The Role:

The Expanded Access Program Manager is responsible for the successful delivery of assigned programs from award through to close-out, ensuring all client expectations are met or exceeded. Acting as the primary point of contact for pharmaceutical and biotech partners, you will lead cross-functional teams to design, implement, and manage Expanded Access and exclusive distribution programs in line with global regulatory and GDP requirements.

You will oversee all aspects of program operations, including contract management, onboarding of clients and products, process development, vendor oversight, performance tracking, and client reporting. This role requires strong leadership, strategic insight into drug development lifecycles, and the ability to identify opportunities to expand services within existing accounts. You will be accountable for delivering key performance indicators, maintaining compliance, and ensuring a best-in-class service for patients, clients, and internal stakeholders.

Main Responsibilities

• Entire life-cycle program delivery from program award to close out.
• Full accountability and responsibility for success of the program in accordance with client expectations.
• Be the primary point of contact for client companies with whom we partner for the provision of their Exclusive Access Programs (Expanded Access and exclusive distribution programs) and have overall accountability for program delivery.
• Lead a cross-functional program team comprising stakeholders across Uniphar Group for the design, implementation, and delivery of EAPs.
• Upon award of the program ensure all necessary contracts and agreements (Master Services Agreements, Statements of Work, Quality Technical Agreements, Data Processing Agreements, Safety Data Exchange Agreements, and others as required) are in place.
• Take full accountability for the deliverables and Key Performance Indicators committed to for the assigned program.
• Onboard the client, their manufacturer, and product(s) within the relevant Uniphar Group companies.
• Be the advocate for assigned clients within Uniphar Group to ensure a best-in-class service is delivered throughout the program life cycle.
• Collaborate with internal teams including regulatory, supply chain, quality, and technical to ensure client requirements are implemented into the program in line with global regulatory requirements.
• Design, write, and implement program-specific processes and be accountable for processes being followed by the project team.
• Management of third-party vendors who are responsible for delivering a service for client programs.
• Maintain communication with the client, in line with the agreed program communication plan. This will include weekly and monthly meetings in addition to ad hoc communication.
• Manage scope changes throughout the program by receiving and understanding a request from the client, assessing contractual and operational implications, and progressing as required with support from the internal cross-functional team.
• Have accountability for all program reporting requirements, at a time and frequency as agreed with the client.
• Delivery of Key Performance Indicators, including budgetary targets, as well as account relationship development objectives.
• Understand the client’s plans for the asset in the context of the drug development and launch process to be able to predict, plan, and execute transitions within the program.
• Identify opportunities for developing new business from existing clients with the Uniphar Group capabilities in mind.
• To carry out the relevant GDP SOPs as instructed by the RP of the Company.