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Telix Pharmaceuticals (EMEA)
Clinical Pharmacology Director
Geneva
November 5, 2024
We are seeking an experienced Clinical Pharmacology Director to join the Clinical Strategy and Innovation team. This person will be responsible for leading the clinical pharmacology strategies for the company's portfolio of radiopharmaceutical assets. The successful candidate will play a pivotal role in ensuring the optimal design and execution of clinical pharmacology studies to support the development of novel diagnostic and therapeutic radiopharmaceuticals. This role will require collaboration with cross-functional teams including clinical development, regulatory, medical affairs, and research & innovation to bring groundbreaking treatments to market.
Key Accountabilities:
- 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.
- Stay up to date with trends and technological advancements in radiopharmaceuticals, pharmacokinetics, and clinical pharmacolog
- Ph D, Pharm D, or MD degree required; Specialization in Clinical Pharmacology, Pharmacokinetics, or related field strongly preferred
- 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).
- Excellent written and verbal communication skills
- Excellent negotiation, communication, and interpersonal skills, with the ability to build and maintain relationships with diverse stakeholders
- Self-motivated, goal-oriented, and able to work independently as well as collaboratively within cross-functional teams
- Highly organized and able to prioritize deliverables across clinical assets/programs
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.
VIEW OUR RECRUITMENT PRIVACY POLICY HERE
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