Principal Scientist, Biomarker & Assay Development

Telix Pharmaceuticals Limited Logo

Telix Pharmaceuticals Limited

πŸ“Remote - United States

Summary

Join Telix Pharmaceuticals as a Principal Scientist, Biomarker and Assay Development to lead and oversee the development and validation of translational assays for safety and efficacy evaluations across the Diagnostic and Therapeutic pipeline. This role supports nonclinical and clinical assay development for new radiopharmaceutical products. You will collaborate with cross-functional teams, manage research and development activities, and ensure compliance with regulatory guidelines. The position requires a PhD in a relevant scientific discipline and 8+ years of experience in preclinical research and development, preferably in radiopharmaceuticals or nuclear medicine. You will analyze and interpret data, contribute to reports, and present findings to stakeholders. Telix offers competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days, and support for learning and development.

Requirements

  • 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)

Responsibilities

  • 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

Preferred Qualifications

  • 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

Benefits

  • Competitive salaries
  • Annual performance-based bonuses
  • An equity-based incentive program
  • Generous vacation
  • Paid wellness days
  • Support for learning and development

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