Manager, CORE

CSL•Summit, NJ

About The Position

The Manager, CORE manages and provides technical expertise for Phase IV real-world evidence research across the influenza vaccine portfolio. The role develops, coordinates, and executes 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, making scientific, methodological, and operational recommendations and contributing to evidence-generation strategy, regulatory and medical responses, and internal decision-making. The role develops and reviews study concepts, protocols, statistical analysis plans, reports, and evidence summaries. It oversees vendors, contract research organizations, database partners, academic collaborators, and investigators, managing deliverables, timelines, budgets, and risks. It also conducts literature reviews and meta-analyses, reviews and may conduct statistical analyses of real-world and meta-analytic data, and coordinates scientific dissemination through abstracts, presentations, manuscripts, and other materials. The Manager maintains knowledge of relevant literature, real-world evidence trends, epidemiologic methods, reporting standards, and emerging approaches; identifies opportunities to improve research; and collaborates with CORE, Medical Affairs, cross-functional teams, external experts, and research partners. The role ensures compliance with applicable reporting and quality standards, ClinicalTrials.gov registration requirements, Institutional Review Board requirements, regulations, and company policies. Up to 10% domestic and international travel may be required.

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 using claims databases, electronic health records, registries, published literature, and other real-world data sources, and conducting 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, including 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 research across the influenza vaccine portfolio, including studies of influenza epidemiology, vaccine effectiveness, vaccine safety, burden of disease, vaccine use, and vaccine impact.
Serve as project manager and technical project analyst for assigned internal- and external-facing studies; make scientific, methodological, and operational recommendations; contribute to evidence-generation strategy, regulatory and medical responses, and internal decision-making; and 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, contract research organizations, database partners, academic collaborators, and investigators; prioritize deliverables; develop contingency plans; and address scientific, operational, methodological, timeline, data, and resource risks to ensure high-quality work within timeline and budget expectations.
Conduct systematic literature reviews, targeted literature searches, qualitative evidence summaries, and meta-analyses to identify evidence gaps and support evidence-generation plans.
Review, interpret, and, where appropriate, conduct statistical analyses of real-world and meta-analytic data in accordance with approved research protocols.
Coordinate scientific dissemination through abstracts, congress presentations, manuscripts, and scientific exchange materials, including drafting and journal submission, author coordination, responses to reviewers, data interpretation, presentation development, and scientific review.
Maintain knowledge of relevant literature, real-world evidence trends, epidemiologic methods, reporting standards, leading authorities, academic institutions, government entities, and emerging methodological approaches; identify opportunities to improve research processes, methods, and evidence-generation approaches.
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 other 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.