R&D Pre-Clinical Manager

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)