Sr Director, Product Development Lead - 591

See Yourself at Telix

The Sr Director, Product Development Lead is entrusted with owning and leading the global development of late-stage radiopharmaceutical compounds for therapeutic oncology indications. This role provides cross-functional leadership across clinical, regulatory, CMC, quality, manufacturing/supply chain, and commercial, and drives governance, decision-making, and risk management to deliver program milestones and support regulatory interactions and approvals. This role may include direct people management of one or more Project managers. As a strategic thinker and clear communicator, the role requires a hands-on approach to aligning stakeholders, maintaining an execution-ready integrated plan, and presenting program status, risks, and recommendations to senior leadership.

Key Accountabilities:

• Development Leadership: Lead the Global Program Leadership Team (GPLT) and hold accountability for cross-functional commitments across CMC, Clinical, and Regulatory. Set and communicate GPLT program objectives in alignment with the Tx BU objective cascade model, ensuring clarity on shared program outcomes vs. functional objectives. Develop and maintain the Global Development Plan (GDP) and Target Product Profile (TPP), ensuring these remain current and drive aligned decision-making across the matrix team.
• Strategic Direction: Showcase courage in strategic thinking, guiding matrixed teams through complex decision-making and risk management processes.
• Cross-functional Collaboration: Foster a collaborative spirit, working seamlessly with teams spanning clinical, non-clinical, regulatory affairs, quality, manufacturing and supply chain, commercial, medical affairs and program management to formulate plans that achieve program milestones and objectives.
• Program Governance & Change Management: Drive integrated cross-functional planning and confirm readiness for key milestones and inflection points; ensure scope, timeline, and budget impacts are assessed and elevated appropriately for leadership review (e.g., Product Management Committee) and that decisions are documented and communicated.
• Risk Ownership & Communication: Identify, assign ownership of, and actively manage program risks/issues; communicate risks, mitigations, and decisions clearly to stakeholders and leadership.
• Budget Planning & Forecasting: Lead program-level budget planning and forecasting in partnership with Finance and functional leads; monitor spend vs. plan, surface variances, and drive timely re-forecasting and trade-off recommendations to support portfolio decisions.
• Regulatory Pathway Design: Partner with Clinical and Regulatory Affairs to craft the ideal development pathway for approval, aiming to meet product attributes and commercial objectives.
• Regulatory Interactions & Communication Alignment: Lead cross-functional preparation for key health authority interactions (e.g., FDA Type B), ensuring consistent internal communication, clear objectives, aligned messaging, and timely delivery of high-quality briefing materials and responses.
• Executive-Ready Program Reporting: Maintain clear, decision-focused reporting (dashboards, milestone tracking, red/amber/green risks) and ensure critical risks are visible to appropriate leadership teams with recommended actions and owners.
• Development Planning: Create and execute comprehensive product development plans and data packages, paving the way for informed go/no-go decisions and continuous progression towards product approval.
• CMC/Supply & Vendor (CDMO) Alignment: Partner with Technical Operations, Quality, and external vendors to ensure manufacturing readiness, GMP compliance, and supply continuity; proactively identify constraints and develop mitigation plans that protect clinical execution and regulatory commitments.
• Stakeholder Engagement: Engage subject matter experts and thought leaders, both within and outside the organization, fostering rich scientific dialogue, extracting insights, and refining development plans and strategies.
• Global Study Execution & Enrollment Enablement: Collaborate with Clinical Operations and regional teams to anticipate recruitment risks (including competing trials), support site activation strategy, and drive actions that protect enrollment and global data consistency.
• Inclusive Leadership & Communication: Foster an inclusive, respectful team culture, including use of inclusive language in communications and reinforcement of constructive cross-functional collaboration.

Education and Experience:

• Master’s or PhD in medical, pharma or biotech field strongly preferred; 12+ years in pharma/biotech required.
• Minimum of 5+ years leading cross-functional product teams within the pharma/biotech domain.
• Prior experience in oncology development and/or radiopharmaceuticals will be a distinct advantage.
• Experience in clinical Phase 2, Phase 3 and through approval required, specifically in the therapeutic area assigned.
• Demonstrated ability to think strategically, communicate effectively, and collaborate in a matrixed team environment.
• Direct people management experience is considered an advantage.

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