Post-Trial Access Manager, Continued Access - Sponsor DedicatedBarcelona, Spain | Full time | Home-based | R1546701Post-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.Responsibilities- Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval- Ensure compliance with regulatory requirements and company Policies/SOPs- Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs- Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation- Drive 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 needed-Ensure alignment across PTA program decisions, documentation, plans, and implementation- Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products- Manage requests for investigational product access through PTA programs, ensuring timely and compliant processing- Manage vendor contracting and deliverables in support of PTA/continued access program execution- Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs- Monitor quality, KPIs, and program performance;
identify issues and escalate as needed- Communicate PTA program status, risks, and updates to stakeholders- Identify risks and implement mitigation strategies specific to investigational product access and program continuity;
capture lessons learnedand best practices- Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs- Support other PTA/continued access activities and programs, as assignedRequirements- 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 considered- Experience managing Oncology Global trials- General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research- Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision- Proven experience collaborating effectively;
influencing stakeholders across functions and levels- Evidence of strong project management skills;
including managing competing priorities and solving operational challenges in clinical or investigational program environments- Successful history of working independently in a global environment- Experience 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.#J-18808-Ljbffr