Shionogi is committed to incorporating the patient’s experience for a specific disease-state into its development programs. 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, should translate into endpoints in a clinical trial that are being measured for inclusion in the regulatory label. The Director | Senior Director of COA Strategy Development & Implementation will be responsible to ensure assets across the pipeline, including assets focused on rare diseases, have included the right COA instruments to support given patient-centered endpoints. The Food and Drug Administration (FDA) has stringent requirements for endpoints that are measured by COAs as evidenced by the 2009 FDA PRO guidance document and the more recent patient-focused drug development (PFDD) guidance documents. To inform the right COA strategies for a given asset in development, this position requires deep subject matter expertise in regard to COA instruments, the requirements for developing effective COA strategies and ensuring COA instruments are fit for purpose for label inclusion. This position requires the relevant knowledge to be able to identify publicly available instruments as well as the ability to either modify these instruments or to develop instruments de novo and to be able to work with clinical operations to ensure the COA instruments included in the clinical trials are implemented appropriately and ensuring missingness of data is reduced and that quality data is collected.

• Engage with assets across the pipeline to identify patient-relevant concepts, guide asset team’s decision on COA instruments that support clinical trials endpoints.
• Determine if COA instruments are fit for purpose for label inclusion; guide the cross-functional team to assess COAs’ label worthiness based on FDA regulatory guidance (2009 PRO guidance document; 2018-2023 PFDD guidance documents).
• Conduct landscape assessments to better understand relevant patient concepts for a given disease area.
• Conduct concept elicitation to further patient-relevant concepts specific to a given disease area.
• Determine whether to use publicly available COA instruments as is, modify or develop de novo based on COA strategies that will inform necessary claims and support market differentiation to help improve patient outcomes.
• Conduct as needed cognitive interviews and/or exit interviews to further enhance patient experience data.
• Engage with regulatory colleagues to complete briefing books to gain FDA guidance on instrument development and/or inclusion in clinical trials to ensure instruments supporting endpoints will be acceptable for label inclusion.
• Develop and oversee psychometric analysis plans to generate evidence that instruments 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 COAs.
• Participate in relevant conferences and congresses to help establish Shionogi as a COA innovator.
• Support Shionogi’s COA Center of Expertise (COE) as it relates to development of newsletters and webinars to deepen and strengthen organizational knowledge specific to COAs and developing market trends.
• Work with colleagues in policy to help inform strategies to further advance the use of patient experience data in clinical development programs.

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.
• Ability to work with patient advocacy organizations representing patients with rare diseases.
• Strong working knowledge of COA-related terms.
• 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.
• 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.

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.