Senior Director, Epidemiology & Real World Evidence

Shionogi•Florham Park, NJ

9d•$270,000 - $305,000•Hybrid

About The Position

Overview The Senior Director, Global Epidemiology & Real-World Evidence (RWE) sets and drives the U.S. RWE strategy across therapeutic areas while ensuring alignment with global vision. Serving as a methodological authority, the Senior Director directs large, complex vendor relationships and database investments, integrates RWE across functions, and represents the company externally with regulators, payers, and scientific societies. The role provides leadership to global epidemiology staff and plays a critical role in shaping organizational-level RWE standards, innovation, and external influence. Responsibilities Define and own epidemiology and RWE strategy across therapeutic areas, with a strong focus on the U.S. Serve as authority on epidemiologic methodologies, causal inference, database strategy, and vendor frameworks. Cascade global RWE vision into U.S. execution; ensure alignment across geographies (U.S., EU, Japan). Direct large, complex RWE budgets, including database investments, vendor partnerships, and external collaborations. Provide authoritative input into organizational decisions (trial design, labeling, regulatory/payer evidence packages). Represent company externally as a thought leader at FDA/EMA meetings, payer negotiations, and scientific societies (ISPOR, DIA, PhRMA). Lead organizational-wide innovation in epidemiology, advancing methodologies and data capabilities. Directly manage U.S.-based Director and consultants; provide mentorship across global epidemiology functions. Build functional capabilities, including processes, SOPs, systems, and innovation pipelines. Other duties as assigned.

Requirements

PhD in Epidemiology, Biostatistics or related field; or MD/PharmD with advanced epidemiology training.
Minimum 12 years in pharma/biotech with demonstrated leadership of global RWE programs.
Proven expertise in epidemiologic methods, database strategy, and observational research designs.
Strong record of regulatory engagement, payer influence, and external thought leadership.
Prior line management experience with ability to mentor and develop scientific staff.
Executive presence with excellent communication skills across technical and non-technical audiences.
Ability to set U.S./organizational-wide RWE strategy aligned to global vision.
Recognized methodological expert and decision-maker.
Owns and directs budgets; allocates resources effectively.
Demonstrated ability to influence regulators, payers, and scientific societies.
Builds teams, sets functional standards, and develops global RWE capabilities.
Champions advanced methods and anticipates regulatory trends.
This role has significant authority and decision-making rights at the U.S. organizational level (TA-spanning, global alignment, methodological authority, budget ownership, external representation).
Ability and willingness to travel approximately 10-15% of the year both domestically and internationally
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
Office presence required at least 50% of the time per month

Responsibilities

Define and own epidemiology and RWE strategy across therapeutic areas, with a strong focus on the U.S.
Serve as authority on epidemiologic methodologies, causal inference, database strategy, and vendor frameworks.
Cascade global RWE vision into U.S. execution; ensure alignment across geographies (U.S., EU, Japan).
Direct large, complex RWE budgets, including database investments, vendor partnerships, and external collaborations.
Provide authoritative input into organizational decisions (trial design, labeling, regulatory/payer evidence packages).
Represent company externally as a thought leader at FDA/EMA meetings, payer negotiations, and scientific societies (ISPOR, DIA, PhRMA).
Lead organizational-wide innovation in epidemiology, advancing methodologies and data capabilities.
Directly manage U.S.-based Director and consultants; provide mentorship across global epidemiology functions.
Build functional capabilities, including processes, SOPs, systems, and innovation pipelines.
Other duties as assigned.