Patient Centric Outcomes Research Lead 1
Date: Aug 13, 2019
Location: Anderlecht, Brussels, BE
Patient Centered Outcomes Research Lead
Global Clinical Development
August 13, 2019 * Location: Brussels, Belgium
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 Global Clinical Development Team, based in our headquarter in Brussels, Belgium, we are looking to fill the position of: Patient Centered Outcomes Research Lead.
Is your analytical adeptness second only to your strategic capacities? At UCB, we know you as a 'stratelytical' person. This specific blend of talent means you are a deep-thinking planner devoted to improving patients' lives.
As a UCB 'stratelytical' person and Patient Centered Outcomes Research Lead you like to work in an environment where you can:
* Be responsible for the evaluation of patient need in areas of interest, lead the development and inclusion of patient relevant outcome measures that provide the required sensitivity and specificity to demonstrate the unequivocal evidence of patient benefits of innovative UCB solutions and assist in value demonstration towards regulatory approval and acceleration of patient access. These PRO/COA (clinical outcome) 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.
As a UCB 'stratelytical' person and Patient Centered Outcomes Research Lead you will contribute by:
* As the key contributor of PRO/COA content in clinical programs, leading the development and implementation of optimal PCOR strategic and tactical plans as part of the Integrated Evidence Plan for projects from New Meds through to full lifecycle management. This includes managing research required to support the selection, development, and validation of PRO/COA measures, including qualitative and quantitative 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 subject matter 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 trials 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
* Being a passionate and inspiring ambassador for the PCOR Team and promote the value proposition of PCOR Team to quantitative and qualitative PRO and/or patient preference studies across the organization and establish an industry leadership position.
* At direction of the Head of PCOR and in collaboration with External Engagement Practice and Global Regulatory Affairs Policy & Intelligence group, 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 Master degree
* At least 3-5 years of 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 and patient preference studies.
* Profound 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/ experience with, instrument development to support labelling claims in the US, EU and Japan/China.
* Strong leadership, project management, communication and stakeholder management skills.
* Strong cross-functional collaboration skills in a matrix environment; Ability to co-create and implement innovative development programmes.
* Strong External engagement, networking and influencing skills
* Knowledge of the clinical development process and appreciation of scientific content of clinical programs.
* Knowledge of Payer systems.
* Awareness of policy development and execution and study preference methodology
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