Date posted: 27 February 2019
Closing date: not noted
- Liaison Management
- US & Australian Clinical Trials
- New leadership opportunity
Our client is a clinical stage drug development company focused on first in class, oral delivery drugs that address unmet medical needs. A lean organisation with a core team, they are backed by expert consultants and clinicians on a global scale with significant experience in pharmaceutical drug research and development.
Reporting to the CEO, you will be responsible for managing the Phase II trials across multiple sites in the US & Australia. You will bring excellent project management, liaison and strategy input experience. This is a lead role for the company ensuring all deliverables are met in terms of quality, compliance and timing.
- Manage the CRO & develop and maintain strong, collaborative relationships with key stakeholders internally & externally.
- Day-to-day project management of the clinical trials to ensure key milestones, project timelines & deliverables are met in all phases of the trials.
- Financial & budget management of clinical trials in an international environment.
- Preparation of relevant documentation and liaison with ethics committees and regulatory authorities.
- Establish operational processes/process improvement for management of clinical programs.
- Oversee clinical trials supply with relevant CTU’s, & monitoring and auditing of manufacture of product for clinical trial supply.
- Ensure trial is conducted in accordance with ICH/GCP standards & regulatory requirements.
- At least five years of trial coordination experience in a clinical research environment in biotechnology, pharmaceutical, devices or CRO environments.
- Minimum Bachelor’s in a science-based area, e.g. immunology, oncology, drug development
- Strong project management & organisational skills in managing trials and ensuring that all aspects & documentation are attended to with a high level of attention to detail.
- Human health therapeutic experience in a global setting with a solid understanding of drug development.
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
- Strong client facing/client relationship management experience.
- Ability to work hard under pressure and face challenges.
- Budget management/financial project tracking experience.
- Excellent interpersonal and communication skills with the capacity to communicate with individuals across disciplines and at all levels in the organisation.
- Demonstrated ability to work both independently and harmoniously as part of a small agile multidisciplinary team.
- Understanding of US trial requirements essential.
- Experience with the conduct of Phase II & Phase III studies.
Our client offers an exceptionally collegiate 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 to the US is required on a regular basis. As a valued member of this 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 challenge, please call Marilyn Jones on 0437 332 272 for a confidential discussion and/or email your résumé with your cover letter to email@example.com