
Digital Biomarker Operational Lead
Cambridge, MassachusettsMorristown, New Jersey Permanent Posté le Jun. 03, 2025 Expire le Oct. 03, 2025 Salary Range USD 147,000.00 - 212,333.33
Job Title: Digital Biomarker Operational Lead
Location: Cambridge, MA, Morristown, NJ
About the Job
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. Your skills could be critical in helping our teams accelerate progress.
The Clinical Innovation team at Sanofi is responsible for identifying, accelerating, and scaling innovations that can serve to improve operations and/or outcomes for patients, sites, and sponsors of clinical trials. The Clinical Innovation team includes our digital biomarker strategy and operations team which focuses on establishing and executing digital biomarker programs that generate health-related data through digital health technologies (DHTs), provide valuable insights into patients' conditions, and aid in improving the clinical trial experience.
This role within the Clinical Innovation Strategy and Implementation team will be responsible for independently executing and implementing the digital biomarker strategy within our clinical programs. Specifically, the role will be responsible for ensuring the activation, selection, implementation, and success of a digital endpoint in a clinical study and/or program. Additionally, the role will be responsible for contributing insights, expertise, and perspective gained from day-to-day activities to the overall strategy and innovation direction of the team.
The Digital Biomarker Operational Lead can manage several studies, and studies with complexity level 3 proactively and independently and will mentor junior Digital Biomarker Operational Leads and GIGs to grow into the role.
The Digital Biomarker Operational Lead can serve as subject matter expert on key topics, and can serve as back-up for the Clinical Innovation Operations Portfolio Lead for some activities spanning the Portfolio.
A successful candidate will have a strong attention to detail, passion for driving innovation as well as testing new technology solutions, comfort with and experience with project management, good grasp of clinical operations, high flexibility and enthusiasm towards changing environment and a problem-solving attitude.
The Digital Biomarker Operational Lead will have a strong and long experience in clinical development studies/ programs phase I, II III and IV and will have standing vendor management experience.
The Digital Biomarker Operational Lead will focus on operationalizing the selected Digital Health Technologies (DHTs) into our clinical studies. The role is responsible for ensuring the successful execution of our strategic direction by working with global and local study teams to select vendor(s), onboard and implement the vendor(s) with close attention to study timelines and milestones. The Digital Biomarker Operation Lead is responsible for ensuring all operational components of the digital biomarkers are accounted for and executed through study start-up, conduct, database lock, read-outs, and planning for next phases as relevant. Digital Biomarker Operational Leads report into the Clinical Innovation Operations Portfolio Lead and work closely with the Digital Endpoint Strategy Leads, Project Leads, Global Study Managers, Procurement, Vendor excellence, quality, regulatory, and other relevant teams to ensure study success.
The Digital Biomarker Operational Lead is expected to develop deep familiarity with the digital health technology(s) they are responsible for deploying to clinical studies. This familiarity and expertise will be essential for problem solving during any challenges during study start-up or study conduct. Additionally, the Digital Biomarker Operational Lead will be expected to confidently navigate ambiguity and to support the creation of SOPs for new processes as digital health technologies are onboarded to Sanofi’s studies. The Digital Biomarker Operational Lead is essential for communicating risks, lessons learned and opportunities for improvement to the clinical innovation team and study teams.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
The Digital Biomarker Operational Lead will:
Contribute to the selection and implementation of digital health technologies to collect patient data collection through wearables and connected devices in the clinical studies of the Development Portfolio
Coordinate the use of the data for digital outcome assessments, digital endpoints and/or digital biomarkers with cross-functional Sanofi teams to deploy DHTs to our clinical studies
Drive the methodological process for the use of digital assessments/endpoints/biomarkers across the Sanofi Clinical Development portfolio, in line with global development objectives
Enable study teams to operationalize the digital collection of patient’s generated data in all stages of study execution: design, set up, conduct, analysis
