Senior Director Epidemiology and RWE
We are seeking a Senior Director, Global Epidemiology and RWE candidate as we're representing a well establshed pharma organization working in infectious diseases. If interested in connecting please apply below.
The Senior Director, Global Epidemiology & Real‑World Evidence (RWE) defines, drives, and executes the U.S. RWE strategy across priority therapeutic areas while ensuring seamless alignment with global strategy. As the organization's senior methodological authority, this leader oversees complex external collaborations, advances data and methodological innovation, and shapes the company's external reputation with regulators, payers, and scientific societies. The role directly manages U.S. epidemiology talent and contributes to building world‑class global epidemiology and RWE capabilities.
Key Responsibilities
Strategic Leadership
- Define, evolve, and own the U.S. epidemiology and RWE strategy, ensuring it aligns with global scientific and evidence‑generation priorities.
- Translate global RWE strategy into operational U.S. execution across therapeutic areas (U.S., EU, Japan alignment).
Methodological & Scientific Authority
- Serve as the senior expert in epidemiologic methods, causal inference, database strategy, and observational research designs.
- Provide authoritative guidance on evidence strategy for regulatory submissions, payer negotiations, and cross‑functional decision‑making (e.g., trial design, labeling, post‑market commitments).
Operational Excellence & Resource Stewardship
- Direct multimillion‑dollar RWE budgets and long‑cycle investments, including external databases, real‑world data platforms, and vendor frameworks.
- Oversee complex external partnerships (vendors, academic collaborators, cross‑industry consortia) ensuring scientific rigor and operational delivery.
External Representation & Influence
- Represent the company as a senior scientific leader in regulatory interactions (FDA, EMA), payer evidence discussions, and major scientific societies (ISPOR, DIA, PhRMA).
- Elevate the company's external profile through thought leadership, methodological innovation, and scientific engagement.
People Leadership & Capability Building
- Directly lead U.S.‑based Directors/consultants; coach, mentor, and develop global epidemiology staff.
- Build scalable processes, SOPs, systems, and innovation pipelines that strengthen organizational epidemiology & RWE capabilities.
Innovation & Methodological Advancement
- Drive the organization's agenda for advanced epidemiologic methods, modern analytic approaches, and next‑generation real‑world data solutions.
- Anticipate evolving regulatory and payer standards and integrate them into long‑term evidence strategy.
Minimum Qualifications
- PhD in Epidemiology, Biostatistics, or related field; or MD/PharmD with formal advanced epidemiology training.
- ≥12 years of pharma/biotech experience leading global or U.S. RWE and epidemiology programs.
- Proven expertise in epidemiologic methods, RWE study design, database strategy, and observational research.
- Demonstrated track record of influencing regulators, payers, and external scientific bodies.
- Prior line‑management experience with demonstrated ability to develop scientific talent.
- Executive‑level communication skills with both technical and non‑technical stakeholders.
Core Competencies
- Ability to set and execute a U.S. RWE strategy tightly aligned to global goals.
- Recognized methodological authority and evidence‑based decision‑maker.
- Strong financial stewardship: budget ownership, resource allocation, and investment decisions.
- Exceptional external influence shaping regulatory, payer, and scientific community perspectives.
- Proven ability to build high‑performing teams and establish functional standards.
- Thought leadership in advanced methods and foresight into regulatory and RWE innovation trends.
Salary: $270-310,000 base salary + additional benefits
Location: New Jersey
FAQs
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