PATIENT-CENTERED OUTCOMES RESEARCH LEAD

We are excited to partner with a leading multinational pharmaceutical company, renowned for its innovation and global reach, in the search for a Patient-Centered Outcomes Research (P-COR) Lead. This key role will be based at their HUB in Barcelona, where Research & Development is a top priority.As the P-COR Lead, you will be responsible for overseeing clinical outcome assessment (COA) activities across a diverse range of therapeutic areas within the organization, championing a patient-first approach. You will play a critical role in ensuring that the company’s clinical programs and products are strategically informed by a comprehensive COA strategy, focusing on patient-centred outcomes to drive commercial success.This high-profile position requires expertise in COA strategic planning, along with a commitment to scientific integrity and impact. You will collaborate with both internal cross-functional teams and external partners to ensure the effective execution of COA initiatives, including patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), and other COA assessments. Your leadership will be key to the successful implementation and advancement of these vital projects, ensuring they are seamlessly integrated into the company’s clinical program.Objective and Purpose of the Position Optimize the patient experience throughout the clinical journey, from trial design to final reporting. As the leader of COA-related projects, you will drive patient-centered clinical design and actively identify key regulatory or market access requirements necessary for the clinical program’s success. The aim is to ensure the commercial and regulatory success of products by incorporating COAs into their endpoint measurement strategies across all stages of the clinical lifecycle.Key Tasks and Responsibilities Lead the development, creation and execution of strategic clinical outcome assessment (COA) plans for products in all therapeutic areas.Guide internal teams for clinical programs in choosing the appropriate COAs for clinical trials and provide input into the majority of clinical documents, throughout the clinical trial lifecycle.Lead the scientific execution of COA projects from start to finish with outside vendors and internal stakeholders.Provide guidance and direction to project teams, ensuring adherence to COA specific regulatory requirements, best practices and industry standards related to COAs, including advising the scientific rigor for translation, cultural adaptation and electronic COA implementation activities within trials.Oversee and own COA content validation and psychometric validation activities, analyses and outputs.Work with biostatisticians/psychometricians, clinical and data management teams to interpret and report COA data and prepare and submit regulatory or scientific documents.Lead in preparing relevant sections of meetings, documentation and communication for regulatory agencies or manuscripts in support of communication and commercial product goals with other cross-functional teams.Stay up to date with COA related leading scientific organizations and bodies and recent methodologies.Professional Background At least a master’s degree in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics, or a related field. Ph.D. is preferred.Minimum of 5 years of applied experience and leadership in health outcomes research, ideally in the COA/PRO area.In-depth knowledge of COA methodologies and regulatory requirements.Strong ability to understand and analyze COA data, apply COA validation methodologies and output for qualitative and quantitative COA research methods.Strong ability to develop strategies and implement tactics for optimal clinical outcome strategy.Excellent leadership and communication skills, collaboration and communication skills to ensure implementation of COA strategies.Understanding of electronic COA migrations from paper, BYOD and/or latest eCOA implementation standards.Proven experience in successfully interacting with multiple stakeholders internally and externally.High degree of empathy and inclusive mindset to work with diverse external stakeholder groups.Collaborate effectively without hierarchical authority and with accountability, proactive and inclusive.What we offer Unique opportunity to be part in the forefront of innovation with a global leader in the pharmaceutical industry.Key role in shaping the strategic direction of COA, with a strong focus on patient-centered outcomes.Competitive salary package complemented by attractive benefits.Work flexibility with a strong offer to work from home in order to maintain a healthy work-life balance.