Director, Commercial Lead Gene Therapy, EMEA

Position Summary:

As the Director, Commercial Lead, EMEA for your assigned Gene Therapy products, you are the key Point of Contact for the products prior to, during and post launch. You are the owner of the product launch strategy, plan and execution for EMEA and the single point of contact for the Product (Global, Countries, EMEA functions).  

In this pivotal role, you will lead regional cross-functional brand teams, develop above-market regional and local launch plans, and drive strategic initiatives to ensure launch readiness, market access, and P&L optimization. 

This role requires a deep understanding of the complexities involved in launching gene therapies, including regulatory, supply chain, and access challenges unique to these modalities. 

ultrainnovative – Tackle rare and dynamic challenges

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

End-to-End Launch Strategy & Execution 

• Lead the development and execution of a comprehensive EMEA pre-launch, launch, and post-launch strategy for gene therapy assets in collaboration with Global Commercial and EMEA cross functional team. 
• Translate global strategy into regional and local launch plans, tailored for market-specific needs and regulatory frameworks across EMEA. 
• Partner closely with General Managers, and country teams to guide local cross-functional launch readiness teams, build capabilities, and gather insights to co-develop launch plans. 

Cross-Functional Leadership & Governance 

• Lead in the Matrix organization the cross-functional regional launch team, including Commercial, Medical, Market Access, Regulatory, Supply Chain, Quality, and Patient Advocacy to ensure a coordinated, timely and high-quality launch. 
• Establish and lead EMEA Gene Therapy Launch Governance, including launch readiness reviews, operational dashboards, and cross-functional checkpoints. 
• Coordinate internal milestone planning and ensure visibility of interdependencies between regulatory timelines, launch sequence, supply readiness, and country-specific access paths. 
• Working with the Global team to align on the Launch sequence for the EMEA region taking into consideration the reference pricing implications for each country and rest of world and work with Market Access on the net pricing strategy and implications on the revenue for this product across the Region.  
• Serve as the primary EMEA representative to Global Launch Governance forums and escalate region-specific barriers to resolution. 

Commercial and Gene Therapy Operational Readiness 

• Own the commercial readiness strategy, ensuring seamless integration of operational, regulatory, and market needs. 
• Work with the Cross Functional Team to design the Go to Market model and Site Selection and Readiness approach during pre launch, launch and ongoing expansion 
• Support the design and implementation of gene therapy market access strategies to optimize patient access, payer engagement and pricing. 
• In collaboration with Business Operations and Technical Operations, align supply chain and logistics readiness, particularly in light of Gene Therapy handling particularities  
• In collaboration with Business Operations and Medical Affairs ensure operational readiness to qualify and activate treatment sites 

Performance Monitoring & Continuous Improvement

• Define and track launch KPIs and leading indicators at the regional and country level. 
• Drive performance management through readiness and performance reviews, and lead course correction strategies where needed. 
• Develop a lessons-learned framework to share best practices and inform future gene therapy launches. 

Project & Budget Management 

• Drive strategic above-market projects to support launch readiness and market success. 
• Manage budgets effectively to align with organizational priorities and launch timelines. 
• Support the VP Commercial, EMEA Business Operations Lead and Finance in budget planning, forecasting, and leadership reporting. 

Launch Readiness Execution and Best Practice Sharing 

• Lead launch readiness meetings, ensuring all stakeholders are aligned on goals and progress. 
• Identify and address risks, bottlenecks, and challenges proactively to maintain momentum. 
• Lead regular best practice sharing forums to ensure optimal lessons learned and capability sharing across countries and across the globe

Requirements:

Education 

• Bachelor’s degree in Business, Life Sciences, or a related field  
• Advanced degree such as MBA or MSc preferred 

Skills and Competencies 

• Strategic thinker with a deep understanding of launch planning frameworks and operational execution in highly complex, cross-functional settings. 
• Exceptional leadership and stakeholder management skills in a matrixed, multicultural environment. 
• Excellent project management, communication, and analytical skills. 
• Ability to anticipate and solve complex challenges with agility and strategic foresight. 

Experience 

• 10+ years of pharmaceutical or biotech experience, including proven success launching products across multiple markets in EMEA. 
• Experience launching cell or gene therapies strongly preferred. 
• Rare or ultra-rare disease experience highly desirable. 
• Strong understanding of the complexities of end-to-end supply of Gene Therapies preferred. 
• Demonstrated experience with EMEA pricing, access (including early access), and regulatory environments, ideally in advanced therapy medicinal products (ATMPs). 

Physical Demand Requirements:  

• Travel: As required to ensure launch optimization in countries and to enable best practice sharing  
• Full compliance with Ultragenyx policies, industry regulations, and applicable laws is required. 

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