Senior Director, Epidemiology & Real World Evidence Contractor

The Consultant role for Senior Director, Global Epidemiology, will set and drive the U.S. RWE strategy across therapeutic areas while ensuring alignment with global vision. Serving as the methodological authority, the consultant 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 the U.S. and SBV epidemiology staff and plays a critical role in shaping organizational-level RWE standards, innovation, and external influence.

Define and lead U.S. epidemiology and RWE strategy across therapeutic areas.

• Serve as the 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).
• Support and/or lead to 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.

ESTABLISH DELIVERABLES & PERFORMANCE EXPECTATIONS

• Strategic leadership: Deliver U.S. epidemiology and RWE strategy and execution roadmaps for high priority assets. KPI: strategies delivered on time and endorsed by leadership.
• Methodological authority: Provide guidance on methods, causal inference, database strategy, and vendor frameworks. KPI: guidance delivered on time and applied to agreed priority work.
• Global-to-U.S. execution: Translate global RWE priorities into a U.S. plans and align U.S., EU, and Japan stakeholders. KPI: plans delivered and key alignment actions documented.
• Budget and partnerships: Advise on budgets, database investments, and vendor partnerships during assignments. KPI: recommendations delivered for agreed priority decisions.
• Enterprise decision support: Provide RWE input to priority trial, and regulatory or payer decisions. KPI: input delivered within agreed timelines and documented for key decisions.
• External thought leadership: Support selected external regulatory, payer, and scientific engagements. KPI: agreed materials and contributions delivered on time.
• Innovation and capability: Identify and prioritize opportunities to strengthen methods, data, and innovation. KPI: 1–2 recommendations delivered, with at least 1 accepted for follow-up.
• Leadership and mentoring: Provide coaching and support to assigned team members and stakeholders. KPI: agreed check-ins completed and feedback reflects effective support.
• Functional infrastructure: Assess and improve selected processes, SOPs, governance, or systems. KPI: recommendations and draft materials delivered for agreed workstreams.
• Overall performance: Demonstrate sound judgment, collaboration, and reliable delivery throughout the assignment. KPI: milestones delivered on time with no significant quality concerns.

MINIMUM QUALIFICATIONS TO THE JOB ASSIGNMENT SCOPE

• Education: PhD in Epidemiology, Biostatistics, Health Services Research, or related field; or MD/PharmD with advanced epidemiology training.
• Experience: Minimum 12 years in pharma/biotech with demonstrated leadership of global RWE programs.
• Competencies & capabilities: 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.

TRAVEL REQUIREMENTS (if applicable)

• Purpose of travel (e.g., conferences, client meetings, site visits): Travel as needed for global and regional leadership meetings, cross-functional planning sessions, regulatory or payer meetings, scientific conferences, and key stakeholder engagements.
• Percentage or frequency of travel: This will be dependent on business priorities, major meetings, and conference schedules but is expected to be no more than 20%
• Duration of travel: Typically, 1–3 days for domestic travel and 3–5 days for international travel, depending on meeting location and purpose.
• Will travel be domestic and/or international: Both domestic and international, including travel within the U.S. and to key global locations such as Europe and Japan.

Additional Information

The hourly rate for this position is $151 - $198 Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, applicable allowances, or any additional compensation that may be associated with this role. 

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

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