Pcor Lead - Slough, United Kingdom - UCB S.A.

UCB S.A.
UCB S.A.
Verified Company
Slough, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Make your mark for patients
We are looking for a
Patient Centered Outcome Research (PCOR) lead who is expert in PRO studies with strong analytical and organizational skills to join us in our
Global Patient Centered Outcome Research team team, based in our
HQ in Brussels Belgium or in Slough, UK

About the role


The 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 with


This role will report into the head of Patient Centered Outcome Research and will join a team of experts in this area, working over the complete portfolio of UCB.

They are caring, passionate and dedicated to deliver the best for our patients. Internally this role will operate externally with patient advocacy groups, HTA bodies, payers, policy makers and influencers, in partnership with internal stakeholders


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 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 PCOR 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.
  • Drive the creation and delivery of education on COA/PRO measures and/or Patient Preference studies for internal business partners to enhance the collection and dissemination of PCOR data
  • 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 COA 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 development and validation, PRO instrument assessment and selection, and other disciplines relevant to PRO studies or patient preference studies.

  • 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
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