Real World Evidence & Epidemiology Lead
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel), 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’.
Due to our exciting partnership with Gilead Sciences Inc. we are looking for a Real World Evidence (RWE) & Epidemiology Lead.
The position will be based in one of our European locations BE, NL, FR, CH.
Scope of the job
As RWE & Epi Lead you will design and execute global RWE projects using RWD to support our promising pipeline of innovative medicines. Your contributions will advance our deeper understanding of disease and the real-life.
- Development and execution of evidence generation and epidemiology strategies throughout the product life cycle (e.g. any study design evaluating the outcomes of healthcare interventions-- observational cohort studies, cross-sectional studies, systematic reviews, meta-analyses, etc.) in conjunction with key stakeholders
- Be an integral part of the franchise teams and provide strategic direction regarding evidence generation and epidemiology
- Ensures effective, highly scientific quality and timely execution of deliverables
- Ensure a robust dissemination plan for use of OR and Epi data
- Development of study designs across the product life cycle to demonstrate product value for target audiences (payers, physicians, or patients).
- Ensures effective communication and collaboration with all internal and external stakeholders
- Support the development of the product value proposition, contributes evidence to the Global Value Dossier (GVD), and actively contributing to completing the GOR evidence supporting the value proposition.
- Maintain awareness of global ORE requirements, regulatory legislation, payer and HTA trends and requirements
- Provide guidance and oversight on the development and execution of clinical outcomes assessment strategies and projects (e.g, patient reported outcomes) for inclusion in clinical and real world studies and as needed to support regulatory submissions
- Must have a broad view of the role of epidemiology and Pharmacoepidemiology in product support, contributing across target identification, through drug development, value demonstrations, market access, and post-approval effectiveness and safety.
- Work closely with Heath Economics and Market Access team to provide support for HTA submissions and requests
- Critical appraisal and synthesis of relevant epidemiological literature, including to support exploration of new disease areas
- Pharmacovigilance support, including risk management; PASS development and delivery; contributions to RMPs, PSURs, and regulatory responses as needed; understanding inherent risks associated with a given product’s indication; providing population-level context for safety; understanding and responding to potential safety issues
Who are you?
- You are a professional preferably with a Master’s/PhD degree in ORE related field (Public Health, Economics, Epidemiology, Statistics, Health Services Research (or similar). 10 or more years of experience in life science related field is preferred
- Experience in OR research methodologies (Retrospective observational cohort, cross-sectional studies, registries, etc.) and Epidemiology to support product development and reimbursement efforts
- Experience in therapeutic area of Fibrosis and Inflammation is a plus.
- Preferred: experience with comparative effectiveness research, personalized medicine, direct interaction with regulatory authorities, patient risk management program evaluation
- Ability to make complex judgments, develop innovative solutions, and apply comprehensive cross-functional and industry understanding to individual projects and programs
- Insight on when and how to access and effectively engage and consult external resources and scientific experts
- Effectively represent the Company to external stakeholders, including regulatory authorities and key scientific opinion leaders
- Thorough knowledge of epidemiological methodology and its applications to the pharmaceutical industry at an international level
- Comprehensive knowledge of drug development and life cycle management, as well as business strategy, drug commercialization, pharmacovigilance, and patient risk management
- High degree of initiative, proactivity, flexibility, and ability to work independently in a fast-paced environment
- Proven team-working, leadership, follow-through, stakeholder management, organizational awareness, and project management skills, within a complex, multi-disciplinary, team-based environment
- Ability to effectively engage with a wide variety technical and business experts
- Expert knowledge of large databases relevant to epidemiologic research
- Appropriate understanding of global market access requirements for pharmaceutical products
- Experience in outcomes research analyses of healthcare claims datasets, clinical outcomes assessment, health economic evaluations
- Ability to work cross-functionally and independently with a self-motivated mindset
- Excellent written and verbal communication skills in English as well as communication, influencing, negotiation skills and orientation to drive for results
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 biopharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos: together we can make it happen…!