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.
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