clinical trial programs.
Proactively manage key aspects of clinical trial programs to ensure key milestones, project timelines, and deliverables are met in all phases of the trials.
Ensure that financial and budgetary management of clinical trials in an international environment.
Be responsible for the preparation of relevant clinical documentation and act as a liaison with ethics committees and regulatory authorities on an ongoing basis.
Drive the improvement of crucial operational processes used in the management of clinical programs.
Work with internal CMC team and leadership to ensure adequate supply chain logistics of drug products for use in the clinical trials.
Ensure all trials are conducted in accordance with ICH GCP standards and meet the appropriate regulatory requirements.
5+ years’ experience coordinating trials in a biotechnology, pharmaceutical, or CRO environment.
Minimum Bachelor’s degree in a life sciences-based field of study.
Strong project management and organisational skills in managing trials and ensuring that all aspects and documentation are attended to with a high level of attention to detail.
A solid understanding of the drug development pipeline for human health therapies.
Good understanding of FDA and ICH GCP guidelines for clinical studies/trials in Australia & the US.
Excellent interpersonal and communication skills with the capacity to manage client relationships and communicate with individuals across disciplines and at all levels in the organisation.
Experience with the conduct of Phase I & Phase II studies.
Demonstrated ability to work both independently and harmoniously as part of a small, agile, multidisciplinary team.
Our client offers an exceptionally collegiate, flexible, and supportive work environment. They expect and provide excellent professional standards and work ethics with a ‘hands on’ attitude. Successful candidates will attract a competitive salary package. Travel throughout Australia is required on a regular basis. As a valued member of this leadership team, you will have the opportunity to demonstrate your talent and shape this emerging business.
If you are interested in joining our client in this exciting new opportunity, please call Mark Thomas or Marilyn Jones on 1300 0 MEXEC for a confidential discussion and/or email your current CV and a cover letter to firstname.lastname@example.org