Clinical Outcome Assessment (COA) Scientist
Bridgewater, New Jersey, Cambridge, Massachusetts, Lyon, France, Chilly-Mazarin, France
The remit of the Clinical Outcome Generation (COG) team at Sanofi is to incorporate the patients’ perspective (and other subjective perspectives) into clinical research through the utilization of Clinical Outcome Assessments (COAs) and other methods.
The COG team reports into the Office of the Chief Medical Officer (CMO). 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 COG 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 2-4). 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.
Internal customers include Research and Development (R&D), Health Economics and Value Assessment (HEVA; previously HEOR), Medical Affairs, Market Access, Statistics, and Commercial.
The COG team contains 2 profiles which differ in terms of fields of expertise and focus:
- Clinical Outcome Assessment (COA) Scientist – Works across the lifecycle of drug development (Phases 2-4) to generate patient insights about disease and treatment and develop COA measurement strategies to support development, post-authorization and commercial research activities
- Clinical Outcome Assessment (COA) Expert Co-ordinator – Supports COA Scientists to procure licenses for use of COA instruments, manage translations and electronic migrations, and to obtain copyright for Sanofi-developed COA instruments
In order to meet the needs of the business units and the multifunctional customer base, the COG team is looking to expand its team to include two additional experienced COA Scientists.
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 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
- 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 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
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
Requirements and Qualifications:
- Relevant advanced academic degree (e.g. PhD or masters in health economics, clinical psychology, public health, epidemiology, psychometrics)
- Training in COA methods
- At least 5 years of HEOR/CMO pharmaceutical industry, CRO or academic experience
- 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 (including real-world evidence (RWE) 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, 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)
- Starting date expected Q1- Q2 2020
- 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
Cambridge MA, USA; Bridgewater NJ, USA; Chilly-Mazarin (near Paris), France; or Lyon, France
The COG team is currently based between US and France.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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