Global Clinical Lead

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Telix Therapeutic assets seeks a Global Clinical Lead (SME) to design, lead, and implement the clinical development strategy for Telix assets in the United States. You will oversee study design, regulatory input, and cross-functional alignment with medical affairs and regulatory teams.

The role requires an MD/MBBS, 5+ years in clinical development, and strong regulatory knowledge. Oncology or Nuclear Medicine experience is preferred; strong leadership and global submission experience is a plus.

Qualifications

• MD/MBBS degree required.
• Oncology or Nuclear Medicine experience preferred.
• 5+ years in industry clinical development.

Responsibilities

• Design, lead, and implement Clinical Strategy: define and drive clinical development plans aligned with asset strategy and commercial objectives.
• Cross-functional collaboration with Global Program Heads, Clinical Operations, Regulatory Affairs, Medical Affairs, and THUB Head.
• Clinical study design and execution from concept to protocol finalization with regulatory alignment.
• Clinical documentation leadership for ICFs, imaging charters, study manuals, and regulatory dossiers.
• Provide clinical input into Investigator Brochures, DSURs, PSURs, DSURs, INDs/BLAs/NDAs/MAAs.
• Data integrity and analysis of efficacy, safety, and imaging endpoints to support decisions.
• Stakeholder communication and external engagement with KOLs and advisory boards.

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Clinical trial design

Education

MD/MBBS

Job description

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.