See Yourself at Telix

We are seeking a dynamic and experienced Sr. Global Clinical Development Lead in Prostate Cancer as part of our Clinical Strategy and Innovation team. The successful candidate will be responsible for designing and executing clinical trials for novel radiopharmaceutical products in prostate cancer. This position offers a unique opportunity to drive clinical development strategy in an area of high unmet need.

The Sr. Global Clinical Development Lead will ensure the prostate cancer therapeutic programs are founded on sound scientific decision-making and are able to be progressed efficiently and effectively towards commercial realization by generating clinical data to serve the requirements of both internal stakeholders and external stakeholders including, but not limited to regulatory authorities, healthcare professionals, patient groups, guidelines committees, payors, and pharmaceutical and business development collaborators.

The Sr. Global Clinical Development Lead will work closely in a matrix organisation with the respective Global Program Leads, Clinical Operations, Medical Affairs, Regulatory Affairs, Manufacturing, Business Unit Heads and other relevant cross-functional teams to advance Telix Group’s assets towards the clinic. This will be undertaken via a deep working knowledge of the existing and future competitive landscape in prostate cancer.

Key Accountabilities:

• Lead development of clinical development plans for therapeutic assets in prostate cancer
• Collaborate with global program heads, regulatory affairs, medical affairs, and translational medicine teams to ensure alignment of clinical trial objectives with overall asset strategy
• Develop clinical study plans from concept to synopsis to full protocol, ensuring alignment with the Company’s objectives, and the needs of regulatory authorities, healthcare professionals, patient groups, guidelines committees and payors
• Develop – in collaboration with relevant cross-functional teams and medical writers – clinical study documentation including, but not limited to informed consent documents, imaging charters, study manuals and final regulatory dossiers.
• Lead clinical scientific input into documentation including investigator brochures, IMPDs, safety reports (e.g. DSURs, PSURs, and SUSARs), clinical study reports and regulatory documents such as briefing packages, INDs, BLAs, NDAs and MAAs
• Lead the analysis, review, and quality control of clinical data (e.g. study-related, aggregated) including efficacy, safety, and imaging data to ensure accuracy and quality
• Prepare and deliver presentations, proposals, and reports for senior management, partners, and other stakeholders

Education and Experience:

• Medical degree required
• Clinical experience in medical oncology or nuclear medicine is essential
• 7+ years of experience in clinical development
• Strong knowledge of clinical trial design, methodology, and regulatory requirements required
• Successful leadership and project management of clinical development programs required
• Experience with regulatory submissions (e.g., IND, CTA) and interaction with regulatory agencies (e.g., FDA, EMA) is preferred

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• 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, continually seeking out opportunities to expand your knowledge and skill