Description

Shionogi is committed to incorporating the voice of the patient into its clinical development programs. The Director/Senior Director of COA Strategy, Development & Implementation is responsible for developing a given asset’s COA strategy to ensure patient centered, regulatory acceptable, and value laden endpoints are incorporated into the development program. This role provides strategic leadership to cross-functional study teams to ensure COA measures are fit-for-purpose to inform patient-physician treatment strategies, health technology assessments, and payers’ willingness to pay. The successful candidate will have deep subject matter expertise in COA measurement sciences, excellent communication skills, and demonstrated experience in effectively collaborating with crossfunctional colleagues and external suppliers to ensure adoption of strategic recommendations, development of de novo measures as needed, and enabling operational excellence to ensure high quality data collection. The position sits within Global Scientific Operations, alongside Healthcare Value and Access, Epidemiology & Real-world Evidence, and Medical Affairs.

Responsibilities

• Engage with assets across the pipeline to identify patient-relevant concepts, guide asset team’s decision on COA measures that support clinical trials endpoints.
• Determine if COA measures are fit-for-purpose for label inclusion; guide the cross-functional team to assess COAs’ label worthiness based on FDA regulatory guidance (2018-2023 PFDD guidance documents).
• Conduct landscape assessments to better understand relevant patient concepts of interest and meaningful aspects of health for a given disease area.
• Conduct concept elicitation to identify and/or confirm patient-relevant concepts of interest and meaningful aspects of health specific to a given disease area.
• Determine whether to use publicly available COA measures as is, modify or develop de novo measures based on COA strategies that will inform necessary claims, support market differentiation, and access-related decision-making to improve patient and health system outcomes.
• Conduct cognitive interviews if developing de novo measures.
• Collect patient experience data including conduct embedded clinical trial interviews.
• Engage with regulatory colleagues to complete briefing books to gain FDA guidance on measure development and/or inclusion in clinical trials to ensure measures supporting endpoints will be acceptable for label inclusion.
• Develop and oversee psychometric analysis plans to generate evidence that COA measures used in clinical trials are fit for purpose in the specific context of use.
• Work with clinical operations to ensure data missingness is reduced; that eCOA suppliers have the necessary skill set to effectively implement the COAs that have been included in the protocol and appropriate data reporting is undertaken on a regular basis to ensure quality data is being collected.
• Enable out-of-the-box thinking to enable Shionogi to be an innovator in the area of COA measurement science.
• Participate in relevant conferences and congresses to help establish Shionogi as a COA measurement science innovator.
• Contribute to Shionogi’s COA Center of Expertise (COE) to help deepen and strengthen cross-functional colleagues’ knowledge of COA measurement sciences and developing market trends.
• Work with colleagues in policy to help inform strategies to further advance the use of patient experience data to help inform access-related decision-making and patient care in clinical practice.

Requirements

Minimum Job Requirements

Qualifications

• Masters or PhD in health sciences, psychology, statistics or other related field.
  12 plus years within pharmaceutical industry with responsibility for developing and implementing COA-related strategies   and tactics

Competencies

•  Deep subject matter expertise as it relates to FDA’s 2009 PRO Guidance Document and 2018-2023 PFDD Guidance             Documents.
• Understanding of quality reporting to ensure data collection is consistent within and across instruments; that outliers     are appropriately identified, and sites are trained to improve quality data collection.
• Strong communication skills including written and verbal.
• Ability to engage with colleagues in commercial, medical, clinical, development, regulatory, market access and other     relevant functions to gain alignment on COA-related strategic and tactical plans.
• Ability to think out-of-the-box to identify and implement strategic frameworks to utilize multimodal measurement strategies to assess treatment effect including biomarkers and wearable devices.
• 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 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

 Essential Physical and Mental Requirements

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a   time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.
• To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

Disclaimer

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

EEO Statement

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, 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 in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.