Sr Manager, Epidemiology & Observational Research

Horizon Therapeutics
remote work
United States, Illinois, Deerfield
1 Horizon Way (Show on map)
July 03, 2023
At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us. The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. Position Summary Working at Horizon Therapeutics is more than a job - it's personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. Our employees are the foundation of our Company, and we look to foster their creativity and independent thought in how they approach their work. In doing so, our employees constantly find new ways to make a difference in the lives of our patients and in our community. We are a team of agile, innovative, and collaborative thinkers who are inspired and passionate about doing more for patients and enhancing the quality of their lives and their caregiver lives. We approach our work with a passion that reflects our understanding that we are part of something bigger. We strive to build meaningful careers at a Company whose values we share, because when we are given meaningful opportunities we can live up to our individual potential and therefore help patients live up to theirs. We have ambitious goals and plans for the Epidemiology and Observational Research team. The role of the Team is expanding in a way that parallels the increasing need and role of real world evidence generation and synthesis. We understand that Real World Evidence generation and observational research is integral to the successful development, submission, launch and post-marketing experience of our therapies. The Epidemiology and Observational Research team work cross functional by providing impactful real world evidence solutions to a range of internal stakeholders, such as colleagues in clinical development, pharmacovigilance and patient safety, regulatory affairs, medical affairs, etc. Additionally, our Team collaborates with external subject matter experts and partner with innovative vendors advancing real world analytics and observational studies. Therefore, we have an exciting opportunity for a permanent full time Senior Manager, Epidemiology & Observational Research based at our Lake Forest, IL office or Telecommute/Remote work. Responsibilities Conduct targeted literature reviews on disease burden of illness, clinical unmet need, natural history of disease, disease risk factors, treatment patterns, healthcare resource utilization and patient characterization. Prepare incidence and prevalence estimates of diseases/condition of interest. Review and provide critical assessments of published literature. Contribute to epidemiologic assessments for the evaluation of potential safety signals and emerging safety issues utilizing a variety of real-world data (i.e., clinical, post-marketing, pre-clinical, and other relevant real-world evidence). Also available, are in-house databases and signal detection/evaluation tools. Contribute to benefit-risk research across the life cycle of Horizon products including supporting the development of risk management plans, observational studies to assess the effectiveness of risk minimization approaches/activities, and post-marketing safety and effectiveness studies. Contribute to the conceptualization, implementation and management of global epidemiologic studies and the analyses and interpretation of study results (e.g., North America, EU, UK, Asia and emerging market countries.). Contribute to the design and conduct of fit-for-purpose real-world evidence studies and analyses, including assessing natural history or clinical burden of disease, real-world clinical practice, unmet need, healthcare resource utilization patterns, and the safety and effectiveness (comparative safety and effectiveness). Determine appropriate patient exposure calculation methodologies. Contribute to the design, conduct and analysis of post-marketing safety studies. Participate in cross-functional teams as an epidemiology/outcomes research knowledge contributor. Qualifications and Skills Required Master's degree or equivalent with significant experience in Epidemiology or other subject area with high reliance on observational research activities/methodologies. 5+ years of pharmaceutical, biotechnology, or clinical research organization (CRO) experience of which 3+ years in an epidemiology/pharmacoepidemiology, outcomes research, pharmacovigilance, or safety risk management setting. Previous experience with real world data sources (e.g., administrative claims, electronic health records, registries, safety databases). Knowledge and understanding of pharmacovigilance regulations for both investigative and marketed products. Professional demeanor and collaborative approach. Strong interpersonal skills. Excellent written and verbal communication skills Our Values Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference. Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures. Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients. These three values come to life through our five Leadership Expectations that apply to all Horizon employees Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better. Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.