MED is Department part of Industrial Affair (IA) responsible for the oversight of Device and Combination product design, Development and Launched for relevant Sanofi Units.
Early Stage Device Development is the unit responsible to lead and manage projects in an early stage before entry in late stage development.
Drug Device Combination Product Projects are managed across the phases with the goal of defining and executing out a robust and competitive device strategy. The clinical supply of a Drug Device Combination Product for early development phases might be part of the development project.
Technology Exploration Projects and Due Diligence Projects are conducted in close alignment to the overall company strategy and development pipeline needs.
Platform Development Projects are initiated and managed with the goal of building a solid foundation for future Drug Device Combination Products.
All activities are conducted in close collaboration with internal and external stakeholders like R&D, iCMC, Business Units, Manufacturing Sites and others
The Early Stage Device Project Leader leads the Device Team and is overall accountable to execute the project in scope, time, budget and quality in accordance with the Sanofi directives, guidelines and governance processes.
· Accountable for the success project including deliverables, timing and budget
· Owns the overall Device Development program strategy with Technologies at different level of maturity and risks
· Directs many external Partners, Sub-device Project Team in order to create of a robust device development strategy and manage critical path activities carefully.
· Lead the implementation of cross-functional teams to execute this strategy.
· Deploy patient-centered system design approach integrating of all components of the system architecture (formulation, primary container and delivery device incl. label* & packaging*).
· Represent MED and provide consolidated recommendations to CMC, Global Project Team and governance
· Academic Relationship - Represent Sanofi with the different University with Medical Device Technology
· Manage multiple Cross Functional Teams and Sub-Teams of more the 15 people in an international/Global perspective
· Motivate and encourage team members with the goal of creating an ambitious and technically rigorous team.
· Strong leadership in transversal project and teams: Able to provide vision, strategy, motivation and inspiration
· Proactively identify potential issues and manage cross-functional, cross-company and cross-cultural resolution
· Influencing and negotiation skills to build solutions and partnership
· Define objectives and deliverables and capable to deliver under high pressure
· Ability to synthesize and explain complex topics to non experts and to management; proven facility in oral communication
· Take responsibility for decisions and accountable for results
· Ability to interact effectively with executive/senior management and external bodies (e.g., auditors, health authorities, etc.)
· Empower, motivate and inspire team members and resolve issues escalated from them.
· Develop team members through the functional heads by proposing development opportunities as well as by providing input in appraisals.
BS Degree in engineering or life sciences ·
· 8 years of work experience in project management, including planning, scheduling, organizing
· Minimum of 7 years' experience (Working Knowledge) in drug-device combination development.
· Experience in more than 2 projects launched·
Preferably an advanced degree in engineering or life sciences
· Understanding of systems thinking (drug+ container+ device+ software+ app = system)
Expertise around regulatory requirements for parenteral CP is preferred (21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366)
· International business experience
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.