Commercial Operations Director - TLX101Px

Role Summary

Lead the operational readiness and commercial execution of the TLX101Px program, overseeing manufacturing, logistics and distribution to enable successful product commercialization. Bridge strategy and execution with vendor/CMO management, sourcing, contracting, data analytics support, and cross-functional coordination to deliver compliant, efficient, and scalable processes.

Responsibilities

• 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.

Qualifications

• Required: PharmD, MS or BS degree in chemistry, biology or related sciences. Advanced degree preferred.
• Required: Minimum 5-7 years of leadership experience in the development, production, 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.
• Required: Strong understanding of processes and considerations unique to short half-life radiopharmaceutical products.
• Required: 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.

Skills

• 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

Education

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

Additional Requirements

• Travel as required to perform job responsibilities.