Deze vacature is niet beschikbaar in je land.

Clinical Pharmacology Director

Telix Pharmaceuticals (EMEA)Luik, Luik, Belgium

3 dagen geleden

Functieomschrijving

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

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 pharmacology.

Education and Experiences :

PhD, PharmD, 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).

Key Capabilities :

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.

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.

VIEW OUR RECRUITMENT PRIVACY POLICY HERE

J-18808-Ljbffr