Site Name: UK - London
Brentford, USA - Massachusetts
Posted Date: Apr 10 2020
As a Senior Scientist of Patient-Centered Outcomes for Oncology you will apply specialized technical expertise in support of GSK's exciting oncology portfolio to support Patient Reported Outcomes (PRO) / Clinical Outcome Assessment (COA) strategies.
Our work in oncology is complex, but our goal is simple: transformational medicines to improve survival and potentially achieve cures. We're seeing promising results in our oncology work, where we focus on improving outcomes and outpacing the cancers we fight.
Our portfolio focuses on four cutting edge areas of science:
We believe that our approach of developing a pipeline of transformational products that fight cancer on multiple ground-breaking fronts will deliver a sustainable flow of innovative treatments for patients with the potential to have transformative effects on their disease.
GSK's Patient Centered Outcomes (PCO) team has an integral role in in the development of integrated evidence plans to ensure that strong COA strategies support a patient-centric understanding of our oncology medicines. Our mission is to deliver 'do more, feel better' by implementing strong measurement science to capture the patient voice in demonstrating the value of our products to patients, physicians, payers and regulators. GSK's PCO team includes 10 directors, scientists and COA implementation specialists. The team has educational backgrounds across a range of COA disciplines and experience in pharmaceutical, regulatory and academic settings. We work in close partnership across GSK functions including clinical development, regulatory affairs, value evidence and outcomes and patient focused drug development. We are well connected with external initiatives to define, implement and interpret patient centric endpoints in drug development.
We want to ensure that we have a focused view of our overall goals for the value of patient centric outcomes in oncology. We want to ensure that each development program has a well-characterized innovative COA strategy with plans to develop evidence supporting those endpoints. We build rigor into implementation of PROs into our clinical trials.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Define and implement strategies for development and implementation of PRO/COAs across GSKs oncology portfolio
Develop global COA endpoint strategic plans to assure alignment with product goals;
Effectively communicate and execute COA strategies, assuring alignment with clinical, health outcomes and commercial strategies and overall clinical development plan
Coordinate and lead the development, validation, analysis, interpretation and utilization of instruments aimed at measuring COAs in the context of clinical trials and/or observational studies
Ensure PROs are implemented appropriately in clinical trials, including writing relevant portions of the clinical trial protocols, training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials
Collaborate with clinical and statistical teams to ensure that COAs are appropriate analyzed and described in statistical analysis plans, study reports and publications
Prepare relevant sections of documentation and communication and questions for regulatory agency meetings, support and/or participate in meetings at regulatory agencies, and provide robust evidence in support of submission activities
Prepare abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy
Responsible for maintaining awareness of scientific, regulatory developments across GSKs oncology development programs incorporating new methodology and activities to establish communication with key outcomes research opinion leaders;
Keep up-to-date with methodologies and guidelines (including those from Regulatory Authorities) and communicate findings to VEO and functional groups as needed.
We are looking for professionals with these required skills to achieve our goals:
Master's degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology or a closely related discipline
Minimum 3 years of experience in a related role
Demonstrated experience with COA development and implementation in a pharmaceutical environment.
If you have the following characteristics, it would be a plus:
Master's degree or PhD in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology or a closely related discipline
Experience in pharmaceuticals, particularly in drug development, with demonstrated experience in clinical trial planning and execution
Experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies including a strong understanding of the FDA Patient Reported Outcomes Guidance
Experience with managing PRO development and validation projects.
Strong background in statistical methods for the evaluation of PROs/COA.endpoints.
Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data in oncology drug development.
Understanding of the evolving methods and regulatory environment with respect PRO/COA
Strong communication skills, with stakeholder engagement from operations through executive levels
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams.
Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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