Clinical Pharmacology Director

Logo of Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited

πŸ“Remote - United States

Job highlights

Summary

Join Telix Pharmaceuticals as a Clinical Pharmacology Director to lead the clinical pharmacology strategies for the company's portfolio of radiopharmaceutical assets.

Requirements

  • PhD, PharmD, or MD degree required
  • 5+ years of experience in clinical pharmacology required
  • Background in oncology or radiopharmaceuticals preferred
  • Extensive experience in designing and executing clinical pharmacology studies, including the integration of PK/PD, biodistribution, and modeling and simulation
  • Proven experience leading regulatory submissions (e.g., INDs, BLAs, NDAs) and interacting with regulatory agencies (FDA, EMA)

Responsibilities

  • Design and implement clinical pharmacology strategies to support the development of radiopharmaceuticals, including dose selection, pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction studies
  • Provide scientific and clinical leadership in the integration of radiopharmacology and pharmacokinetic modeling to advance therapeutic and diagnostic candidates
  • Collaborate with internal stakeholders to align clinical pharmacology efforts with broader drug development objectives
  • Lead the design of early-phase clinical pharmacology studies
  • Collaborate on the development of clinical study protocols, investigator brochures, and regulatory submissions with cross-functional teams
  • Ensure clinical pharmacology studies comply with regulatory guidelines and are scientifically rigorous
  • Serve as the clinical pharmacology representative in regulatory submissions, including INDs, BLAs, NDAs, and MAAs
  • Engage with regulatory agencies (e.g., FDA, EMA) to address clinical pharmacology questions, and collaborate on the preparation of briefing documents for regulatory interactions
  • Oversee the interpretation of PK/PD data, radiopharmacokinetics, and biodistribution studies
  • Collaborate with biostatisticians and pharmacometricians to conduct modeling and simulation efforts to inform clinical decision-making

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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