Sanofi
Overview
Job Title:
Senior Clinical Outcomes Assessment (COA) Lead Location:
Cambridge, MA, Morristown, NJ Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. 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 utilization of COAs and other methods. The COA team is part of Sanofi's Global Research and Development (R&D) and reports into the Patient-Informed Development & Health Value Translation (PID&HVT) department. Consultation with regulators and key opinion leaders is common. Example research activities for the COA team include the development of a disease conceptual model; the selection of COA instruments to measure specific concepts of interest; the psychometric assessment of the measurement properties of COA instruments; the development and validation of new COA instruments; and the development of briefing books or dossiers for regulatory consideration of COAs. Internal customers include primarily Research and Development (R&D), Health Economics and Value Assessment (HEVA), and also Medical Affairs, Market Access, Biostatistics, and Commercial. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We offer opportunities to explore, connect, and grow your career. Ready to get started?
Main Responsibilities
The COA Lead is accountable for the definition of COA endpoint strategies and responsible for the conduct of related activities in relation to specific programs, assets or indications. The scope evolves as the COA Lead gains experience in the role and demonstrates ability to take on more in quantity (TA portfolio), impact (primary and key secondary endpoints) and exposure (strategic assets or indications). In addition to serving as COA Lead on a portfolio of programs, the Senior COA Lead provides expertise and strategic input within the COA team and beyond. They ensure alignment of COA strategies to external standards (e.g., PFDD), internal organization and priorities, and trends in the environment and competition. The Senior COA Lead actively participates in regulatory and commercial dynamics specific to TA, defines and communicates the TA strategic framework, including Core Outcomes Sets and Digital endpoint strategy, and provides guidance and support to COA scientists. The Senior COA Lead is accountable for the scientific quality of activities and deliverables in their scope, coaching less experienced COA scientists, leading internal educational programs, reviewing documents, representing the COA team in asset and indication strategy meetings, and in FDA meetings on invitation. The Senior COA Lead may take direct accountability for some assets with support from COA scientists. Expertise: The Senior COA Lead delivers senior expertise across the team in methodologies such as Psychometrics, Preference studies, Qualitative Research, Regulatory perspective and Endpoint definition. Innovation: The Senior COA Lead takes accountability for strategic transversal projects with support from the COA Lead. Exposure: The Senior COA Lead represents the COA team in cross-functional initiatives (e.g., with CSO, EDO, DBM) and represents Sanofi in consortia and pre-competitive initiatives (e.g., C-Path).
About You
Senior COA Lead qualifications, experience and skills needed Experience 5+ years relevant experience in COA in Pharma/CRO/Consultancy Ideally proven track record from scientific publications in core COA disciplines such as COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environment Qualification Relevant advanced academic degree (e.g., doctorate or master's in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics, etc.) Soft and technical skills Appetite for innovation and change management Ability to interact and manage external and internal networks Education Relevant advanced academic degree (e.g., doctorate or master degree in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics, etc.)
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team. Discover opportunities to grow your talent and advance your career, including promotions or lateral moves, at home or internationally. Enjoy a thoughtful rewards package that recognizes your contribution and amplifies your impact. Take care of yourself and your family with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks\' gender-neutral parental leave.
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.
#GD-SA #LI-SA
#LI-Onsite #vhd
Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn\'t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\'s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital 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.
North America Applicants Only The salary range for this position is: $172,500.00 - $249,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
#J-18808-Ljbffr
Job Title:
Senior Clinical Outcomes Assessment (COA) Lead Location:
Cambridge, MA, Morristown, NJ Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. 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 utilization of COAs and other methods. The COA team is part of Sanofi's Global Research and Development (R&D) and reports into the Patient-Informed Development & Health Value Translation (PID&HVT) department. Consultation with regulators and key opinion leaders is common. Example research activities for the COA team include the development of a disease conceptual model; the selection of COA instruments to measure specific concepts of interest; the psychometric assessment of the measurement properties of COA instruments; the development and validation of new COA instruments; and the development of briefing books or dossiers for regulatory consideration of COAs. Internal customers include primarily Research and Development (R&D), Health Economics and Value Assessment (HEVA), and also Medical Affairs, Market Access, Biostatistics, and Commercial. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We offer opportunities to explore, connect, and grow your career. Ready to get started?
Main Responsibilities
The COA Lead is accountable for the definition of COA endpoint strategies and responsible for the conduct of related activities in relation to specific programs, assets or indications. The scope evolves as the COA Lead gains experience in the role and demonstrates ability to take on more in quantity (TA portfolio), impact (primary and key secondary endpoints) and exposure (strategic assets or indications). In addition to serving as COA Lead on a portfolio of programs, the Senior COA Lead provides expertise and strategic input within the COA team and beyond. They ensure alignment of COA strategies to external standards (e.g., PFDD), internal organization and priorities, and trends in the environment and competition. The Senior COA Lead actively participates in regulatory and commercial dynamics specific to TA, defines and communicates the TA strategic framework, including Core Outcomes Sets and Digital endpoint strategy, and provides guidance and support to COA scientists. The Senior COA Lead is accountable for the scientific quality of activities and deliverables in their scope, coaching less experienced COA scientists, leading internal educational programs, reviewing documents, representing the COA team in asset and indication strategy meetings, and in FDA meetings on invitation. The Senior COA Lead may take direct accountability for some assets with support from COA scientists. Expertise: The Senior COA Lead delivers senior expertise across the team in methodologies such as Psychometrics, Preference studies, Qualitative Research, Regulatory perspective and Endpoint definition. Innovation: The Senior COA Lead takes accountability for strategic transversal projects with support from the COA Lead. Exposure: The Senior COA Lead represents the COA team in cross-functional initiatives (e.g., with CSO, EDO, DBM) and represents Sanofi in consortia and pre-competitive initiatives (e.g., C-Path).
About You
Senior COA Lead qualifications, experience and skills needed Experience 5+ years relevant experience in COA in Pharma/CRO/Consultancy Ideally proven track record from scientific publications in core COA disciplines such as COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environment Qualification Relevant advanced academic degree (e.g., doctorate or master's in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics, etc.) Soft and technical skills Appetite for innovation and change management Ability to interact and manage external and internal networks Education Relevant advanced academic degree (e.g., doctorate or master degree in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics, etc.)
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team. Discover opportunities to grow your talent and advance your career, including promotions or lateral moves, at home or internationally. Enjoy a thoughtful rewards package that recognizes your contribution and amplifies your impact. Take care of yourself and your family with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks\' gender-neutral parental leave.
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.
#GD-SA #LI-SA
#LI-Onsite #vhd
Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn\'t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\'s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital 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.
North America Applicants Only The salary range for this position is: $172,500.00 - $249,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
#J-18808-Ljbffr