Job title:
PCOR Lead
Company
UCB
Job description
Make your mark for patientsWe are looking for a Patient Centred Outcomes Research (PCOR) lead who has passion for patient experience data generation and has strong analytical and organizational skills to join us in our Global Patient Centred Outcomes Research team, based in our HQ in Brussels Belgium or in Slough, UK or Monheim, GermanyAbout the roleThe PCOR lead is responsible for evaluation of patient unmet needs in therapeutic areas of interest and to lead the 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. These COA/PRO measures will be strongly driven by local access needs and describe the patient experience, augment traditional regulatory measures and assist in both regulatory approval and demonstration of value for acceleration of patient access.Who you’ll work withThis role will report into the head of Patient Centred Outcomes Research and will join a team of subject matter experts in this area, working across the portfolio of UCB. They are caring, passionate and dedicated to deliver the best for our patients.What you’ll do
- As the key contributor of COA/PRO 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. This includes managing research required to support the selection, development, and validation of COA/PRO measures, including quantitative and qualitative research.
- Contribute to the scientific review, and development of PCOR sections of clinical study protocol and clinical study report, analysis plans, and guides for interpretation of findings.
- Maximize 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.
- Prepare relevant sections of strategic 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.
- Contribute to the publication strategy to enhance communication of value from the patient perspective, including abstracts and manuscripts presenting PRO/COA results from clinical trials as well as COA/PRO development and validation studies.
- Drive the wider organizational awareness and change management of UCB’s appreciation of the relevance of science-based patient experience evidence generation and the consideration of use and development of appropriate tools in a timely manner to be implemented in clinical development.
- Be a passionate and inspiring ambassador for the PCOR Team and promote the value proposition of PCOR team to quantitative and qualitative COA / PRO and/or Patient Preference studies across the organization and establish an industry leadership position, through external engagements with scientific/methodological bodies.
- Build robust relationships with external groups including patient advocacy groups, HTA bodies, payers, policy makers and influencers, in partnership with internal stakeholders, especially relating to new methodological frameworks and tools that lead to wider acceptance of the use of PCOR tools in evidence review and external decision making.
- At direction of the Head of PCOR and in collaboration with External Engagement and Global Regulatory Affairs, participate in global external collaborations regarding policies, evidentiary standards, and use of PRO measures (e.g., C-PATH PRO Consortium, EuroQol Group, ISPOR, ISOQOL working groups etc.).
Interested? For this role we’re looking for the following education, experience and skills
- Master / PhD in scientific field
- should have at least 3-5 years of PCOR SME experience working within biopharmaceutical/ medical device companies and/or academia with experience in PRO / COA development and validation, COA / PRO instrument assessment and selection, and other disciplines relevant to COA / PRO studies or patient preference studies.
- The individual will offer expertise in generation of science-based patient experience data and experience in clinical study design, selection of 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. The candidate must possess the skills and ability to clearly communicate findings and recommendations in an analysis plan or study report.
- Knowledge of COAs; development, validation, selection, implementation, and interpretations
- Deep understanding of the clinical development process and appreciation of scientific content of clinical development programs
- Knowledge of global HEOR approaches
- Knowledge of payer and HTA systems across regions
- Knowledge of Patient Preference methodology
- Awareness of policy development and execution
- Excellent communication skills
- High quality presentation skills
- Strong cross-functional collaboration skills in a matrix environment
- Ability to co-create and implement innovative programs
- Advanced stakeholder management skills
- Advanced planning and project management skills
- Advanced influencing skills
- Strong external engagement and networking skills
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Expected salary
Location
Slough, Berkshire
Job date
Thu, 01 Aug 2024 04:52:04 GMT
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