? Apply in 3 Minutes! Digital Biomarker Operational Lead Position Available In Morris, New Jersey

Job Description:

Job Title:

Digital Biomarker Operational Lead Location:

Cambridge, MA, Morristown, NJ About the Job Are you ready to shapethe future of medicine? The race is on to speed up drug discoveryand development to find answers for patients and their families.

Your skills could be critical in helping our teams accelerateProgress. The Clinical Innovation team at Sanofi is responsible foridentifying, accelerating, and scaling innovations that can serveto improve operations and/or outcomes for patients, sites, andsponsors of clinical trials. The Clinical Innovation team includesour digital biomarker strategy and operations team which focuses onestablishing and executing digital biomarker programs that generatehealth-related data through digital health technologies (DHTs),provide valuable insights into patients’ conditions, and aid inimproving the clinical trial experience. This role within theClinical Innovation Strategy and Implementation team will beresponsible for independently executing and implementing thedigital biomarker strategy within our clinical programs.

Specifically, the role will be responsible for ensuring theactivation, selection, implementation, and success of a digitalendpoint in a clinical study and/or program. Additionally, the rolewill be responsible for contributing insights, expertise, andperspective gained from day-to-day activities to the overallstrategy and innovation direction of the team. The DigitalBiomarker Operational Lead can manage several studies, and studieswith complexity level 3 proactively and independently and willmentor junior Digital Biomarker Operational Leads and GIGs to growinto the role. The Digital Biomarker Operational Lead can serve assubject matter expert on key topics, and can serve as back-up forthe Clinical Innovation Operations Portfolio Lead for someactivities spanning the Portfolio. A successful candidate will havea strong attention to detail, passion for driving innovation aswell as testing new technology solutions, comfort with andexperience with project management, good grasp of clinicaloperations, high flexibility and enthusiasm towards changingenvironment and a problem-solving attitude. The Digital BiomarkerOperational Lead will have a strong and long experience in clinicaldevelopment studies/ programs phase I, II III and IV and will havestanding vendor management experience. The Digital BiomarkerOperational Lead will focus on operationalizing the selectedDigital Health Technologies (DHTs) into our clinical studies. Therole is responsible for ensuring the successful execution of ourstrategic direction by working with global and local study teams toselect vendor(s), onboard and implement the vendor(s) with closeattention to study timelines and milestones. The Digital BiomarkerOperation Lead is responsible for ensuring all operationalcomponents of the digital biomarkers are accounted for and executedthrough study start-up, conduct, database lock, read-outs, andplanning for next phases as relevant. Digital Biomarker OperationalLeads report into the Clinical Innovation Operations Portfolio Leadand work closely with the Digital Endpoint Strategy Leads, ProjectLeads, Global Study Managers, Procurement, Vendor excellence,quality, regulatory, and other relevant teams to ensure studysuccess. The Digital Biomarker Operational Lead is expected todevelop deep familiarity with the digital health technology(s) theyare responsible for deploying to clinical studies. This familiarityand expertise will be essential for problem solving during anychallenges during study start-up or study conduct. Additionally,the Digital Biomarker Operational Lead will be expected toconfidently navigate ambiguity and to support the creation of SOPsfor new processes as digital health technologies are onboarded toSanofi’s studies. The Digital Biomarker Operational Lead isessential for communicating risks, lessons learned andopportunities for improvement to the clinical innovation team andstudy teams. We are an innovative global healthcare company withone purpose: to chase the miracles of science to improve people’slives. We’re also a company where you can flourish and grow yourcareer, with countless opportunities to explore, make connectionswith people, and stretch the limits of what you thought waspossible. Ready to get started?

