Patient-Centered Outcomes Research Leader -flexible location
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech
company with offices in Europe in Belgium (Mechelen), France (Romainville + Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), UK (London), Germany (München), and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
Currently, we are looking for a Patient-Centered Outcomes Research Leader !
This role is flexible and can be based in any of our above locations.
Scope of the job
This position functions within Global Medical Affairs, which contributes to the successful development and commercialization of new and innovative therapies. This person will provide leadership and expertise to develop specialized technical expertise in support of Galapagos’ exciting portfolio to support Patient Reported Outcomes (PRO) / Clinical Outcome Assessment (COA) strategies.
This is an integral role in the development of integrated evidence plans to ensure that strong COA strategies support a patient-centric understanding of medicines. Our mission is to deliver strong measurement science to capture the patient voice in demonstrating the value of our products to patients, physicians, payers and regulators. You will work in close partnerships with functions including clinical development, clinical operations, regulatory affairs, value & market access and commercial. You will develop relationships 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 line with the increasing requirements by regulatory agencies on PROs. This role will work closely with teams to ensure development programs have a well-characterized innovative COA strategy with plans to develop evidence supporting endpoints.
- Define and implement strategies for development and implementation of PRO/COAs across Galapagos' portfolio
- Develop global COA endpoint strategic plans to assure alignment with product goals
- Effectively communicate and execute COA strategies, assuring alignment with clinical, value and market access, 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
- Responsible for recommending appropriate sensory / wearable and digital technologies to support novel patient centric endpoints in studies
- 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 Galapagos' 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)
Who are you?
- Masters degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology or a closely related discipline
- Minimum 7 years of experience in a related role
- Demonstrated experience with COA development and implementation in a pharmaceutical environment.
- Experience in pharmaceuticals, particularly in drug development, with demonstrated experience in clinical trial planning and execution
- Experienced with PRO/COA requirements for regulatory approval including a strong understanding of the FDA Patient Reported Outcomes Guidance and COA procedures
- Familiarity of HTA and reimbursement agency PRO requirements
- Experience with managing PRO development and validation projects.
- Broad experience in collaborating with research partners and in managing multiple tasks and complex projects is expected.
- Demonstrated ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
- Record of high-quality, peer-reviewed real world evidence studies, outcomes research and/or epidemiology research publications is required.
- Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data in drug development.
- Understanding of the evolving methods and regulatory environment with respect PRO/COA
- Excellent analytical, planning and organizing skills
- Out-of-the-box thinking
- Coaching, collaboration and leadership skills
- Excellent stakeholder management skills
- Proven track record of consensus building and conflict management in challenging situations
- Nurtures innovation and supports the team to bring innovation to reality
- Fluent in English, both in speaking and in writing
What’s in it for you?
You will be part of a fast-growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos, we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos: together we can make it happen…!