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Commercial Operations Director (Manufacturing) - TLX250Px

External
telixus logoTelixus · Remote
Full-timeRemote1mo ago
ComplianceCross-functional CollaborationLeadershipRisk Management
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Requirements

  • Minimum 5-7 years of leadership experience in the development, manufacturing, and commercialization of PET biomarkers or radiopharmaceuticals used in commercial operations. Deep understanding of GMP and commercial product development requirements, including 21 CFR 212 and USP compliance.
  • Strong understanding of processes and considerations unique to short half-life radiopharmaceutical products.
  • Proven experience managing external partners, CMOs, and distribution vendors, with a demonstrated ability to drive performance through KPIs and continuous improvement.
  • Travel as required to perform job responsibilities.
  • 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 excellen

Additional Information

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Commercial Operations Director-TLX101Px is responsible for leading the operational readiness and commercial execution of Telix's TLX101Px program. This role bridges strategy and execution by overseeing manufacturing, logistics and distribution initiatives that enable successful product commercialization. It requires a balance of strategic oversight and hands-on operational leadership to deliver compliant, efficient, and scalable processes. The Director will lead the implementation of the commercial distribution strategy for TLX101Px, including contract execution, process development, and the introduction of new tools and systems. They will provide data and analytics in support of finance, sales and marketing functions and serve as the primary interface for vendor, CMO, and distributor management. This includes sourcing, contracting, and performance oversight to ensure reliable, high-quality supply to customers and sufficient capacity to meet commercial and clinical demand. The successful candidate will collaborate cross-functionally with key stakeholders (including Manufacturing, Quality, Clinical, Supply Chain, Logistics, Regulatory, and Commercial) to align operational activities with business objectives. The role demands strong analytical insight, operational rigor, and collaborative leadership to ensure a seamless product launch and sustained commercial success. Key Accountabilities Operational Readiness & Launch Execution - Lead the implementation of the TLX101Px commercial distribution strategy, including vendor contracting, process development, and coordination of logistics and supply chain activities to support commercial launch. Partner with cross-functional teams on planning and execution of technical transfer activities, including site training and proficiency. Develop and refine processes for managing production challenges, operational failures, and customer support needs. Vendor & CMO Management - Establish and maintain strong partnerships with contract manufacturers, distributors, and logistics providers. Oversee performance through KPIs, business reviews, and continuous improvement initiatives to ensure reliability and compliance. Data, Systems & Analytics - Develop and maintain operational reporting tools, dashboards, and analytics that support the commercial team. Ensure data-driven visibility into manufacturing, distribution and delivery performance. Quality, Compliance & Risk Management - Partner with Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure compliance. Support audits, inspections and CAPA resolution as part of ongoing operational readiness and continuous improvement. Cross-Functional Collaboration - Work closely with Clinical, Manufacturing, Regulatory, and Commercial teams to align operational processes with strategic business goals and ensure seamless coordination across functions. Continuous Improvement & Efficiency - Identify opportunities to streamline workflows and processes, enhance vendor performance, increase geographical footprint, enhance redundancy, and optimize cost and supply chain efficiency to enable sustainable growth and scalability. Education and Experience Education: PharmD, M.S. or B.S. degree in chemistry, biology or related sciences. Advanced degree preferred.


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