Main Responsibilities:

The DigitalBiomarker Operational Lead will:

• Contribute to the selection andimplementation of digital health technologies to collect patientdata collection through wearables and connected devices in theclinical studies of the Development Portfolio
• Coordinate the useof the data for digital outcome assessments, digital endpointsand/or digital biomarkers with cross-functional Sanofi teams todeploy DHTs to our clinical studies
• Drive the methodologicalprocess for the use of digital assessments/endpoints/biomarkersacross the Sanofi Clinical Development portfolio, in line withglobal development objectives
• Enable study teams tooperationalize the digital collection of patient’s generated datain all stages of study execution: design, set up, conduct, analysis
• Contribute to the development and review of repeatable processesand tools for the implementation and management of DigitalBiomarkers in the clinical trials Support clinical developmentteams to integrate digital biomarkers in the clinical studies:
• Share operational, scientific and regulatory related knowledgeabout the digital biomarkers with clinical study teams asapplicable and needed
• Build a proposal (digital device/vendor) inalignment with the clinical study /program’s need
• Facilitate thedevelopment of Digital Biomarkers validation plan as needed andconnect the clinical study team with the appropriate functionallowing its development
• Support/ Lead study teams in thepreparation and operational implementation of digital biomarkers intheir studies Develop Digital Biomarker knowledge and expertise:
• Gather all internal / external information through interaction withvendors and departments involved (Clinical Dev, Regulatory Affairs,Patient Perspective, Competitive Intelligence, BD, alliancemanagers…)
• Share key information with Project teams, andTherapeutic Area teams as relevant to their clinical innovation anddigital biomarker needs
• Educate study teams and peers aboutDigital Biomarker requirements for implementation and use inclinical trials Vendor management:
• Drive selection of appropriatevendors for digital biomarkers and work closely with externalservice providers to ensure successful delivery, in collaborationwith accountable departments
• Manage and monitor status of vendorqualification and onboarding
• Ensure study deliverables arealigned with cost, timelines, and quality requirements.

Define andmonitor project milestones and metrics.

Transverse role:

• Collectinternally and externally best practices/ lessons learned, that canbenefit the long-term strategy
• Work transversally to ensurealignment between vendors and Sanofi teams
• Present DigitalBiomarker Mission, Vision, implementation and management to broaderCSO audience as needed and applicable Mentoring Junior DigitalBiomarker Operational Leads
• Support Junior Digital BiomarkerOperational Leads to manage their responsibilities in the assignedstudies, ensuring complete coverage of all required tasks
• Trainthe Junior Digital Biomarker Operational Leads in the skills andbasic principles of clinical development
• Support the ClinicalInnovation Portfolio Lead in developing training materials tosupport junior staff Act as an internal change agent, encouragingan innovative and agile mindset. About You Knowledge, Skills &Competencies / Language
• Scientific knowledge and skills with astrong capacity for in-depth analysis of complex data/environment
• Experience and knowledge of clinical operations in complexinnovative and scientific setting
• Customer facing skills,networking with different roles in and outside CSO
• Stronginterest in digital health technologies
• Ability to envision newways of working, comfort with innovation and agility
• Organization, flexibility and prioritization skills, ability tomanage multiple projects in parallel and proactive and solutionoriented
• Ability to create and maintain a collaborativeenvironment
• Leadership and influencing skills
• Results andmetrics oriented, commitment to excellence
• Strong verbal andwritten communication skills

Knowledge and Skills Desirable But NotEssential:

• Data Analysis / Bio-Statistics
• Patients profile andsymptoms / Disease-specific endpoints and outcomes in anytherapeutic area
• Vendor management / outsourcing Qualifications
• 5 years of operational experience in Global Study Management orother relevant role in clinical development
• Digital HealthTechnology experience is not required, but an asset
• Scientific/medical background
• Advanced and Fluent Englishskillsets Why Choose Us?
• Bring the miracles of science to lifealongside a supportive, future-focused team.
• Discover endlessopportunities to grow your talent and drive your career, whetherit’s through a promotion or lateral move, at home orinternationally.
• Enjoy a thoughtful, well-crafted rewards packagethat recognizes your contribution and amplifies your impact.
• Takegood care of yourself and your family, with a wide range of healthand 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. affiliatesare Equal Opportunity and Affirmative Action employers committed toa culturally diverse workforce. All qualified applicants willreceive 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 militarystatus; domestic violence victim status; atypical cellular or bloodtrait; genetic information (including the refusal to submit togenetic testing) or any other characteristic protected by law.

GD-SA LI-SA

LI-Onsite vhd All compensation will be determinedcommensurate with demonstrated experience. Employees may beeligible to participate in Company employee benefit programs, andadditional benefits information can be found here.