Expanded Access Manager / Post-Trial Access Specialist - FSP - UK

Work Schedule

Environmental Conditions

Job Description

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. We are seeking an Expanded Access Manager / Post-Trial Access Specialist (Oncology) to provide operational leadership and guidance for managed access programs, including compassionate use, expanded access and post-trial access.

In this role, you will build strong relationships across clinical operations, medical affairs, supply, finance, governance and other cross-functional teams, while supporting effective communication with healthcare professionals, vendors and other external stakeholders.

A Day in the Life

• Set up and manage operational support for post-trial managed access programs from planning through close-out, including budget coordination, clinical trial management systems, vendor communications, investigational product stock and delivery, and tracking of documents, agreements, contracts and key correspondence.

• Collaborate with clinical study teams to assess feasibility, regulatory requirements, logistical plans and supply mechanisms for managed access following the close of sponsored clinical trials.

• Partner with global and local medical affairs, clinical operations and cross-functional stakeholders to deliver post-trial managed access programs.

• Provide day-to-day coordination to support continuity of access for post-trial patients.

• Coordinate program status tracking, investigational product management, document management and data review activities in accordance with applicable regulatory requirements and Good Manufacturing Practice.

• Manage vendors supporting program execution.

• Coordinate expanded access activities, including document collection, filing and archiving, and tracking timelines and metrics to support timely, high-quality delivery.

• Provide regular program status and utilization updates to relevant stakeholders.

• Collaborate with CMC and other functional areas to support clinical supply planning and forecasting as requested by program leads.

• Develop project materials and tools that enable effective operationalization and communication.

• Proactively identify delivery issues and risks, coordinate corrective actions when deviations occur and communicate appropriately with stakeholders.

• Track key milestones and timelines and contribute to program initiatives and process improvements.

Keys to Success

• Proven ability to work effectively in cross-functional teams and contribute to shared goals.

• High level of integrity, accuracy and attention to detail.

• Strong organizational, prioritization and project management skills, with the ability to deliver assignments on time and within budget.

• Strong problem-solving skills and sound judgment in an environment where priorities may evolve.

• Excellent written and verbal communication skills, with the ability to work effectively with stakeholders at different levels and across functions.

• Self-motivated, resourceful and results-oriented, with the ability to work with urgency in a fast-paced environment.

• Understanding of cross-functional responsibilities across areas such as Supply Chain, Regulatory, Pharmacovigilance, Legal, Medical Writing and local medical teams.

Education

Bachelor’s degree in a scientific or clinical discipline, or equivalent relevant education and experience.

Experience

• At least 3 years of relevant experience in the pharmaceutical, biotechnology, clinical research or CRO industry.

• Direct experience in clinical research or managed access, for example as a study manager, Clinical Research Associate (CRA), project manager or in a comparable role.

• Working knowledge of compassionate use, early access or expanded access programs.

• Experience managing compassionate use, early access or post-trial access programs is preferred.

• Oncology experience is preferred.

• Prior clinical project management or expanded access program experience is preferred.

Knowledge, Skills and Abilities

• Ability to coordinate multiple workstreams, stakeholders, vendors and deliverables.

• Ability to interpret operational and regulatory requirements and translate them into practical program plans.

• Comfort working with ambiguity and making thoughtful, timely decisions within the scope of the role.

• Ability to communicate risks, status, timelines and actions clearly to internal and external stakeholders.

• Commitment to quality, compliance and continuous improvement.

About Thermo Fisher Scientific

Thermo Fisher Scientific is committed to enabling our customers to make the world healthier, cleaner and safer. Join our team and help bring our Mission to life through work that supports patients, customers and colleagues around the world.

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.