R&D Pre-Clinical Manager
1 week ago
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
As a R&D Pre-Clinical Manager, you will lead and oversee pre-clinical research activities to support the development of new radiopharmaceutical products. You will collaborate closely with cross-functional teams, including scientists, technicians, and regulatory affairs professionals, to ensure the successful execution of pre-clinical studies. Your expertise in pre-clinical research methodologies, regulatory requirements, and project management will be essential in guiding and driving the research activities.
Key Accountabilities
- Lead and manage the pre-clinical research and development activities, including study design, protocol development, and data interpretation, in alignment with company objectives
- Provide scientific and technical guidance to the team on pre-clinical study design, including in vitro and in vivo experimental design, animal models, dosing, and sample analysis
- Oversee the execution of pre-clinical studies, ensuring compliance with regulatory guidelines, good laboratory practices (GLP), and internal quality standards
- Collaborate with internal teams, such as discovery research, chemistry, manufacturing, and controls (CMC), and regulatory affairs, to ensure the seamless progression of projects from pre-clinical to clinical development
- Establish and maintain relationships with external research partners, academic institutions, and contract research organizations (CROs) to leverage expertise, access specialized capabilities, and outsource pre-clinical studies when necessary
- Analyze and interpret pre-clinical data, generate reports, and present findings to internal stakeholders, project teams, and senior management
- Monitor and stay updated on scientific advancement, regulatory requirements, and industry trends relevant to pre-clinical research and development in radiopharmaceuticals
- Contribute to the preparation of regulatory submissions, including Investigational New Drug (IND) applications, and provide scientific support during interactions with regulatory authorities
Education and Experience
- Minimum PhD or DVM and 5+ years' experience in pre-clinical research and development or PharmD and 10+ years' experience in pre-clinical research and development required
- Experience radiopharmaceuticals or nuclear medicine preferred
- Prior experience in late-stage development required
- In-depth understanding of pre-clinical study design, animal models, biodistribution, pharmacokinetics, and toxicology evaluation
- Experience acting subject matter expert in large molecule pharmacokinetics immunogenicity
- Strong knowledge of regulatory requirements governing pre-clinical research, including GLP and relevant guidelines (e.g., FDA, EMA)
- Proven track record of successfully managing and executing pre-clinical research projects, from study design to data analysis and reporting
- Familiarity with radiopharmaceutical manufacturing processes, quality control, and regulatory compliance
- Excellent leadership and team management skills, with the ability to mentor and guide scientists and technicians
- Strong analytical and problem-solving abilities, with attention to detail and accuracy in data interpretation
- Effective communication skills, both written and verbal, with the ability to present complex scientific information to diverse audiences
- Proficiency in using relevant software and tools for data analysis and presentation (e.g., statistical analysis software, Microsoft Office Suite)
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
VIEW OUR PRIVACY POLICY HERE
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