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

Shionogi Inc.•Florham Park, NJ

23h•$215,000 - $295,000•Hybrid

About The Position

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 cross‑functional 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.

Requirements

Masters or PhD in health sciences, psychology, statistics or another related field.
Requires a minimum of 7 years (Director) or 10+ years (Senior Director) of experience within pharmaceutical industry with responsibility for developing and implementing COA-related strategies and tactics.
Deep subject matter expertise in COA measurement sciences.
Strong working knowledge of FDA’s 2018-2023 PFDD Guidance Documents including market trends.
Understanding of quality reporting to ensure data collection is consistent within and across measures; 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.
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

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.