Contribute to the development and review of repeatable processes and tools for the implementation and management of Digital Biomarkers in the clinical trials
Support clinical development teams to integrate digital biomarkers in the clinical studies:
Share operational, scientific and regulatory related knowledge about the digital biomarkers with clinical study teams as applicable and needed
Build a proposal (digital device/vendor) in alignment with the clinical study /program’s need
Facilitate the development of Digital Biomarkers validation plan as needed and connect the clinical study team with the appropriate function allowing its development
Support/ Lead study teams in the preparation and operational implementation of digital biomarkers in their studies
Develop Digital Biomarker knowledge and expertise:
Gather all internal / external information through interaction with vendors and departments involved (Clinical Dev, Regulatory Affairs, Patient Perspective, Competitive Intelligence, BD, alliance managers…)
Share key information with Project teams, and Therapeutic Area teams as relevant to their clinical innovation and digital biomarker needs
Educate study teams and peers about Digital Biomarker requirements for implementation and use in clinical trials
Vendor management:
Drive selection of appropriate vendors for digital biomarkers and work closely with external service providers to ensure successful delivery, in collaboration with accountable departments
Manage and monitor status of vendor qualification and onboarding
Ensure study deliverables are aligned with cost, timelines, and quality requirements. Define and monitor project milestones and metrics.
Transverse role:
Collect internally and externally best practices/ lessons learned, that can benefit the long-term strategy
Work transversally to ensure alignment between vendors and Sanofi teams
Present Digital Biomarker Mission, Vision, implementation and management to broader CSO audience as needed and applicable
Mentoring Junior Digital Biomarker Operational Leads
Support Junior Digital Biomarker Operational Leads to manage their responsibilities in the assigned studies, ensuring complete coverage of all required tasks
Train the Junior Digital Biomarker Operational Leads in the skills and basic principles of clinical development
Support the Clinical Innovation Portfolio Lead in developing training materials to support junior staff
Act as an internal change agent, encouraging an innovative and agile mindset.
About You
Knowledge, Skills & Competencies / Language
Scientific knowledge and skills with a strong capacity for in-depth analysis of complex data/environment
Experience and knowledge of clinical operations in complex innovative and scientific setting
Customer facing skills, networking with different roles in and outside CSO
Strong interest in digital health technologies
Ability to envision new ways of working, comfort with innovation and agility
Organization, flexibility and prioritization skills, ability to manage multiple projects in parallel and proactive and solution oriented
Ability to create and maintain a collaborative environment
Leadership and influencing skills
Results and metrics oriented, commitment to excellence
Strong verbal and written communication skills
Knowledge and Skills Desirable But Not Essential:
Data Analysis / Bio-Statistics
Patients profile and symptoms / Disease-specific endpoints and outcomes in any therapeutic area
Vendor management / outsourcing
Qualifications
5+ years of operational experience in Global Study Management or other relevant role in clinical development
Digital Health Technology experience is not required, but an asset
Scientific/medical background
Advanced and Fluent English skillsets
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good 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
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Toujours progresser. Découvrir l’extraordinaire.
Le progrès ne se fait pas tout seul, ce sont les gens qui le construisent : des gens d'horizons différents, dans des lieux différents, dans des rôles différents, mais tous réunis par une même motivation : la volonté de rendre l’impossible possible. Et si vous rejoigniez cet élan ? Afin de poursuivre le changement, adopter de nouvelles idées et explorer toutes les opportunités que nous avons à offrir. Ensemble, continuons de progresser. Et partons à la découverte de l'extraordinaire.
Chez Sanofi, nous croyons en l’égalité des chances pour tout le monde, indépendamment de l’origine, de la couleur de peau, des croyances, du genre, de l'orientation sexuelle, de l'âge, de la citoyenneté, de l'état civil, du handicap ou de l’identité de genre.
Regardez « Une journée type chez Sanofi » et découvrez nos initiatives en matière de diversité, d'équité et d'inclusion sur sanofi.com
Vous n'avez pas encore consulté aucune d'offres d'emploi
Vous n'avez pas encore enregistré d'offres d'emploi.

