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 utilisation 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.
Consultation with regulators, payers and key opinion leaders is common.
Example research activities for the COG 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.
The COG team contains 3 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 Evaluation Specialist– Works to generate real world patient insights about treatment and drivers of behavior in routine clinical practice/pharmacy, and develop COA-based support tools for patients and healthcare professionals
· Clinical Outcome Assessment (COA) Expert Co-ordinator– Supports COA Scientists and Clinical Evaluation Specialists to procure licences for use of COA instruments, manage translations and electronic migrations, and to obtain copyright for Sanofi-developed COA instruments
COG Head Role Description
The COG Head will support the COA Scientists 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 of COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, validation and dissemination
- Develop novel COA instruments in line with industry best practice
The COG Head will support the Clinical Evaluation Specialists to:
- Generate a comprehensive understanding of treatment and drivers of patients’ disease- and treatment-related behavior in real world settings (e.g. routine clinical practice, pharmacy)
- Advise on the use and/or development of COA-based support tools to assist healthcare professionals and patients communicate and make decisions about treatment allocation, use, adherence, effectiveness, safety, and persistence
- Work collaboratively with other teams across Sanofi, including Digital Clinical
The COG Head will support the COA Expert Co-ordinator to:
- Secure licences for COA instrument use in Phase 2-4 research
- Commission and manage translations of COA instruments according to industry best-practice
- Advise on migration strategies for development of electronic COA instruments according to industry best-practice
Additional role activities for the Head of COG include:
- Manage budget and engage vendors to deliver to plan
- Conduct formal evaluation process for team members
- Participate in leadership activities within function (RWE & COG) and in the broader organization
- Represent Sanofi in external collaborations and forum, including IMI and the C-Path PRO Consortium
- Create and deliver 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.
COA Head qualifications, experience and skills needed
- Relevant advanced academic degree (e.g. doctorate or masters in health economics, clinical psychology, public health, epidemiology, psychometrics)
- Training in COA methods (qualitative, quantitative)
- At least 8 years of HEOR/CMO pharmaceutical industry, CRO or academic experience
- At least 5 years of relevant experience in COA
- At least 3 years of personnel management / leadership experience
- Proven track record in some COA disciplines incl. data analyses, scientific publication & input to clinical trials
- Experience of drug development lifecycle research (including RWE research)
- Experience of developing COA-based tools to regulatory standards
- Experience and knowledge in technology and digital tools for healthcare
- 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 and technology/digital tools
- Strong analytical and synthesis skills of qualitative and quantitative data, including an understanding of thematic analysis and neuro linguistic processing (NLP) for analyzing interview/textual data
- Excellent understanding of research principles and recent developments in COA
- Clear knowledge of epidemiology and RWE methods and regulation
- 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
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.