Digital Biomarker Operational Lead

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.

Sanofi is driving the future of medicine by accelerating drug discovery and clinical development. The Clinical Innovation team plays a pivotal role by identifying, accelerating, and scaling innovations that enhance clinical trial outcomes and experiences for patients, sites, and sponsors. One of its key functions is the Digital Biomarker Strategy and Operations Team, which leads efforts to incorporate Digital Health Technologies (DHTs) into clinical programs to generate health-related data, improve patient insights, and optimize study operations.

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 is a transversal role focused on operationalizing selected Digital Health Technologies (DHTs) into our clinical studies for our growing digital biomarker program. 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.

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.

As a Digital Biomarker Operational Lead (Associate Director level), you will be responsible for operationalizing Sanofi’s digital biomarker strategy across multiple clinical studies and phases (I-IV). This includes vendor selection, study-level implementation, cross-functional coordination, risk mitigation, and ensuring alignment with broader innovation strategies. 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. You will also contribute to internal process development and act as a mentor to junior operational leads.

Main Responsibilities:

Digital Biomarker Program Execution

· Lead the end-to-end operationalization of digital biomarkers in clinical trials, including:

o Vendor identification, selection, onboarding, and management.

o Study planning and execution from start-up to database lock and readouts.

o Alignment with timelines, budgets, and quality requirements.

· Responsible for ensuring all operational components of DHTs are accounted for and integrated effectively into clinical programs.

· Serve as a subject matter expert for the study team on matters of digital biomarker operationalization and study execution

· Identify and resolve operational and logistical challenges elements that may be unique to clinical study execution including DHTs to ensure timely and efficient study execution

· Comfort and confidence leading DHT operations for studies of varying complexities

Strategic & Cross-Functional Collaboration

· Collaborate and communicate efficiently with global and local study teams, Digital Endpoint Strategy Leads, Project Leads, Study managers, Procurement, Regulatory, Quality, and others.

· Lead and contribute detailed project management specific to the DHT components of clinical studies

· Act as subject matter expert (SME) on digital biomarkers and DHTs.

· Provide strategic insights and contribute to the evolution of Sanofi’s innovation roadmap

Knowledge Development & Change Management

· Develop expertise in DHTs used in studies; assist with SOP creation for new technologies.

· Communicate risks, lessons learned, and improvement opportunities.

· Promote a culture of agility, experimentation, and innovation

Clinical Study Team Enablement

· Support teams in study design, set-up, conduct, analysis, and integration of digital data.

· Share scientific, operational, and regulatory knowledge relevant to digital biomarkers.

· Assist in building validation plans and connect teams with required resource

Process Optimization

· Develop and improve repeatable processes and tools for digital biomarker implementation.

· Collect and share internal and external best practices.

· Drive vendor qualification, contracting, and onboarding.

· Monitor progress and performance against milestones, budgets, and quality metrics.

Act as an internal change agent, encouraging an innovative and agile mindset.

Training & Communication

· Support and mentor junior Digital Biomarker Operational Leads.

· Assist with development of training materials and skills-building programs.

· Represent the Digital Biomarker function in internal forums and cross-functional initiatives.

· Present updates and outcomes to leadership and broader stakeholders as needed

About You

Required Qualifications

· 5+ years of operational experience in global study management or related clinical development roles.

· Background in life sciences and/or clinical operations, study management, or medical research operations

· Strong project management skills and ability to work across multiple studies simultaneously.

Preferred Skills & Experience

· Experience in clinical trials spanning phases I-IV.

· Prior involvement with digital health technologies (DHTs) is an asset.

· Vendor management and outsourcing experience.

· Familiarity with regulatory and operational aspects of digital endpoints or biomarkers.

· Bio-statistical and/or data analysis capabilities (optional).

Previous experience in the role of any of the following

o Clinical Operations Lead, Clinical Project Manager, Clinical Study Manager, Global Study Manager, Clinical Trial Manager, Manager Clinical Development, Medical Research Operations, Clinical Research Scientist

o Earlier experience: Clinical Research Associate, Clinical Project Associate, Research Project Coordinator, Study Monitor, Clinical Trial Coordinator, Clinical Trial Specialist, Study Coordinator

o Digital health technology operations and implementation

Core Competencies

· Strong analytical thinking and attention to detail.

· Leadership and influencing skills in a cross-functional matrix.

· Excellent verbal and written communication.

· High adaptability, organizational skills, and solution orientation.

· Passion for innovation and continuous improvement.

· Collaborative mindset and ability to mentor other

· Bachelor’s degree or equivalent experience required, advanced degree in business, operations, data, or relevant areas a plus

· Fluent in English (written and spoken)

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.

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