About The Company Our client is a clinical-stage biotechnology company creating a new generation of RNA therapies to change the lives of patients with genetic diseases. We are seeking a highly motivated Study Lead/Manager/Coordinator with experience in nonclinical research, to join this growing team. This role will play a pivotal role in supporting the development of preclinical and clinical-stage drug candidates by managing and overseeing the nonclinical studies.
About the Role A permanent full-time position, working business hours Monday to Friday, is available for the right candidate, based in Perth. This role is suited to individuals with nonclinical research experience from pharmaceutical, biotech or academic organisations but also those with experience working for a nonclinical CRO and looking to transition to a sponsor-side environment. The following responsibilities can be expected in this role:
- Design, lead and oversee nonclinical studies, including in vivo studies to assess the safety and efficacy of drug candidates
- Interpret and analyse nonclinical data and prepare detailed reports/presentations for internal and external stakeholders
- Liaise with external consultants, subject matter experts and organisations as required
- Collaborate with Scientists and Regulatory Affairs professionals to ensure compliance with relevant regulatory requirements – ie. GLP and ICH guidelines
- Support in the preparation of regulatory submissions, including INDs and NDAs
- Act as the key sponsor rep for CRO-run studies, ensuring everything runs smoothly
- Additional duties and responsibilities as required.
About You To be successful in this role you will have a strong foundation in coordinating nonclinical studies; eager and self-motivated to learn, apply new ideas and not afraid to try something new – even if it fails. You will have a strong desire and ability to work in a fast-paced, study-driven environment. Ideal candidates will have the following:
- BSc or higher in pharmacology or a related discipline
- Previous experience in a nonclinical research setting (pharma/biotech/CRO)
- Experience in designing, coordinating, or overseeing in vivo and/or in vitro toxicology studies and in vivo PK and PD studies
- Familiarity with regulatory submissions (INDs, NDAs) and FDA, TGA and EMA requirements
- Previous experience liaising with CROs to deliver GLP study packages
- Strong organisational skills to ensure studies are executed smoothly and on time
- Excellent verbal and written communication skills.
- Strong analytical and problem-solving abilities.
- Full working rights in Australia.
If you meet the above criteria and are interested in this opportunity, please apply online in the first instance. Alternatively, you can contact Keelie Munroe on keelie@keselect.com or ring 0466 485 542 for a confidential discussion.
KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms. KE Select have established reach throughout ANZ, Asia and the UK and a market presence exceeding ten years. KE Select is quickly becoming the recruiter of choice for many organisations within the Pathology, Life Science, Medical Device and Clinical space.
