Location: PYC Therapeutics Perth, Western Australia
Job title: Toxicologist
Direct report: Director Nonclinical R&D
About PYC TherapeuticsPYC Therapeutics (ASX: PYC) is a clinical-stage biotechnology company creating a new generation of RNA therapies to change the lives of patients with genetic diseases. The Company utilises its proprietary drug delivery platform to enhance the potency of precision medicines within the rapidly growing and commercially proven RNA therapeutics class. PYC's drug development programs target monogenic diseases – the indications with the highest likelihood of success in clinical development. The Company was the first to progress a drug candidate for a rare blinding eye disease of childhood into human trials in 2023 and is now progressing multiple 'fast-follower' programs into the clinic.
About The RoleLife-changing science is our focus, we start there and everything else follows.
We are seeking a highly motivated and experienced Toxicologist to join our team at PYC Therapeutics. The Toxicologist will play a crucial role in supporting the development of our preclinical- and clinical-stage drug candidates by conducting and overseeing toxicology studies. This position requires a strong understanding of toxicology principles, regulatory requirements, and the drug development process.
The successful candidate will:
Design, conduct, and oversee toxicology studies, including in vivo and in vitro assays, to assess the safety and toxicity of drug candidates. Interpret and analyse toxicological data, preparing detailed reports and presentations for internal and external stakeholders. Collaborate with scientists and regulatory affairs professionals to ensure compliance with regulatory requirements, such as GLP and ICH guidelines. Engage, contract, manage and coordinate consultants, subject matter experts and contract groups and organizations as needed. Assist in the preparation of regulatory submissions, including INDs (Investigational New Drug applications) and NDAs (New Drug Applications). We are recruiting for a full-time position.
Only candidates with ongoing unrestricted rights to work in Australia will be considered. The Person:You are always looking to learn and find new ideas and are not afraid to try something that might fail. You communicate with clarity, concisely and respectfully and you understand we succeed together. You keep yourself to the highest of standards but know how to be pragmatic in delivering outcomes…our patients can't wait.
You have experience in coordinating studies for inclusion in regulatory submissions. You have expertise in managing internal and external parties, consistently delivering projects on time and on budget. We will highly value your diversity of experience and the perspectives you will bring.
Selection criteria - Essential: PhD in toxicology, pharmacology, or a related field. At least five years' experience in toxicology, preferably in the pharmaceutical industry. Strong understanding of toxicology principles, regulatory requirements (e.g., GLP, ICH), and drug development processes. Experience in designing and conducting in vivo and in vitro toxicology studies. Proficiency in data analysis and interpretation. Excellent communication skills, including interpersonal skills and ability to present data to large audiences. Ability to work both independently and as a part of dynamic, cross-functional team environments. Familiarity with regulatory submissions (INDs, NDAs). Selection Criteria - Desirable: Experience or knowledge of antisense oligonucleotides and the requirement and design of preclinical studies to facilitate their smooth translation to the clinic. Experience in toxicology requirements for regulatory submissions addressing kidney, ocular, and/or CNS indications. Track record of engagement with regulatory bodies such as FDA, TGA, EMA. Applications MUST include: A statement addressing the selection criteria. The applicant's curriculum vitae. The contact details of two current referees. #J-18808-Ljbffr