Global Clinical Lead (Clinical Scientist)

Role Summary

Global Clinical Lead will be accountable for the end-to-end clinical development of novel imaging agents within the FAP program, ensuring that clinical strategy is grounded in robust scientific rationale and aligned with commercial objectives. This includes the design and execution of clinical studies that generate high-quality data to support regulatory submissions, market access, and adoption by healthcare professionals, patient advocacy groups, payors, and strategic partners.

Responsibilities

• Lead Clinical Strategy Development: Define and drive the clinical development plans for Fibroblast Activation Protein (FAP) imaging assets, ensuring alignment with Telix‚Äôs broader asset strategy and commercial objectives.
• Cross-Functional Collaboration: Partner closely with Global Program Heads, Regulatory Affairs, Medical Affairs, and Translational Medicine to ensure clinical trial objectives are integrated into the overall development strategy and reflect the needs of diverse stakeholders.
• Clinical Study Design and Execution: Oversee the development of clinical study plans from concept through to protocol finalization, ensuring scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements.
• Clinical Documentation Leadership: Lead the creation and review of essential clinical documentation‚Äîincluding informed consent forms, imaging charters, study manuals, and regulatory dossiers‚Äîin collaboration with medical writers and cross-functional teams.
• Regulatory and Scientific Contributions: Provide expert clinical input into key regulatory and scientific documents, including Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global regulatory submissions (e.g., INDs, BLAs, NDAs, MAAs).
• Data Integrity and Analysis: Lead the review, interpretation, and quality control of clinical data, including efficacy, safety, and imaging endpoints, to ensure data integrity and support decision-making across the development lifecycle.
• Stakeholder Communication: Prepare and deliver high-impact presentations, proposals, and reports for senior leadership, external partners, and strategic collaborators to communicate program progress and clinical insights.
• External Engagement and Thought Leadership: Cultivate relationships with Key Opinion Leaders (KOLs), organize advisory boards, and collaborate with subject matter experts, consultants, and vendors to inform clinical strategy and enhance program visibility.

Qualifications

• Medical degree (MD) or doctoral degree (PhD) in a relevant scientific discipline is required.
• Therapeutic Area Expertise: Demonstrated experience in oncology or nuclear medicine is required, with a strong understanding of the clinical and scientific landscape.
• Clinical Development Experience: 5 years of industry experience in clinical development, with a proven track record of leading clinical programs through early-phase development. 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 and submitting regulatory documents (e.g., INDs, CTAs) and engaging with health authorities (e.g., FDA, EMA) is preferred.
• Leadership and Project Management: Demonstrated success in leading cross-functional teams and managing complex clinical development programs from concept through execution.
• Strategic and Scientific Acumen: Strong knowledge of clinical trial design, data interpretation, and the ability to translate scientific insights into strategic development plans.

Skills

• Willingness to travel domestically and internationally, as needed
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development

Education

• Medical degree (MD) or doctoral degree (PhD) in a relevant scientific discipline is required.

Additional Requirements

• Travel requirements as noted above