Commercial Operations Director – TLX250Px

Role Summary

The Commercial Operations Director-TLX250Px leads the operational readiness and commercial execution of the TLX250Px program, bridging strategy and execution across manufacturing, logistics, and distribution to enable compliant, efficient, and scalable processes. The role leads the implementation of the commercial distribution strategy, vendor/CMO management, data and analytics, and serves as the primary interface for supplier management to ensure reliable supply and capacity to meet commercial and clinical demand. It requires strong analytical insight, operational rigor, and collaborative leadership to deliver a successful product launch and sustained commercial success.

Responsibilities

• Operational Readiness & Launch Execution – Lead the implementation of the TLX250Px 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. Lead the development, implementation and launch of a capacity and dose ordering tool to support operational visibility, customer ordering, and future scalability.
• Vendor & CMO Management – Establish and maintain strong partnerships with contract manufacturers, distributors, and logistics providers across a complex, multi-site supply chain network. 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.

Qualifications

• Required: 5-7 years of leadership experience in the development, production, and commercialization of PET biomarkers or radiopharmaceuticals used in commercial operations.
• Required: Deep understanding of GMP and commercial product development requirements, including 21 CFR 212, 211, 210 and USP compliance.
• Required: Strong understanding of processes and considerations unique to radiopharmaceutical products.
• Required: Proven experience managing external partners, CMOs, and distribution vendors, with a demonstrated ability to drive performance through KPIs and continuous improvement.
• Required: Experience coordinating or managing complex radiopharmaceutical supply chain network.
• Preferred: Advanced degree (PharmD, MS, or BS) in chemistry, biology or related sciences.

Education

• PharmD, MS or BS degree in chemistry, biology or related sciences. Advanced degree preferred.

Skills

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

Additional Requirements

• Travel as required to perform job responsibilities.