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Global Clinical Lead (Clinical Scientist)

5+ years
Not Disclosed
10 Oct. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Global Clinical Lead (Clinical Scientist)

Location: USA – Remote
Updated: Thursday, 23 October 2025
Company: Telix Pharmaceuticals


About Telix Pharmaceuticals

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, improving the quality of life for people living with cancer and rare diseases.

You will support the global roll-out of Telix’s approved prostate cancer imaging agent and help advance our late-stage clinical product portfolio that addresses significant unmet needs in oncology and rare diseases.


Position Overview

The Global Clinical Lead (Clinical Scientist) will be responsible for the end-to-end clinical development of novel Fibroblast Activation Protein (FAP) imaging agents.

This role involves leading clinical strategy design, execution, and oversight of studies that generate high-quality data for regulatory submissions, market access, and healthcare adoption.

The ideal candidate is a strategic thinker with strong clinical and scientific expertise, capable of collaborating across Clinical Operations, Medical Affairs, Regulatory Affairs, Manufacturing, and Commercial functions.


Key Responsibilities

1. Clinical Strategy Development

  • Lead the design and implementation of clinical development plans for FAP imaging assets.

  • Align clinical strategy with scientific rationale, regulatory pathways, and commercial goals.

2. Cross-Functional Collaboration

  • Partner with Global Program Leads, Regulatory Affairs, Medical Affairs, and Translational Medicine teams.

  • Integrate clinical trial objectives into broader program strategies.

3. Clinical Study Design & Execution

  • Oversee study concept, protocol development, and execution of early-phase trials.

  • Ensure scientific rigor and compliance with regulatory, patient advocacy, and market access requirements.

4. Clinical Documentation Leadership

  • Lead the preparation and review of key documents:
    Informed Consent Forms (ICFs), Imaging Charters, Study Manuals, and Regulatory Dossiers.

  • Collaborate with medical writers and internal teams for high-quality submissions.

5. Regulatory & Scientific Contributions

  • Provide clinical input for:
    Investigator’s Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and regulatory submissions (INDs, BLAs, NDAs, MAAs).

6. Data Review & Interpretation

  • Ensure data integrity, accuracy, and relevance across safety, efficacy, and imaging endpoints.

  • Support decision-making for ongoing development and regulatory milestones.

7. Stakeholder Communication

  • Develop and deliver presentations and reports for senior leadership, collaborators, and external stakeholders.

  • Communicate clinical insights and program progress effectively.

8. External Engagement & Thought Leadership

  • Build and maintain strong relationships with Key Opinion Leaders (KOLs) and advisory boards.

  • Collaborate with experts, consultants, and vendors to strengthen clinical strategies.


Education & Qualifications

  • MD or PhD in a relevant scientific or medical discipline required.

  • Therapeutic Area Expertise: Proven background in oncology or nuclear medicine.

  • Clinical Development Experience:

    • Minimum 5 years in clinical development within the biopharma industry.

    • Proven experience leading early-phase clinical trials and strategic planning.

  • Regulatory Knowledge:

    • Deep understanding of global clinical trial methodology, regulatory frameworks, and submission processes.

    • Experience with INDs, CTAs, and engagement with FDA/EMA preferred.

  • Leadership & Project Management:

    • Demonstrated success leading cross-functional teams through complex development programs.

  • Scientific & Strategic Acumen:

    • Strong capability in trial design, data analysis, and translating scientific insights into business-aligned plans.


Key Competencies

  • Willingness to Travel – domestic and international, as required.

  • Inclusive Mindset – foster diversity and create a collaborative environment.

  • Innovation & Creativity – think beyond conventional methods to solve challenges.

  • Commitment to Excellence – maintain high standards in clinical and operational execution.

  • Results-Oriented – focus on achieving measurable outcomes.

  • Integrity & Ethics – act transparently and responsibly.

  • Adaptability – thrive in a fast-paced, evolving environment.

  • Strong Communication – articulate complex scientific ideas clearly to all stakeholders.

  • Collaboration & Teamwork – work effectively within global, cross-functional teams.

  • Resilience – handle challenges with persistence and positivity.

  • Continuous Learning – remain engaged in professional growth and industry trends.


Why Join Telix

At Telix Pharmaceuticals, we:

  • Believe everyone counts and strive for excellence and integrity.

  • Offer a supportive, global, interdisciplinary team focused on advancing precision medicine.

Employee Benefits Include:

  • Competitive salary and annual performance-based bonuses

  • Equity-based incentive program

  • Generous vacation and paid wellness days

  • Support for learning and professional development

  • Hybrid and remote working opportunities


Equal Opportunity Employer

Telix Pharmaceuticals is an equal opportunity employer.
We evaluate all qualified applicants 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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For global opportunities, visit the Telix Pharmaceuticals LinkedIn page.