Clinical Outcomes Assessment Scientist
Posted on: November 23, 2021
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
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
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.
In order to meet the needs of the business units and the
multifunctional customer base, the PCIOI team is looking to expand
its team to include additional experienced COA Scientists.
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
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
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
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
Relevant advanced academic degree (e.g. doctorate or masters in
health economics, clinical psychology, public health, epidemiology,
Training in COA methods.
At least 5 years of HEOR/CMO pharmaceutical industry, CRO or
At least 3 years of relevant experience in COA.
Proven track record in some COA disciplines including 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
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
Ability to work effectively either in small teams or
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
Identify new opportunities to integrate PRO/COA strategy further
-upstream ' in clinical development life cycle (i.e. Ph I).
Mentoring of entry level personnel.
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
Keywords: Sanofi, Trenton , Clinical Outcomes Assessment Scientist, Other , Bridgewater, New Jersey
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