Sr. Global Clinical Lead, Prostate Cancer Imaging

See Yourself at Telix

We are seeking a dynamic and experienced Sr. Global Clinical Lead in Prostate Cancer Imaging 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 imaging. This position offers a unique opportunity to drive clinical development strategy in an area of high unmet need.

The Sr. Global Clinical Lead will ensure the prostate cancer imaging 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 successful candidate will function under the Precision Medicine Business Unit reporting to the Chief Medical Officer for Precision Medicine or Senior Global Clinical Lead for Precision Medicine.

The Sr. Global Clinical 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 Groups 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 imaging 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 Companys 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
• Leadership and oversight of a the precision medicine clinical development team

Education and Experience:

• PhD or Medical degree required
• Clinical experience in medical oncology or nuclear medicine is essential
• 7 years of experience in clinical development required
• 5 years leading high functioning global matrix teams required
• 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 skills

Required Experience:

Exec