R&D Clinical Outcome Assessment Scientist

About the job

The remit of the Patient Insights, Outcomes and Innovations team at Sanofi is to incorporate the patients’ perspective (and other subjective perspectives, including clinicians and caregivers) into clinical research through the utilization of Clinical Outcome Assessments (COAs) and other methods.

The PCIOI team reports into the Office of Patient Informed Development and Health Value Translation (PID&HVT). Within this function the team supports all business units in deriving a patient-centric understanding of conditions and measuring relevant concepts of the condition and its treatment in a scientifically robust manner using COA instruments. The PCIOI team has two primary focuses:

• Developing, assessing, using, interpreting and disseminating COAs, including Patient-Reported Outcomes (PROs), Observer-Reported Outcomes (ObsROs) and Clinician-Reported Outcomes (ClinROs) to derive treatment benefit during the clinical development and commercialization of new molecules (Phase 1-4). Performance Outcomes (PerfO) are also covered by the COA team, whom also provides increasing support for technology-enabled outcomes.

• Supporting the development of COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies.

• Consultation with regulators, payers and key opinion leaders is common.

• Example research activities for the PCIOI team may include development of a conceptual model of disease through literature reviews, expert clinician interviews and concept elicitation interviews with patients; the systematic selection of COA instruments to measure specific concepts of interest; psychometric assessment of the measurement properties of a COA instrument (reliability, validity, responsiveness etc); development of new COA instruments, including cognitive interviews to ensure content validity; development of briefing books or dossiers for regulatory consideration of COAs for inclusion in product labelling; analysis of textual data from COAs or social media; development of routine clinical practice tools for self-management, shared-decision making and communication; and faithful migration of COA instruments from paper for electronic use.

• Internal customers include Research and Development (R&D), Health Economics and Value Assessment (HEVA; previously HEOR), Medical Affairs, Market Access, Statistics, and Commercial.
  

Major Responsibilities

• The COA Scientist is expected to be able to:

• Generate a comprehensive understanding of a disease and treatment paradigm through primary and secondary research

• Collect and evaluate drivers of patients’ disease- and treatment-related behaviour

• Examine patient insights on current treatment & perspectives on target product profiles

• Advise on the use and/or development of COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, validation and dissemination

• Specific role activities for a COA Scientist include:

• COA development and use

• Conduct qualitative and quantitative research to inform development on conceptual disease-models and to support analyses of unmet clinical need and potential therapeutic preferences

• Provide expert advice on COA measurement needs to cross-functional molecule teams to ensure well designed evidence generation plans are developed and implemented. Ensure these reflect the need for COAs from multiple stakeholders, including (where relevant), regulators, payers, healthcare professionals and patients

• Develop COA endpoints as appropriate for the clinical development programs. Includes managing research required to support the selection, development and validation of COA measures, including qualitative and quantitative research.

• Advocate for the role of quantitative and qualitative COA across Sanofi

• Manage vendors as needed

• Ensure proper input into evidence generation plans, and effective implementation related to COAs throughout execution, including writing relevant portions of the clinical trial protocols, training investigative site personnel on COA principles and appropriate administration of COAs in the studies. Develop statistical analysis plans for COAs, and with statistics, analyze and interpret the COA results from the clinical trial.

• COA summary and dissemination

• Prepare relevant sections of documentation and communication and questions for regulatory and payer agency meetings, support and/or participate in said meetings, and provide robust evidence in support of submission activities.

• Prepare abstracts and manuscripts presenting COA results from clinical and COA development and validation studies, aligned with publication strategy

• Identify, track and participate in global external collaborations regarding policy, standards and use of COAs e.g. Critical Path PRO Consortium, ISPOR and DIA Working Groups, IMI.

• Participate in creating and delivering education on COAs for internal business partners

About You:

• Experience: Experience of HEOR/CMO pharmaceutical industry, CRO or academic experience, relevant experience in COA. Proven track record in some COA disciplines incl. data analyses, scientific publication & input to clinical trials.Experience of drug development lifecycle research (including real-world evidence (RWE) research)

• Technical & Soft Skills: Native or native-like English fluency (written and spoken)

• Willing and able to travel globally

• Understanding of regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, other local agencies) environment, including joint regulatory/HTA review process

• Knowledge of the drug development process

• Strong analytical and synthesis skills of qualitative and quantitative data

• Excellent understanding of research principles and recent developments in COA

• Scientific rigor, autonomy and sense of initiative

• Good interpersonal and communication skills, both written and oral; ability to understand and communicate with representatives from the range of disciplines

• Ability to manage multiple priorities and projects, and balance workload and timelines; Able to work in a fast-paced and dynamic environment

• Ability to work effectively either in small teams or independently Ability to interact and manage external and internal networks

• Senior level personnel are additionally responsible for: coordinating the function at the portfolio level to ensure optimal integration of external advisory forums. Establishing broader COA strategy and team updates, as needed to LT. Identify new opportunities to integrate PRO/COA strategy further ‘upstream’ in clinical development life cycle (ie Ph I). Mentoring of entry level personnel.

• Education: Relevant advanced academic degree (e.g. doctorate or master's in health economics, clinical psychology, public health, epidemiology, psychometrics).Training in COA methods