The Director/Sr Director of Psychometrics within Clinical Development, will be responsible to ensure that Clinical Outcomes Assessments –rated by clinician, caregiver or participants-- included in drug development clinical trials as primary or key secondary endpoints have the necessary psychometric properties to support regulatory submissions. This position works closely with Shionogi’s Clinical Outcome Assessment Center of Excellence and other cross-functional colleagues to help inform all clinical trial endpoints based on quantitative measurement properties of an assessment within a given context of use.

• Engage with assets across the pipeline to collect evidence from public domain that a given assessment has the necessary psychometric properties to support its use within a given study population (context of use).
• Inform study protocols to ensure there is robust data generation to support psychometric analysis as needed.
• Collaborating with Study Teams --Medical Science, Biostats, Clinical Operations, Data Management-- to ensure operational excellence in the implementation of COAs in clinical trials including training and use of KPIs and reports to ensure data integrity
• Develop and oversee psychometric analysis plans to generate evidence that assessments used in clinical trials are fit for purpose in a given context of use.
• Inform meaningful change | meaningful score differences | responder thresholds in clinical trials based on psychometric analysis.
• Incorporate necessary quantitative evidence into regulatory dossiers that a given assessment has the necessary properties to support label inclusion, namely that the assessment has demonstrated reliability, validity and responsiveness.
• Representing Shionogi in external-facing forums to help establish Shionogi as a thought leader in COA measurement sciences.

• Partner with Shionogi’s Clinical Outcome Assessment Center of Excellence and other functions to ensure that the voice of the patient, as it relates to concepts that matter to patients who are seeking care for treatment of a given medical condition, is considered in the measures in a clinical trials.
• Assessment and recommendation of vendors to work with in the conduction of Psychometric Analysis Plans, as well as vendor oversight.
• Other duties as assigned.

Minimum Job Requirements

Qualifications

• Advanced degree in psychology, psychometrics, statistics, clinimetrics, or measurement sciences. Doctorate level preferred.
• 10 plus years within the pharmaceutical industry with responsibility for quantitative evidence generation & synthesis specific to demonstrating assessments are reliable, valid and responsive based on its measurement properties. Experience in interactions with FDA and other major regulatory authorities on matters of endpoint validation is highly desirable.

Competencies

• Deep subject matter expertise as it relates to measurement sciences including but not limited to Classical Test Theory, Item Response Theory (Rasch Model) and modern validity theory.
• Proven track record in conducting psychometric analyses; informing study protocols to enable data collection to support psychometric analyses; engaging with regulatory agencies to demonstrate that assessments have the necessary quantitative measurement properties for inclusion in labels.
• Strong working knowledge of FDA’s 2009 PRO Guidance Document and 2018-2023 PFDD Guidance Documents.
• Strong written and verbal communication skills.
• Ability to work cross-functionally; willingness to be a team player and engage with colleagues in a collaborative manner.
• Strong project management skills including achieving project milestones and maintaining timelines.
• Strong work ethic and a commitment to operational excellence.

Other Requirements

• This is an individual contributor role and does not have significant managerial and decision-making authority.
• Ability and willingness to travel approximately 30% 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

Additional Information

The base salary range for this full-time position is $215,000 - $285,000. 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, long-term incentive, 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.

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.