Director/Senior Director, Clinical Outcomes Assessment (COA) Strategy, Development & Implementation, Rare Diseases

In this newly created role, as the Senior Director of COA Strategy, Development & Implementation, you will be responsible to ensure assets across the pipeline, including assets focused on rare disease, have incorporated COA measures that are fit for purpose and appropriate for label inclusion. The position will also focus on integration of digit health technologies into clinical protocols to further inform impact of treatment effect on patient outcomes.

• Some of your responsibilities will include:

  • Engaging with cross-functional development teams to inform COA strategy that will lead to measures that are fit for purpose and appropriate for label inclusion.
  • Conducting qualitative studies (concept elicitation | cognitive debriefing) and psychometric analyses to ensure measures are fit for purpose for a given context of use and exhibit reliability, validity and responsiveness.
  • Educating cross-functional colleagues on the technical aspects of COA strategy, development & implementation.
  • Collaborating with Biostats, Clinical Operations, Data Management and Risk Management, to ensure operational excellence in the implementation of COA measures in clinical trials including use of appropriate KPIs and reports that help ensure data integrity and that COA measures are being collected as per the Schedule of Assessments.
  • Identifying and implementing out-of-the-box studies | initiatives that help advance the use of COA measures in clinical practice to help improve patient outcomes.
  • Representing Shionogi in external-facing forums to help establish Shionogi as a thought leader in COA measurement sciences.

   

  What We Are Looking For

  We are seeking a highly experienced and strategic individual with:

  • Expertise in identifying and implementing COA-related strategies in clinical trials.
  • Deep subject matter expertise in FDA’s PRO and PFDD guidance documents.
  • Experience in developing de novo COAs preferred.
  • Experience working in rare diseases is preferred.
  • Strong communication and project management skills.
  • Ability to work with patient advocacy organizations.
  • Demonstrated ability to work and influence colleagues in a matrixed organization.
  • Willingness to travel 30% of the time.
  • Masters or PhD in health sciences, psychology, statistics, or related field is preferred.

   

  Join Us: If you are passionate about improving patient outcomes and driving innovation in clinical outcomes assessment, please apply. Together, we can make a difference in the lives of patients with rare diseases.

Other Requirements

• This position 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-$295,000. 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, vehicle allowance, bonus, long-term incentive, 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.