Clinical Outcome Assessment Scientist
Cambridge, Massachusetts, Madrid, Spain, Chilly-Mazarin, France
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The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients’ perspective (and other subjective perspectives) into clinical research through the utilisation of Clinical Outcome Assessments (COAs) and other methods.
The COA team reports into the 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 COA team has two primary focuses:
Defining the patient-centric COA strategy and guiding its implementation in our programs. This includes assessment of unmet needs, understanding of competitive environment, interaction with other functions contributing to the design of programs and Clinical Trials
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 1-3). Performance Outcomes (PerfO) are also covered by the COA team, who also provides increasing support for technology-enabled outcomes.
Consultation with regulators and key opinion leaders is common.
Example research activities for the COA 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; 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), Medical Affairs, Market Access, Statistics, and Commercial.
Main responsibilities: COA Scientist Role Description
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, psychometric validation and dissemination
Specific role activities for a COA Scientist include:
Provide expert advice on COA measurement needs to cross-functional molecule teams to ensure well designed medical 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
Conduct qualitative and quantitative research to inform development on conceptual disease-models and to support analyses of unmet clinical need and potential therapeutic preferences
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 medical 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 sections for COAs, 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
COA Scientist qualifications, experience and skills needed
Relevant advanced academic degree (e.g. doctorate or masters in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research…)
Training in COA methods
At least 5 years of HEOR experience in pharmaceutical industry, CRO or academic
At least 3 years of 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
Skills & competencies
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, HAS, G-BA, 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
Terms of Employment
Full time position (FTE)
Some travels should be expected for regulatory meetings attendance, scientific congress or internal key meetings (no more than 6 travels per year).
No people management responsibilities
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