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:
- immuno-oncology: using the human immune system to treat cancer
- cell therapy: engineering human T-cells to target cancer
- cancer epigenetics: modulating the epigenome, the information that directs how DNA is read and used, to induce anti-cancer effects
- synthetic lethality: addressing two targets at the same time which together, but not alone, have substantial effects against cancer
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
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.