Global Clinical Lead
Telix Pharmaceuticals Limited
August 14, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Global Clinical Lead (SME) — design, lead, and implement the clinical development strategy for Telix Therapeutic assets.
Key Accountabilities
- Design, lead, and implement Clinical Strategy: define and drive clinical development plans aligned with asset strategy and commercial objectives.
- Cross-functional collaboration: work with Global Program Heads, Clinical Operations, Regulatory Affairs, Medical Affairs, and the Therapeutic Business Unit Head to integrate clinical trial objectives into the overall development strategy.
- Clinical study design and execution: oversee study plans from concept through protocol finalization; ensure scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements.
- Clinical documentation leadership: lead creation/review of informed consent forms, imaging charters, study manuals, and regulatory dossiers with medical writers and cross-functional teams.
- Regulatory and scientific contributions: provide clinical input into Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global submissions (e.g., INDs, BLAs, NDAs, MAAs).
- Data integrity and analysis: review/interpret/quality control efficacy, safety, and imaging endpoints to support decision-making.
- Stakeholder communication and external engagement: deliver presentations/reports; collaborate with KOLs and advisory boards to inform strategy.
Education and Experience / Qualifications
- Medical degree (MD/MBBS) required.
- Oncology or Nuclear Medicine experience required.
- 5+ years industry clinical development experience; early-phase trial design/execution strongly preferred.
- Solid global regulatory knowledge; experience preparing/submitting INDs/CTAs and engaging with FDA/EMA preferred.
Key Capabilities
- Strong leadership, project management, communication, collaboration, adaptability, resilience, ethical behavior, and continuous learning.
Key Accountabilities
- Design, lead, and implement Clinical Strategy: define and drive clinical development plans aligned with asset strategy and commercial objectives.
- Cross-functional collaboration: work with Global Program Heads, Clinical Operations, Regulatory Affairs, Medical Affairs, and the Therapeutic Business Unit Head to integrate clinical trial objectives into the overall development strategy.
- Clinical study design and execution: oversee study plans from concept through protocol finalization; ensure scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements.
- Clinical documentation leadership: lead creation/review of informed consent forms, imaging charters, study manuals, and regulatory dossiers with medical writers and cross-functional teams.
- Regulatory and scientific contributions: provide clinical input into Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global submissions (e.g., INDs, BLAs, NDAs, MAAs).
- Data integrity and analysis: review/interpret/quality control efficacy, safety, and imaging endpoints to support decision-making.
- Stakeholder communication and external engagement: deliver presentations/reports; collaborate with KOLs and advisory boards to inform strategy.
Education and Experience / Qualifications
- Medical degree (MD/MBBS) required.
- Oncology or Nuclear Medicine experience required.
- 5+ years industry clinical development experience; early-phase trial design/execution strongly preferred.
- Solid global regulatory knowledge; experience preparing/submitting INDs/CTAs and engaging with FDA/EMA preferred.
Key Capabilities
- Strong leadership, project management, communication, collaboration, adaptability, resilience, ethical behavior, and continuous learning.