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.

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.

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