⨠AI Insights & Summary
This is a pivotal opportunity for a seasoned Global Clinical Lead to shape the future of radiopharmaceutical therapeutics at Telix Pharmaceuticals, a rapidly advancing company focused on precision medicine for cancer and rare diseases. You'll spearhead the clinical development strategy for the company's therapeutic assets, driving innovation from protocol design to regulatory submission. If you're a medical expert with a passion for oncology or nuclear medicine and a proven track record in clinical development, this role offers the chance to make a profound impact on improving patient lives worldwide.
Global Clinical Lead - Therapeutic Assets
About Telix Pharmaceuticals
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with a global presence, dedicated to delivering on the promise of precision medicine through targeted radiation. Our mission is to create products that improve the quality of life for people living with cancer and rare diseases, supporting the international roll-out of approved agents and advancing a portfolio of late-stage clinical products.
About the Role
The Global Clinical Lead is a critical Subject Matter Expert (SME) role responsible for designing, leading, and implementing the clinical development strategy for Telix's therapeutic assets. This role ensures that therapeutic programs are built on sound scientific decision-making, progressing efficiently towards commercialization by generating high-quality clinical data.
Key Responsibilities
- Design, Lead, and Implement Clinical Strategy: Define and drive clinical development plans for Therapeutic assets, aligning with broader asset strategy and commercial objectives.
- Cross-functional Collaboration: Partner with Global Program Heads, Clinical Operations, Regulatory Affairs, Medical Affairs, and Business Unit Heads to integrate clinical trial objectives into the overall development strategy.
- Clinical Study Design and Execution: Oversee the development of clinical study plans from concept to protocol finalization, ensuring scientific rigor and alignment with regulatory, healthcare provider, patient advocacy, and market access needs.
- Clinical Documentation Leadership: Lead the creation and review of essential clinical documentation, including informed consent forms, imaging charters, study manuals, and regulatory dossiers.
- Regulatory and Scientific Contributions: Provide expert clinical input into key regulatory and scientific documents (e.g., Investigator Brochures, IMPDs, DSURs, PSURs, Clinical Study Reports, global regulatory submissions).
- Data Integrity and Analysis: Lead the review, interpretation, and quality control of clinical data (efficacy, safety, imaging endpoints) to support decision-making.
- Stakeholder Communication: Prepare and deliver high-impact presentations, proposals, and reports for senior leadership, external partners, and collaborators.
- External Engagement and Thought Leadership: Cultivate relationships with Key Opinion Leaders (KOLs), organize advisory boards, and collaborate with subject matter experts.
Qualifications and Experience
- Education: Medical degree (MD/MBBS) required.
- Therapeutic Area Expertise: Demonstrated experience in Oncology or Nuclear Medicine required.
- Clinical Development Experience: 5+ years of industry experience in clinical development, with a proven track record of leading clinical programs. Experience in early-stage clinical trial design and execution is strongly preferred.
- Regulatory Knowledge: Solid understanding of global clinical trial methodology, regulatory frameworks, and submission processes. Experience preparing regulatory documents and engaging with health authorities (FDA, EMA) is preferred.
- Leadership and Project Management: Demonstrated success in leading cross-functional teams and managing complex clinical development programs.
- Strategic and Scientific Acumen: Strong knowledge of clinical trial design, data interpretation, and translating scientific insights into strategic development plans.
Key Capabilities
- Commitment to excellence, results-oriented, creative, and innovative.
- Strong communication and collaboration skills.
- Resilience, adaptability, and an inclusive mindset.
- Ethical behavior and a commitment to continuous learning.
Why Telix?
Join an engaged and supportive global team with a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. 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.