Associate Director Real World Evidence Scientist

Millipore Corporation; Billerica (MA); Hybrid; USD 131,000 - 211,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perquisites

Job summary

EMD Serono seeks a senior leader to oversee Real World Evidence studies, guiding end-to-end non-interventional research and influencing regulatory and strategic plans. You will interface with Global Program Teams and key stakeholders to develop data strategies and strengthen external collaborations.

The role requires advanced epidemiology training, 5+ years in pharma/biotech, and proven experience with real-world data sources, data standards (OMOP/FHIR), and regulatory interactions.

Qualifications

• Doctoral and/or master's degree in Epidemiology, Public Health or related field.
• 5+ years experience in health and life sciences or quantitative data sciences.
• 5+ years of experience in pharmaceutical/biotechnology industry, CRO, or academic setting.
• Experience with secondary data studies across Europe, US, Asia.
• Experience with global regulatory and/or payer submissions and interactions.
• Familiarity with ISPE GPP, GVP, ENCePP.

Responsibilities

• Lead non-interventional studies end to end.
• Provide methodological expertise in strategic forums.
• Interface with Global Program Teams and sub-teams.
• Lead selection of real-world data sources and data strategy.
• Collaborate with regulatory, medical, commercial, and health-economics teams.
• Support interactions with health authorities and respond to regulatory requests.

Skills

Epidemiology knowledge

Regulatory submissions

Biostatistics

Data sources (claims/EMR/registries)

Global collaboration

Education

Doctoral or Master’s in Epidemiology/Public Health

Tools

OMOP CDM

FHIR

CPRD/Optum/IQVIA/TriNetX

Job description

Work Your Magic with us! Start your next chapter and join EMD Serono.Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology, Immunology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Location:

The Associate Director, Real World Evidence, is a hybrid role based in Billerica, MA and minimal domestic and international travel will be required to meet business needs.

Your Role

The Associate Director, Real World Evidence, is an experienced functional lead and subject matter expert who proactively contributes to the development and implementation of the Real-World Evidence and Real-World Data (RWE/RWD) strategy for a therapeutic area or set of compounds, with a primary focus on supporting regulatory objectives. Operating with a high degree of independence, this role leads non-interventional studies end to end, provides methodological expertise in key internal strategic forums, and interfaces with Global Program Teams and their sub-teams.

Responsibilities

• Serve as the functional product lead and subject matter expert for assigned studies, conducting needs assessments with relevant stakeholders.
• Provide senior-level strategic input into drug development plans and Product Integrated Evidence Plans.
• Execute the RWE strategy for assigned products and lead studies with minimal supervision.
• Represent and defend projects at internal boards, governance committees, and senior management meetings.
• Lead the identification and selection of appropriate real-world data sources, and drive the development of the therapeutic area's real-world data strategy.
• Collaborate closely with development, regulatory, medical, commercial, market access, and Patient Real-World Evidence (PRWE) teams.
• Lead Non-Interventional Studies from end to end, including study design, planning, protocol development, monitoring, analysis, study reporting, and dissemination of results.
• Support interactions with health authorities and develop responses to requests from regulatory agencies.
• Foster cross-functional collaboration and maintain and expand external collaborations with other quantitative scientists.

Minimum Qualifications

• Doctoral and/or master's degree (e.g., PhD, MSc) in Epidemiology, Public Health or related field.
• 5+ years experience in health and life sciences (MD, pharmacist epidemiology, public health), or quantitative data sciences, biostatistics.
• 5+ years of experience in pharmaceutical/biotechnology industry, CRO, or academic setting.
• Demonstrated experience in studies based on secondary data use (claims, EMR, registries) across different types and healthcare environments (Europe, US, Asia).
• Comprehensive expertise in drug development, including interfaces and interdependencies of clinical development with other functions.
• Experience in global regulatory and/or payer submissions and interactions.
• Experience with the regulatory environment and standards (ISPE GPP, GVP, ENCePP).

Preferred Qualifications

• Experience in studies based on primary data collection.
• Experience in at least one key therapeutic area (Oncology, Neurology, Immunology).
• Knowledge of federated data networks (CPRD, Optum, IQVIA, TriNetX) and OMOP CDM or FHIR data standards.
• Experience with AI/ML applications in RWE, including NLP.
• Track record of thought leadership (publications, conference presentations).
• Experience in budget management and vendor oversight.
• Knowledge of health equity and DEI principles in evidence generation.
• Experience with patient-reported outcomes (PROs) and HTA.
• Excellent oral and written communication skills and demonstrated ability to engage and communicate scientific evidence to peers and at scientific meetings.
• Collaborative, proactive working style, with ability to work independently.

Pay range for this position: $131,000 - $210,600

• Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.
• Position may be eligible for sales or performance-based bonuses.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology.

We are committed to creating access and opportunities for all to develop and grow at your own pace.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!