Senior Director / Director Evidence Generation Lead
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Paris), the Netherlands (Leiden), Italy (Milan), Spain (Madrid) and in the 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 Senior Director / Director, Evidence Generation Lead!
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 and execute global evidence generation strategies and studies in the inflammation area. These strategies will be comprised of studies that identify clinical, economic, and patient-centered unmet needs, as well as clinical, economic, and patient-centered value that Galapagos’ medicines provide in addressing those needs.
- To provide real world evidence (RWE), outcomes research (OR) & epidemiology (Epi) support for Galapagos’ products from development through launch and commercialization across the product lifecycle.
- To collaborate and align internally with other internal and external teams within a multi-disciplinary framework to meet product needs.
- To lead the development and execution of strategies and plans to elucidate unmet clinical, economic and patient-centered needs and product value.
- To lead the periodic revision and updating of evidence generation strategies and plans in light of newly available knowledge.
- To communicate evidence generation strategies and resulting study findings to relevant internal and external audiences as effectively as possible.
- Work within a multidisciplinary, matrixed organization to lead development and creation of successful evidence generation strategies.
- Design, implement and communicate results of RWE, OR and Epi studies that help achieve product-specific objectives.
- Participate in cross-functional teams related to product development and commercialization.
- Collaborate and partner with key internal/external stakeholder colleagues and external key opinion leaders to ensure priorities and strategies are aligned.
- Oversee, as appropriate, relevant research activities which may include, but not be limited to:
- Real world evidence generation including, longitudinal prospective observational studies on product effectiveness;
- Longitudinal retrospective studies of existing databases to assess patient characteristics, treatment patterns, and associated clinical, economic and/or patient-reported outcomes;
- Retrospective or prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence;
- Cross-sectional surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities;
- Assessments exploring burden of illness and/or comparative effectiveness.
- Targeted or comprehensive systematic literature reviews;
- Development and validation of PRO and HRQoL instruments.
- Develop and/or review of observational research, outcomes research protocols, statistical analysis plans (SAPs), and reports.
- Develop and/or review, and publish scientific reports reflecting ongoing or completed work.
- Align with global internal stakeholders to meet needs of countries
- Communicate with external audiences, which may include regulators, health care providers/practitioners, HTA authorities/payers, patients and others.
- Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, dossiers and other means.
Who are you?
Education & experience:
- Experience in related real world evidence and observational studies is required (Senior Director 8-10 years; Director 5-7 years, respectively).
- Experience in outcomes research in inflammation, especially in, RA, UC & CD, is highly preferred.
- Combination of academic training and practical experience in observational & outcomes research and epidemiology is required. This may consist of:
- Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.) in a relevant discipline such as, but not limited to, health services research, health outcomes, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences;
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above).
- Expert knowledge and experience in management of epidemiology and outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is expected.
- Knowledge of health economics is highly desirable.
- Demonstrated experience in conducting or interpreting statistical analysis is required.
- Experience in leading outcomes and epidemiology research in different geographic regions is highly desirable.
- 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.
- 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
- Strong written and verbal communication skills
- 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…!