Manager, CORE

Seqirus USA•Waltham, MA

About The Position

Manage and provide technical expertise for Phase IV real-world evidence research across the influenza vaccine portfolio. The role oversees studies addressing influenza epidemiology, vaccine effectiveness and safety, burden of disease, vaccine use, and vaccine impact. It serves as project manager and technical project analyst for assigned studies, makes scientific, methodological, and operational recommendations, contributes to evidence-generation strategy and regulatory and medical responses, and supports internal decision-making. Matters with broader portfolio, strategic, or material resource implications are escalated as appropriate. The position develops and reviews study concepts, protocols, statistical analysis plans, reports, and internal evidence summaries. It manages vendors, contract research organizations, database partners, academic collaborators, and investigators, while prioritizing deliverables and managing scientific, operational, methodological, timeline, data, and resource risks to deliver rigorous, high-quality work within expected timelines and budgets. The role conducts literature reviews and evidence summaries, supports meta-analyses, and reviews, interprets, or conducts statistical analyses of real-world and meta-analytic data under approved protocols. It coordinates dissemination through abstracts, congress presentations, manuscripts, and scientific exchange materials, including drafting, journal submission, author coordination, reviewer responses, data interpretation, presentation development, and scientific review. The position maintains knowledge of relevant research, real-world evidence trends, epidemiologic methods, reporting standards, and emerging approaches; identifies opportunities to improve research processes; participates in CORE, Medical Affairs, and cross-functional teams; and collaborates with internal and external stakeholders. It ensures compliance with applicable epidemiologic reporting and quality standards, including STROBE guidance, ClinicalTrials.gov registration requirements, Institutional Review Board requirements, applicable regulations, and company policies and procedures.

Requirements

Graduate degree (Master’s or PhD) in public health, epidemiology, biostatistics, pharmacoepidemiology, health outcomes research, or a related scientific discipline; equivalent relevant experience may be considered.
At least three years of experience in observational research, real-world evidence generation, epidemiology, health outcomes research, or statistical programming using clinical, claims, registry, or electronic health record data.
Strong understanding of Phase IV outcomes research, observational study design, real-world evidence generation, and epidemiologic methods, including comparative effectiveness research, causal inference, confounding control, and vaccine effectiveness methods.
Experience with claims databases, electronic health records, registries, published literature, and other real-world data sources, and with systematic literature reviews and meta-analyses.
Experience programming and reviewing statistical analyses using SAS, SQL, R, Stata, or similar software.
Excellent oral and written communication skills and the ability to translate complex scientific, epidemiologic, and statistical concepts into clear reports, presentations, publications, and internal evidence summaries.
Demonstrated project-management expertise, including the ability to independently manage multiple priorities, ambiguity, timelines, budgets, and quality expectations while exercising sound judgment.
Ability to establish productive working relationships, collaborate effectively, and build consensus with colleagues, managers, cross-functional teams, vendors, collaborators, and external experts in a global, highly matrixed environment.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Ability to undertake up to 10% domestic and international travel.

Nice To Haves

R programming experience is preferred.
Experience in the biopharmaceutical industry, a contract research organization, an academic research setting, or a public health environment is preferred.
Experience in comparative effectiveness research, preferably in vaccinology, infectious diseases, influenza, or respiratory disease, is preferred.
A publication record in peer-reviewed clinical, epidemiologic, health outcomes, or methodological journals is preferred.

Responsibilities

Manage and provide technical expertise for Phase IV real-world evidence studies across the influenza vaccine portfolio, covering epidemiology, vaccine effectiveness, safety, disease burden, vaccine use, and vaccine impact.
Serve as project manager and technical project analyst for assigned studies; make scientific, methodological, and operational recommendations and contribute to evidence-generation strategy, regulatory and medical responses, and internal decision-making.
Escalate matters with broader portfolio, strategic, or material resource implications.
Develop and review study concepts, protocols, statistical analysis plans, study reports, and internal evidence summaries.
Manage vendors, CROs, database partners, academic collaborators, and investigators; prioritize deliverables, develop contingency plans, and address study risks to maintain scientific rigor, quality, timelines, and budgets.
Conduct systematic and targeted literature reviews, qualitative evidence summaries, and meta-analyses to identify evidence gaps and support evidence-generation plans.
Review and interpret real-world and meta-analytic data and, where appropriate, conduct statistical analyses in accordance with approved protocols.
Coordinate scientific dissemination through abstracts, congress presentations, manuscripts, and scientific exchange materials, including drafting, journal submission, author coordination, reviewer responses, data interpretation, presentation development, and scientific review.
Maintain knowledge of relevant literature, real-world evidence trends, epidemiologic methods, reporting standards, authorities, institutions, government entities, and emerging methodological approaches; identify opportunities to improve research and evidence-generation processes.
Participate in CORE, Medical Affairs, and cross-functional project teams and collaborate with internal stakeholders, external experts, professional associations, vendors, and research partners.
Ensure studies and company activities comply with applicable epidemiologic reporting and quality standards, including STROBE guidance, ClinicalTrials.gov registration requirements, Institutional Review Board requirements, applicable regulations, and company policies and procedures.