Global Product Development Lead - PSMA

Role Summary

Global Product Development Lead - PSMA is responsible for the successful development of diagnostic products for cancer up to Phase 3 clinical trials. You will create, implement, manage and execute the drug development plan and lead a cross-functional team across manufacturing, non-clinical, clinical, quality and regulatory. This role drives the development of PSMA-related products and ensures milestones are met within timelines and budget.

Responsibilities

• 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.

Qualifications

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

Skills

• Inclusive mindset
• Creativity and innovation
• Commitment to excellence
• Results-oriented
• Ethical behavior
• Adaptability
• Strong communication skills
• Collaboration
• Resilience
• Continuous learning

Education

• Bachelor’s degree required
• Master’s degree strongly preferred
• PhD preferred