Job description
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 the Principal Scientist, Biomarker and Assay Development, you will lead and oversee the development and validation of translational assays to evaluate biomarkers for safety and efficacy, in support of both large and small molecules across the Diagnostic and Therapeutic pipeline. A deep (SME level) understanding of large molecule bioassays is essential.
This role will support nonclinical research and development activities, as well as clinical assay development, to support and advance new radiopharmaceutical products. You will collaborate closely with cross-functional teams, including nonclinical scientists, regulatory affairs professionals, and Clinical Science and Operations to ensure the successful execution of clinical development plans. Your expertise in research methodologies, regulatory requirements, and molecular biology will be essential in guiding and driving the research and development activities to support the entire Telix portfolio.
Key Accountabilities
- Lead and manage research and development activities, including assay design, development, and data interpretation, in alignment with company objectives.
- Provide scientific and technical guidance to development team on nonclinical and clinical study designs to include the biomarkers and assays necessary to optimize outcomes (e.g. in vitro and in vivo experimental design, animal models, dosing, and sample analysis).
- Oversee the execution of nonclinical and clinical assays ensuring compliance with regulatory guidelines, good laboratory practices (GLP), good clinical practices (GCP) 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 through nonclinical and 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 studies when necessary.
- Analyze and interpret nonclinical and clinical data, contributing to reports as appropriate, 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 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
- PhD in a relevant scientific discipline (e.g., pharmaceutical sciences, pharmacology) or equivalent industry experience.
- 8+ years experience in preclinical research and development, preferably in the field of radiopharmaceuticals or nuclear medicine
- In-depth understanding of preclinical study design, animal models, biodistribution, pharmacokinetics, and toxicology evaluation.
- Strong knowledge of regulatory requirements governing preclinical research, including GLP and relevant guidelines. (e.g., FDA, EMA)
- Proven track record of successfully managing and executing preclinical 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)
Key Capabilities:
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
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.
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