Senior Clinical Outcomes Assessment (COA/PRO) Manager – HEOR

h312-month temporary assignment | Basel | Global Pharmaceutical Company /h3 pFor a global pharmaceutical company in Basel, we are looking for an experienced bSenior Clinical Outcomes Assessment (COA/PRO) Manager /b with strong expertise in patient-centered outcomes research. /p pThis is a highly visible scientific and strategic role at the interface of bclinical development, regulatory affairs, HEOR and market access. /b You will shape COA strategies across clinical programs and ensure that outcome measures generate robust evidence for both regulatory and HTA decision-making. /p h3Your responsibilities /h3 ul liDevelop and lead Clinical Outcome Assessment (COA) strategies across therapeutic areas and clinical development programs /li liDefine COA plans, timelines and validation milestones for regulatory and HTA purposes /li liAdvise clinical development teams on the selection and implementation of appropriate Patient-Reported Outcomes (PROs) and other COA endpoints /li liProvide COA expertise for clinical trial protocols, statistical and psychometric analysis plans, clinical reports and related documentation /li liLead COA projects from strategy through execution in collaboration with internal stakeholders and external scientific partners /li liOversee content validation, psychometric validation and interpretation of COA results /li liEnsure that psychometric evidence meets scientific standards for regulatory submissions, product labelling and HTA dossiers /li liCollaborate closely with biostatistics, psychometrics, clinical development, data management, regulatory affairs, medical affairs and market access /li liLead or review COA analysis plans and scientific reports, ensuring a clear link between COA findings, clinical benefit and HTA requirements /li liContribute to regulatory interactions and submissions, including briefing documents, scientific advice and dossier content /li liSupport scientific publications, presentations and other evidence-generation activities /li liStay current with evolving COA methodologies, regulatory expectations and industry standards /li /ul pDepending on experience, the role may also include aligning COA endpoints with broader HEOR and HTA evidence needs, overseeing external vendors and participating in cross-functional COA governance. /p h3Your profile /h3 ul liMaster's degree or PhD in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics or a related scientific discipline /li liAt least 5 years of relevant experience in Health Outcomes Research, preferably within the pharmaceutical, biotechnology or consulting environment /li liProven hands-on experience in COA/PRO strategy, instrument validation and psychometric methodologies within clinical drug development is essential /li liIn-depth understanding of qualitative and quantitative COA research, instrument development, validation and interpretation /li liAbility to critically evaluate COA data and translate scientific findings into robust, regulatory-ready evidence /li liStrong understanding of global regulatory requirements and their implications for clinical outcome strategies /li liExperience with FDA and/or EMA regulatory expectations is highly desirable /li liUnderstanding of electronic COA (eCOA) implementation, including migration from paper and BYOD approaches /li liProven ability to lead complex, cross-functional projects within a global matrix organisation /li liExperience coordinating external vendors and scientific partners /li liStrong stakeholder management, communication and problem-solving skills /li liAbility to influence and collaborate effectively without direct hierarchical authority /li liProactive, collaborative and scientifically rigorous working style /li /ul h3The assignment /h3 pThis is a 12-month temporary position based in Basel, starting on 1 December 2026, within an international Big Pharma environment. /p pThe role offers the opportunity to take scientific ownership of COA strategies within complex global development programs and work closely with experts across clinical development, regulatory affairs, HEOR and market access. /p #J-18808-Ljbffr