Country Quality Manager

Sanofi is a leading bio-pharmaceutical company committed to advancing healthcare through groundbreaking research and development. 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 is a director level role that will focus on utilizing DHTs and related data to create digital endpoints in clinical trials, ensuring accurate evaluation of treatment outcomes, and advancing Sanofi's scientific understanding of disease. As we continue to drive excellence and innovation in our clinical trials, we are seeking an exceptional professional to join us as a Clinical Strategy Lead for Digital Endpoints.

Job Overview:

The Clinical Strategy lead for Digital Endpoints drives and augments Sanofi’s success in R&D by defining and executing innovative digital biomarker strategies across our R&D portfolio. The role is responsible for end-to-end integration with clinical studies, and the role identifies, creates, validates, and operationalizes both fit-for-purpose and novel digital endpoints in Sanofi’s clinical studies. Collaborating across teams, the role ensures seamless integration of therapeutic area needs with cutting-edge technologies, delivering impactful solutions to patients and enhancing our clinical programs. Additionally, the role will contribute to identifying, testing, and adopting new technologies that show promise for clinical digital measurement and growing Sanofi’s digital biomarker expertise and thought leadership.

Key Responsibilities:

Digital Endpoint Strategy Development and Execution:

• Identify opportunities for digital endpoint/outcomes strategies in collaboration with clinical teams to integrate novel and fit for purpose digital measures into clinical studies.

• The role will work closely with the therapeutic area teams to understand the strategic needs across Sanofi’s portfolio, and the role will be responsible for establishing and understanding the DHTs available to create value for patients, programs, and operations.

• The role will also communicate the respective value and potential of the available DHTs to development and partner teams and throughout all stages of the lifecycle of a drug.

• Lead cross-functional teams in creating integrated plans to develop, validate, and deploy digital endpoints.

• The role will be responsible for recommending digital endpoints and driving the cross-functional teams to select or design the respective DHT both to address meaningful aspects of health and to add value to Sanofi’s development portfolio.

• Operationalize digital endpoint strategy programs and serve as the primary point of contact, organize and manage multi-workstream efforts to meet strategic goals.

• The role will be responsible for creating and executing the integrated validation and testing plans to support strategic study timelines and goals.

• Additionally, the role will create and implement KPIs, and communication strategies to inform leadership of milestones, and results.

• The role will work closely with the Digital Biomarker Operational Leads and to ensure the operational needs for each study are defined, communicated, and executed.

• Integrate essential inputs such as health authority feedback, legal, intellectual property, data use, and privacy considerations into the Digital Endpoint strategy to ensure feasibility.

• Revise and communicate strategic and operational plans when appropriate while ensuring the patients’ needs are at the core of the deliverables.

External representation:

• Represent Sanofi Clinical Innovation internally and externally to the biopharma and digital biomarker communities.

• Communicate the potential and value of digital biomarkers, educate about the processes and considerations when incorporating digital endpoints into programs and studies, and recommend opportunities for innovation.

Drive the Clinical Innovation team forward:

• Contribute to the growth of the digital biomarker organization, identify unmet needs within the organization with respect to process and strategy, propose and execute solutions.

• Collaborate to deliver agile and effective change management.

• As an expert, remain up to date on the internal digital endpoints portfolio, on current and emerging technologies, industry milestones, and regulatory impacts.

Matrixed Leadership and Change Management:

• Effectively lead innovation and transformation projects within the department, and in collaboration with other teams, fostering a culture of innovation, collaboration, and continuous learning.

Stakeholder Collaboration:

• Collaborate with and lead cross-functional teams, including but not limited to Clinical Research Directors, Regulatory Affairs, Clinical operations, Research, Digital, Medical Affairs, and Health Economics and Value and Access to align digital measurement innovation efforts with overall business goals.

Performance Metrics:

• Define key performance indicators (KPIs) and establish metrics to measure the success of innovation and transformation initiatives.

• Regularly report progress to senior management.

About you:

Qualifications and Experience:

Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field) and 10+ years of relevant experience OR

Master's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field) and 5+ years of relevant experience OR

PhD or PharmD in a scientific discipline (Chemistry, Biology, Pharmacy, or related field) and 3+ years of relevant experience.

Relevant experience includes Life sciences, pharmaceuticals, clinical data analysis, clinical trial design, medical imaging, novel endpoint design, clinical outcomes assessments, academia, or related field and/or digital health technologies contributing to a solid grasp of the intersection of clinical development and digital health technologies.

• Strong knowledge of digital health technologies and/or digital measurements in clinical trials and regulated settings. Foundational understanding and working knowledge of diseases, symptomology, and relevant assessments such as clinical outcomes assessments and biomarkers.

• Proven track record of driving innovation and executing complex cross-functional digital projects, identifying opportunities and leading teams to new adopting new technology solutions.

• Strong knowledge in the fields of GXP, data and data science, data management, diseases area, R&D organizations in biopharma, USA and EU health authorities, user experience and user acceptance testing. Any additional expertise in one or more of these areas is preferred

• Excellent leadership and stakeholder management skills, with experience in a matrixed environment

• Demonstrated ability to think strategically, identify opportunities, and implement effective solutions.

• Exceptional communication and interpersonal skills, capable of collaborating with stakeholders at all levels of the organization. Excel at storytelling and integrating complex, multi-disciplinary workstreams to present recommended actions.

• Demonstrated ability to manage multiple projects simultaneously and work effectively under tight timelines.

Languages: Fluency in spoken and written English required

Location: Cambridge, MA, USA, Morristown, NJ, USA

Travel Requirements-10-20%

If you are a visionary leader with a passion for transforming patient care using digital health technology and driving innovation in pharmaceutical clinical trials, we encourage you to apply for this exciting opportunity. Join our team and contribute to our mission of improving patient outcomes through cutting-edge therapies.

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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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.