Help us transform patients' lives.
At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
To strengthen our Patient Centred Outcomes Research (PCOR) Team within Global Clinical Development , based either in Monheim (Germany), Brussels (Belgium), Slough (UK) or Raleigh (US) we are looking for a talented individual to fill the position of: PCOR Lead
The PCOR lead is responsible for evaluation of patient needs in therapeutic areas of interest and to lead the selection, development and inclusion of patient relevant outcome measures that provide the required sensitivity and specificity to be able to demonstrate the unequivocal evidence of patient benefits of the innovative UCB patient solutions.
You like to work in an environment where you can: Be a key contributor of PRO/COA content in clinical programs, Lead the development and implementation of optimal PCOR strategic and tactical plans as part of the Integrated Evidence Plan for projects from Early Development through to full lifecycle management. Managing research required to support the selection, development, and validation of PRO/COA measures, including qualitative research.
Providing protocol and clinical study report language, analysis plans, and guides for interpretation of findings. Maximizing the impact of evidence of treatment benefit generated by PCOR measures by providing expert input to regulatory and HTA briefing packages, publication strategies, clinical development, regulatory and market access strategy and submission documents. Preparing relevant sections of documents and communications for regulatory agency meetings, support and/or participate in said meetings at regulatory agencies and provide robust evidence in support of submission activities. Preparing abstracts and manuscripts presenting PRO/COA results from clinical studies as well as PRO/COA development and validation studies, in line with agreed upon publication strategy. Driving the wider organizational awareness and change management of UCB’s appreciation of the relevance of PCOR evidence generation and the consideration of use and development of appropriate tools as early as possibly in development. Building robust relationships with external groups including patient groups, payers, policy makers and influencers and establish a partnership in providing new methodological frameworks and tools that lead to wider acceptance of the use of PCOR tools in evidence review and external decision making.
You will contribute by:
Interested? For this position you’ll need the following education, experienc e and skills : Relevant academic background (min MA/MSc) 5+ years of PCOR SME experience working within biopharmaceutical/ medical device companies and/or academia, experience in PRO development and validation, PRO instrument assessment and selection, and other disciplines relevant to PRO studies. experience in clinical trial study design, selection of screening tools, development of study protocols and statistical analysis plans, collection and analysis of study data, and have an interest in, or experience with, instrument development to support labelling claims in the US, EU and Japan/China.
calendar_todayil y a 21 heures