CMC Demand & Supply Leader

Sanofi•Framingham, MA

4d•Onsite

About The Position

Within the CMC function, in the Global CMC Project Management department, the ambition is to expand a strong End to End R&D Supply Demand integrating Demand Forecast & Planning of Supplies, supporting Projects Development and Operations through the entire value chain (from R&D to LCM). With the aim of developing a Demand & Supply Center of Excellence, the mission of the Demand & Supply Leader is to integrate Project Strategy, Clinical and CMC Operational plans for an early definition and optimization of E2E Demand & Supply plan while considering cost & risk to support execution of Projects in respect to Regulatory and Quality requirements. This role offers the opportunity to join a dynamic and skilled team at a pivotal time as we strengthen our in-house expertise, accelerate digital transformation initiatives, and build sustainable internal capabilities to support an increasing portfolio of innovative projects across multiple therapeutic areas. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

PhD holders: Minimum 3 years in Research and Development or Clinical Development.
Master's holders: Minimum 5 years in Research and Development or Clinical Development.
Bachelor's holders: Minimum 8 years in Research and Development or Clinical Development.
Minimum 2 years in Demand Management in Research and Development in the domain of Oncology, Immuno-inflammation, Rare Disease, Neurology, or Multiple Sclerosis (included within total years of experience, not additional)
CMC experience.
Ability to navigate complex and regulated environments (GMP and GCP regulations)
Knowledge of data analytics and forecasting
Project Management experience

Nice To Haves

Experience in the development of diverse modalities (Mammalian, Genomic, Microbial, Synthetics)
Excellent knowledge of Projects Development, Clinical & Preclinical Development, Clinical Supply Chain, CMC, R&D and M&S interfaces
PMI certification
Experience in Power BI/Power App and project management software
Experience in management of co-development projects, companies' integration and contracts management
Knowledge of Industrial Supply Chain principles
Strong interpersonal/networking skills, team-work and transversal collaboration
Ability to understand complex processes quickly and act as referent for the department
Strong ability to work under pressure and address complex situations
Team management experience is a plus

Responsibilities

Lead collaborative work with Global project Management, Clinical Development and CMC to define clinical assumptions and CMC hypothesis to forecast Clinical Demand.
Forecast Long Range Plan Demand based on assumptions worked with interfaces.
Consolidate non-clinical & clinical demand and propagate to M&S Global Supply Chain.
Integrate all Development Demand and align with operational plans (CMC, CSO, TMED, DMPK, PCS) and Regulator submission/approval plans.
Run forecast & alignment scenario with associated risks and costs to support strategic project decisions and budget definition.
Co-lead Demand & Supply Sub Team and ensure End to End supply optimization with the contribution of key stakeholders.
Accountable for defining the best sourcing and supply strategy for marketed products/comparators, including forecast and budget.
Lead the definition of drug products blinding strategy to ensure clinical trial products indistinguishability.
Ensure DS/DP batches allocation to IMP batches and on time products delivery to packaging sites and oversee associated Material Flow & Documentation management.
Provide reporting/KPIs to monitor & improve Supply performance
Contribute to project documents & meetings preparation by providing standard Demand & Supply Reports (e.g. IDCC/DWG/ORC, IDP, Operational plan, Supply agreement).
Can support transversal initiatives contributing to simplification & harmonization.