Executive Director, Global Real-World Evidence

The Executive Director, Global Real-World Evidence is part of the Clinical Development group and provides strategic oversight and direction for pre-launch RWE generation with a focus on supporting clinical trial designs and observational studies to generate innovative and new treatment approaches on a global and/or regional scale for assets in clinical development.

The candidate will be a thought leader with the technical skills to build innovative and scientifically credible evidence for product development and regulatory approval. The successful applicant will lead the evaluation of observational research methods and statistical analysis to define appropriate research data sources, study design, and analytical approaches to be used for regulatory submissions, publications, clinical development plans and study designs as examples.

• Leads the development and execution of pre-approval RWE operating plans. 
• Collaborates with multiple stakeholders and partners throughout the organization to design Real-World Evidence (RWE) studies for pre-approval stage assets.
• Implements analyses to address product- and disease-area research questions, which will inform business decisions about the research and development of products.
• Collaborates with Medical Affairs to provide patient-centric outcomes and healthcare impact by providing RWE insights into medical decision making
• Drive the preparation and submission of regulatory documents related to RWE
• Collaborate with cross-functional teams, including R&D, clinical development and commercial functions, to ensure alignment and compliance with product development milestones.
• Develop data requirements to meet the RWE objectives
• Represent the company's interests in industry forums, working groups, and regulatory meetings, advocating for regulatory policies and positions that support product development and commercialization objectives.
• Serve as a subject matter expert on global RWE requirements, guidelines, and best practices.
• Prepare and present updates, progress reports, and strategic recommendations to senior and/or executive leadership informing decision-making and driving RWE excellence within the organization.
• Other duties as assigned.

Minimum Job Requirements

Qualifications

• Master’s degree in Public Health, Health Services Research, Economics, Epidemiology, Pharmacy, Health Policy, or a related discipline required. (MD, PhD, PharmD) preferred.
• 10+ years of relevant work experience with a focus on evidence generation, specifically a focus on real-world evidence methodologies / approaches (strongly preferred).
• Proven track record of successful leadership, with demonstrated ability to influence work and align with multiple internal and external stakeholders.
• Strong knowledge of HCP and Payer evidence needs and what is required to support these needs.
• Previous leadership responsibility with demonstrated ability to think and act strategically and proven tactical experience and delivery of results.
• Strategic mindset with the ability to anticipate challenges, identify opportunities, and develop innovative solutions to achieve regulatory objectives.

Competencies

• Strong leadership skills with the ability to effectively lead and motivate a multidisciplinary team, foster collaboration, and drive results in a fast-paced and dynamic environment.
• Ability to conduct and oversee clinical data analysis, epidemiology, and biostatistical elements of RWE and epidemiology.
• Proficiency in preparing and submitting regulatory documents, study plans and publications.
• Strong interpersonal and communication skills with the ability to effectively engage and collaborate with internal stakeholders, cross-functional teams, and external regulatory authorities to achieve regulatory objectives.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and regions.
• Extensive knowledge of patterns of medical practice, healthcare delivery and the current and evolving landscape within the US and globally
• To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

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.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.