Associate Director RWE Science

Overview

Job Title: Associate Director, Real World Evidence (RWE) Science Phase IV / Post-Approval (Contract)

Location: United States (Remote; Eastern Time business hours preferred)

Duration: 7-Month Contract (Full-Time, 40 hours/week)

Start: Targeting Early March 2026

We are seeking an experienced Associate Director, Real World Evidence (RWE) Science to provide coverage for a Phase IV / post-approval RWE portfolio within a global Medical Affairs environment. This is a senior-level individual contributor role requiring deep epidemiology and real-world evidence expertise, strong methodological leadership, and the ability to independently manage ongoing studies with minimal ramp-up.

This position supports global stakeholders, including Europe, and requires flexibility for early morning meetings aligned to EU collaboration.

• Lead scientific oversight of Phase IV and post-approval real-world evidence (RWE) and observational studies
• Provide methodological and technical leadership for study design, feasibility assessments, and evidence planning (EU focus)
• Oversee vendors/CROs conducting outsourced analyses; review protocols, statistical analysis plans, and outputs to ensure scientific rigor
• Conduct and/or supervise systematic literature reviews (SLRs) and meta-analyses
• Contribute to development of RWE plans aligned with regulatory, HTA, and post-approval commitments
• Support retrospective analyses leveraging real-world data sources (claims, EHR, registries)
• Guide protocol development for observational studies and pragmatic trials
• Perform evidence reviews to inform regulatory submissions, reimbursement strategy, and medical strategy
• Collaborate with Regional Medical Affairs on scientific exchange and external RWE engagement
• Support development of abstracts, posters, manuscripts, and internal scientific communications

• Advanced degree (MD, PhD, or MS) in Epidemiology, Biostatistics, Public Health, or related field
• 8–10+ years of progressive experience in epidemiology and real-world evidence
• Minimum 5 years of Pharma or Biotech industry experience
• Strong expertise in:
  • Phase IV / post-approval epidemiologic study design
  • Retrospective real-world data (RWD) analyses
  • Observational research methodologies
• Experience overseeing vendors/CROs and critically evaluating statistical methodologies
• Proficiency with statistical software (R, SAS, Stata) and strong understanding of claims/EHR data structures
• Demonstrated ability to work autonomously in a global, matrixed environment
• Flexibility to support EU collaboration across time zones

• Experience supporting regulatory or HTA-facing RWE deliverables
• Vaccines, infectious disease, or public health epidemiology background
• Experience with systematic literature reviews and meta-analyses
• R programming skills, including simulations, power calculations, or Shiny applications
• Experience with data extraction, cleaning, and standardization for RWD
• Prior authorship of scientific publications and presentations
• Experience supporting EU feasibility assessments and RWE expectations

• Senior-level RWE leadership without people management responsibilities
• High-visibility Phase IV and real-world effectiveness portfolio
• Global collaboration with strong EU engagement
• Remote flexibility within the United States

Qualified candidates with deep RWE and epidemiology expertise, strong methodological grounding, and Phase IV experience in Pharma/Biotech are encouraged to apply.