Remote Clinical Pharmacology Director

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