Global Product Development Lead - PSMA (Late-Stage)

Location: USA- Remote

Department: Development - Precision Medicine

See Yourself at Telix

The Global Product Development Lead - Px will be responsible for the successful development of diagnostic-related products (up to and including Phase 3 clinical trials) for the diagnosis of cancer. The role will be responsible for creating, implementing, managing and executing the drug development plan. The successful delivery of the development plan will require leading a cross-functional team including manufacturing, non-clinical, clinical, quality and regulatory and a strong understanding of oncology drug development.

This role is critical to the further development and successful delivery of Telix’s product portfolio by driving the current and future development of this newly acquired product.

Key Accountabilities:

• Work as part of a cross-functional team to create product development and commercialisation plans of PSMA related products.
• Lead cross-functional teams to deliver the program and product development milestones up to the end of Phase 3 clinical evaluation.
• Successful execution of all product development plans through to the end of Phase 3 clinical evaluation within project timelines and budget.
• Oversight of Project Manager to ensure application of project management best practice, with the objective of progressing the Telix product portfolio through development within project timelines and budget.
• Act as the primary point of contact for the programs and ensure that good communication is maintained both internally and externally.
• Complete oversight of the successful delivery of product development plans and product approvals, more specifically:

• • Maintenance of up-to-date documentation of product positioning and target product profile.
  • Progress tracking of all activities against the development plan and notification of potential delays and/or other changes.
  • Documentation and tracking of the Program budget; working with Finance and the project manager to ensure contracts and costs are recorded in an accurate and timely manner.
  • Work with senior management to assess product development risks and compile risk mitigation and scenario plans
  • Conducting regular reviews to ensure appropriate Program documentation is in place and to monitor project progress, scope, timelines and budget.
  • Ensuring all Program Team members and the Executive are kept informed of project status, costs and risks.
  • Supporting Project Managers in preparing periodic reports to internal stakeholders, including senior management, on the status and progress of the Program.
• Contribute to the definition and delivery of Corporate Objectives.
• Preparing timely and accurate reports for Management.
• Maintaining current awareness of Program-related scientific, clinical and commercial functional knowledge.

Education and Experience:

• Bachelor’s degree required; Master’s or PhD strongly preferred
• 10+ years’ pharmaceutical/biotechnology industry experience including direct experience in oncology drug development required
• 5+ years’ project and budget management experience
• Non-clinical through Phase 4 experience an asset
• Diagnostics experience preferred
• An understanding of the regulatory environment in the US, EU and APAC
• Experience working as part of, and managing, a cross-functional team
• Line management experience strongly 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