Post-Trial Access Manager, Continued Access is accountable for the execution of multiple global PTA programs, of mild and moderate complexity, with minimal supervision. 

PTA here refers to the provision of  investigational product for the intent of treatment, in a non-trial setting and under the care of a physician, following participation in a trial. PTA by this definition is governed by local laws and regulations and may be provided by established regulatory mechanisms such as early access, named patient programs, and other pre-approval access and managed access programs.

Responsabilities

Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approvalEnsure compliance with regulatory requirements and company Policies/SOPs  Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programsPopulate PTA templates and tools with program-specific information related to investigational product access decisions and implementationDrive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as neededEnsure alignment across PTA program decisions, documentation, plans, and implementationProvide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational productsManage requests for investigational product access through PTA programs, ensuring timely and compliant processingManage vendor contracting and deliverables in support of PTA/continued access program executionUtilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programsMonitor quality, KPIs, and program performance; identify issues and escalate as neededCommunicate PTA program status, risks, and updates to stakeholdersIdentify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practicesEnsure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programsSupport other PTA/continued access activities and programs, as assigned

Requirements

BS/BA (or equivalent experience)Experience in clinical research or biopharmaceutical operations; including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval; comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be consideredExperience managing Oncology Global trialsGeneral understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical researchDemonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervisionProven experience collaborating effectively; influencing stakeholders across functions and levelsEvidence of strong project management skills; including managing competing priorities and solving operational challenges in clinical or investigational program environmentsSuccessful history of working independently in a global environmentExperience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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