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Clinical Pharmacology Director

5+ years
Not Disclosed
10 Dec. 13, 2024
Job Description
Job Type: Full Time Education: PhD/PharmD/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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About Telix Pharmaceuticals
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with a global presence. Headquartered in Australia, with offices in Belgium, Japan, Switzerland, and the United States, we are committed to advancing precision medicine through targeted radiation. Our mission is to improve the quality of life for patients with cancer and rare diseases. Join us as we expand the international rollout of our approved prostate cancer imaging agent and develop late-stage clinical products to address significant unmet medical needs.


Role Overview: Clinical Pharmacology Director

We are seeking an experienced Clinical Pharmacology Director to join our Clinical Strategy and Innovation team. This pivotal role involves leading the clinical pharmacology strategies across Telix’s radiopharmaceutical portfolio, ensuring the design and execution of innovative studies that support the development of both diagnostic and therapeutic radiopharmaceuticals. You will work collaboratively with internal stakeholders, including clinical development, regulatory, medical affairs, and research teams, to bring groundbreaking treatments to patients.


Key Responsibilities

  • Strategic Leadership:

    • Develop and implement clinical pharmacology strategies, including dose selection, PK/PD studies, and drug-drug interaction assessments.
    • Provide leadership in radiopharmacology and pharmacokinetic modeling to advance drug candidates.
  • Study Design & Execution:

    • Lead the design and execution of early-phase clinical pharmacology studies.
    • Oversee interpretation of PK/PD data, radiopharmacokinetics, and biodistribution studies.
    • Collaborate with biostatisticians and pharmacometricians on modeling and simulation to guide clinical decision-making.
  • Regulatory Engagement:

    • Serve as the clinical pharmacology lead for regulatory submissions (INDs, BLAs, NDAs, MAAs).
    • Engage with regulatory agencies (e.g., FDA, EMA) to address inquiries and prepare briefing documents.
  • Cross-Functional Collaboration:

    • Align clinical pharmacology efforts with broader drug development objectives.
    • Partner with teams to develop study protocols, investigator brochures, and regulatory documentation.
  • Innovation & Expertise:

    • Stay abreast of trends in radiopharmaceuticals, clinical pharmacology, and technological advancements.
    • Ensure compliance with regulatory guidelines while maintaining scientific rigor.

Education & Experience Requirements

  • Qualifications:

    • PhD, PharmD, or MD required, with specialization in Clinical Pharmacology, Pharmacokinetics, or a related field preferred.
  • Experience:

    • 5+ years in clinical pharmacology, with a background in oncology or radiopharmaceuticals preferred.
    • Expertise in PK/PD integration, biodistribution, and modeling/simulation for clinical studies.
    • Proven track record in regulatory submissions and direct engagement with regulatory agencies (FDA, EMA).

Key Skills & Competencies

  • Communication: Strong written and verbal communication skills with the ability to engage diverse stakeholders effectively.
  • Collaboration: Self-motivated, goal-oriented, and adept at working both independently and within cross-functional teams.
  • Organization: Highly organized with the ability to manage priorities across multiple clinical programs.
  • Innovation: Creative problem-solver with a commitment to excellence in precision medicine development.

Why Join Telix?

At Telix, you’ll join a global, interdisciplinary team driven by a shared purpose: helping people with cancer and rare diseases live longer, better-quality lives.

  • Global Impact: Work on cutting-edge projects in precision medicine across a worldwide network.
  • Inclusive Culture: Be part of a supportive and diverse team where your contributions are valued.
  • Competitive Benefits: Enjoy competitive salaries, performance-based bonuses, equity incentives, generous vacation, wellness days, and learning and development support.

Flexible Work Options: Hybrid and remote opportunities tailored to role requirements.


Telix Pharmaceuticals is an equal opportunity employer. We evaluate candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.

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