Carrières Sanofi aux USA
Rejoignez notre équipe américaine pour profiter d’un mentorat d’experts et de plateformes de formation, en accord avec notre culture. Votre passion et votre énergie seront mises à profit pour créer des vaccins et des médicaments qui réduisent de moitié le délai entre la découverte et la thérapie.
En savoir plus
sur ce site
Un monde de possibilités
-
-
-
Quand vous évoluez, nous évoluons avec vous
Nous nous engageons à vous soutenir à travers une politique de rémunération complète, soigneusement élaborée pour contribuer à votre bien-être physique, financier, mental et social. Peu importe votre rôle, vous vous épanouirez au sein de nos équipes inclusives.
-
Construisez une carrière qui a du sens
Exprimez votre passion et impactez des millions de personnes à travers le monde. Vous êtes aux commandes : fixez vos objectifs et nous vous offrirons la formation et le soutien nécessaires pour les atteindre.
-
Lancez votre carrière
Explorez les possibilités : apprentissage, stages, postes pour jeunes diplômés, mobilité internationale. Vous serez accompagné pour avoir un impact significatif.
-
Nos sites
Nous sommes présents dans plus de 60 pays, tous unis pour définir l'avenir de la santé. Votre carrière évoluera aux côtés d'experts et grâce à la technologie au service des plus grandes avancées.
-
Sanofi Stories
At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.
-
Pourquoi Sanofi ?
Accédez aux outils, à la formation et au soutien nécessaires pour atteindre vos objectifs. En réalisant votre plein potentiel, vous nous aiderez à atteindre notre objectif de réduire de moitié le temps entre la découverte et la thérapie.
-
Nos collaborateurs et notre culture
Audace, fierté et détermination sont les mots d'ordre. Des mesures concrètes sont prises pour que chaque Sanofien réussisse. La diversité est notre atout. Vous pouvez façonner notre avenir.
-
-
-
Meet Azer Hallabi, Project Manager, Global Regulatory Affairs
Discover the dynamic world of regulatory affairs with Azer Hallabi, Project Manager in Global Regulatory Affairs at our Budapest Hub.
-
Meet Nils Libert, Associate Scientist in R&D
Meet Nils Libert, an Associate Scientist contributing to groundbreaking research in R&D, Belgium.
-
Meet Orsolya Dina, Receivables & Revenue Team Lead
Follow Orsolya Dina’s inspiring journey as she embraces new opportunities for growth and advancement.
-
Meet Stefanie Van Poucke, GMP QA Head
Join Stefanie Van Poucke as she navigates the world of Quality Assurance, leading GMP QA efforts in R&D, Belgium.
-
Meet Robin, Digital Product Owner, Belgium
Dive into the digital world with Robin Meuris, as he discusses his role as a Digital Product Owner in Belgium.
-
Meet Ádám Honvéd, Product Owner Process Analytics
Step into the world of analytics with Ádám Honvéd as he shares his journey as a Product Owner for Process Analytics at our Budapest Hub.
-
Dachuan Li: From Operating Room to Medical Education
Dachuan Li traded his surgical scrubs for a career bridging science and healthcare as a Medical Science Liaison (MSL) in China.
-
Julien Guyomard: From Cars to COVID to Canada
How seizing opportunities built a global career. Julien's career in communications has taken him from the production lines of French car factories to the global stage of the Paris 2024 Olympics and finally to leading communications in Canada.
-
Vincent Dufauret: Embracing the Unexpected - Building a Versatile Career
Currently Global Digital Communication Project Lead, Vincent reflects on his diverse career journey. He shares the insights he wishes he'd understood from the beginning.

Rejoignez notre communauté
de talents
Que pourrions-nous accomplir ensemble ? Chaque Sanofien travaille sur des projets qui ont un véritable impact sur la vie des gens.
Inscrivez-vous dès aujourd'hui et découvrez nos dernières opportunités dès qu'elles seront disponibles.