ASX Biotech Clinical Stage Drug Development The Company
Our client is an Australian-based, ASX-listed clinical stage drug development company developing novel therapeutics in the field of neurology. This world-first technology shows promise in addressing large unmet medical needs which may be able to save lives and improve patient outcomes for millions worldwide. The Role
Reporting to the CEO, and working closely with an experienced small team, you will play a pivotal role in delivering on the strategic direction and execution of product/drug development initiatives. You will bring agility, and the ability to deal with ambiguity. You are collaborative and can see the bigger picture and end goal in sight, however, manage the immediate imperatives to deliver. In addition, your role will encompass:
Supporting the development, execution, and management of product/ drug development plans. Proactively identifying potential risks and develop risk mitigation strategies to ensure successful IND submissions and progression of drug development programs. Data interpretation to provide a comprehensive understanding of the pharmacology of the drug/s and its implications. Assist with CMC, quality, and regulatory documentation development. Assisting to ensure the manufacture of drug product for clinical trials. Excellent communication and interpersonal skills, with the ability to effectively interact with internal stakeholders and external collaborators including consultants, CROs, CMOs, and regulatory authorities. Strategic thinker with a results-oriented mindset and the ability to thrive in a fast-paced, dynamic environment. The Requirements PhD in Pharmacology, Pharmacy, Biochemistry, or related field. Demonstrated experience in project management at a senior level in a biotech or pharmaceutical company. A minimum of 5+ years of pharmaceutical/biotechnology industry experience, with a focus on small molecule drug development and IND-enabling activities. Excellent understanding and technical knowledge of the drug development pathway and associated requirements. Experienced in IND registration and the regulatory field in the USA, Europe and Australia. Strong project management skills and the ability to independently organise various tasks and activities. Demonstrated ability to manage others (e.g. CMOs) and successfully deliver high-quality outputs. Previous experience in preclinical assessment, PKPD evaluation, toxicology studies, and other necessary activities to support IND submissions is an advantage. Flexibility, with work from home, and some travel intestate required. Location maybe in any state in Australia. The Application:
An exciting opportunity with an experienced and passionate team of experts, you will bring collaboration and communication skills to enable a meaningful impact on the lives of patients. You will be ready to champion new ideas in a very dynamic and innovative environment.
Please email any further questions you may have to Marilyn Jones at . To apply, visit our website at and click Apply Now to submit a copy of your current CV and cover letter. Please note the title offered will reflect the successful candidate's skills and experience.
