Viatris Pharmaceuticals S.L. is hiring a Director, Outcomes Research to lead global outcomes research strategies and evidence generation. You will drive the evidence needed to support the company's innovation portfolio, designing and executing studies that integrate clinical, humanistic, and economic endpoints to meet medical affairs, market access, regulatory, and commercial objectives.
What You'll Do
- Lead and execute global, cross-functional evidence generation plans to support medical affairs, clinical development, market access, health economics, regulatory affairs, and commercial needs for the innovation portfolio.
- Design and execute retrospective and prospective observational studies, including burden-of-illness, natural history, and incidence/prevalence assessments.
- Lead the design and execution of comparative studies, including Comparative Effectiveness Research (CER), Indirect Treatment Comparisons (ITC), and External Control Arms (ECA).
- Lead the strategy and execution of select literature reviews and meta-analyses to inform internal decisions and support HTA dossier submissions.
- Lead the integration of patient voice through quality-of-life instruments into clinical trials and oversee the design of patient surveys for regulatory and HTA submissions.
- Develop Outcomes Research strategies to ensure incorporation of clinical, humanistic, and economic endpoints into clinical trial designs and development plans.
- Collaborate with cross-functional teams to ensure alignment of Outcomes Research initiatives with the company's strategic goals.
- Build and maintain relationships with key stakeholders in academic, healthcare, and payer domains.
- Engage with industry associations, policymakers, and thought leaders to advocate for the importance of real-world evidence.
- Communicate complex scientific findings clearly and effectively to senior leadership, including C-suite and VP-level executives.
- Communicate Outcomes Research strategies and findings through peer-reviewed publications, scientific congresses, and advisory meetings.
- Develop and review observational research protocols, statistical analysis plans (SAPs), and reports.
- Closely work with a team of Outcomes Research scientists and researchers, ensuring high standards of research quality, efficiency, and productivity.
- Ensure adherence to regulatory requirements and ethical standards for Outcomes Research studies, including data privacy and patient consent.
- Monitor budget and resource allocation for Outcomes Research initiatives.
- Manage the selection and use of real-world data sources to support evidence generation.
- Develop and apply cutting-edge methodologies in statistical analysis, epidemiology, and health economics.
- Ensure data quality and integrity through appropriate validation, cleaning, and analysis of real-world data.
What We're Looking For
- A Master’s degree is required.
- 5 years of biopharmaceutical industry experience in evidence generation and Outcomes Research methodologies.
- Research expertise in Outcomes Research, such as observational studies, patient-reported outcomes, clinical-economic modeling, or meta-analysis.
- Experience managing large and global datasets, conducting complex data analyses, and extracting meaningful insights.
- Demonstrated ability to develop and execute strategic plans aligned with business objectives.
- Excellent written and verbal communication skills, with the ability to present complex information to diverse audiences.
- Proven ability to collaborate effectively with cross-functional teams, including medical affairs, clinical development, commercial, and regulatory.
- A strong understanding of the pharmaceutical industry, including drug development, registration, commercialization, and market access.
- Technical expertise including study protocol development, methods/algorithms, statistical and data analysis plans, and insights for publications.
- A record of high-quality, peer-reviewed real-world evidence studies, Outcomes Research, and/or epidemiology research publications.
- Proficiency in speaking, comprehending, reading, and writing English is required.
Nice to Have
- An advanced degree (PhD, MD) in epidemiology, public health, biostatistics, or a related field is strongly preferred.
Team & Environment
You will closely work with a team of Outcomes Research scientists and researchers, ensuring high standards of research quality, efficiency, and productivity.
Benefits & Compensation
- Competitive salaries, benefits, and an inclusive environment.
- Compensation range: $112,000 - $236,000 USD.
Work Mode
This role operates on a global scale.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
