Global Product Development Lead - TLX102

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The Global Development Lead will be responsible for progressing a molecularly targeted radiation (alpha) therapy through clinical trials up to and including Phase 2. 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 will need a strong understanding of oncology drug development.
This role is critical to accelerate the delivery of a therapy for an unmet medical need towards registration.

Key Accountabilities:

• Work as part of a cross-functional team to create/manage a Target Product Profile and Product Development plan for the targeted therapy in solid tumours.
• Lead cross-functional teams to deliver the program development milestones up to the end of Phase 2 clinical evaluation within project timelines and budget.
• Act as the primary point of contact for the program and ensure that excellent communication is maintained both
• internally and externally.
• Oversight of a Project Manager to ensure application of project management best practice.
• Complete oversight of the delivery of product development plans, 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
  • Conduct 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.
• Represent the program team at internal and external meetings

Education and Experience:

• Postgraduate qualifications in science or life sciences (ideally PhD) required
• 8+ years’ pharmaceutical/biotechnology industry experience including direct experience in drug development (ideally in oncology) required
• 3+ years’ project and budget management experience
• An understanding of the regulatory environment in the US, EU and APAC pertaining to drug development
• Experience working as part of, and also managing, a cross-functional team

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
• Attention to Detail: Have a strong attention to detail and be able to pick up errors before they become issues whilst also maintaining a helicopter view and be able to prioritise