PCOR Lead Rare Diseases
Raleigh, NC 
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Posted 13 days ago
Job Description
JOB DESCRIPTION

Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?


To strengthen our Patient Centred Outcomes Research (PCOR) Team within Rare Disease Organization, Development Solutions, based either in Brussels (Belgium), Slough (UK), Monheim (Germany), or Raleigh (US) we are looking for a talented individual to fill the position of: PCOR Lead


The PCOR Lead is responsible for the evaluation of patient needs and lead the development and inclusion of patient relevant outcome measures to demonstrate the unequivocal evidence of patient benefits of the innovative UCB patient solutions to decision makers. The choice and development of these measures will be strongly driven by what matters most to people living with severe disease, and augment traditional regulatory endpoints and assist in both regulatory approval and demonstration of value for acceleration of patient access to these 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 for projects from Early Development through to full lifecycle management.
  • Managing mixed methods research (qualitative and quantitative research) required to support the selection, development, and validation of PRO/COA measures


You will contribute by:

  • 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.
  • Prepare relevant sections of strategic documents and communications for regulatory agency meetings, support and/or participate in meetings with regulatory agencies; and provide robust documentation of COA evidence in support of submission activities
  • Contribute to the publication strategy to enhance communication of value from the patients perspective , including-preparing abstracts and manuscripts, presenting COA results from clinical studies as well as COA/PRO 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.
  • Being a passionate and inspiring ambassador for the PCOR Team and promote the value proposition of PCOR Team to quantitative and qualitative PRO/COA and/or patient preference studies across the organization and establish an industry leadership position.
  • Driving the creation and delivery of education on PRO/COA measures and/or Patient preference studies for internal business partners.
  • 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.
  • 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., PRO Consortium EuroQol Group, ISPOR working groups etc.).

Interested? For this position you'll need the following education, experience and skills:

  • Relevant academic background (min MA/MSc)
  • Awareness of policy development and execution
  • have 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.
  • The individual will offer PRO expertise and 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.
  • The candidate must possess the skills and ability to clearly communicate findings and recommendations in an analysis plan or study report.
  • display strong project and people leadership, project management, communication and stakeholder management skills.
  • ensure that priority targets are met, a strategic vision is maintained, anticipate how best to generate evidence to answer key questions in the minds of our stakeholders and that appropriate internal or asset-specific measures are taken to ensure optimum responsiveness to the evolving PRO landscape.
  • Strong cross-functional collaboration skills in a matrix environment
  • Advanced stakeholder management skills
  • Advanced influencing skills
  • Strong external engagement and networking skills

Why you should apply


At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you'll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees - just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

About UCB in Rare Diseases

We're driven by patient value, not patient numbers.

People with rare diseases often feel forgotten, unheard or misunderstood. The challenges they face can be magnified by isolation, and they may wonder if anyone else cares about what they need. They worry their disease affects too few people for anybody to care.

The greatest needs can't always be measured in numbers. At UCB, we don't just see patients or population sizes, we see people in need. Through decades of serving the neurology and immunology communities, we have improved lives with impactful medicines and by enhancing the social and emotional well-being of patients. As a continuation of our heritage, and a progression of our science, we are expanding our efforts to developing treatments for rare neurological and immunologic diseases where current options offer little hope. We believe our scientific strength in these fields can create genuine value for the patient communities we serve.

Curious to know more? Please visit our website .

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer.


About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: "How will this create value for people living with severe disease?". We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website .

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.


UCB and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer. Minority/Female/Disability/Veteran

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
5+ years
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