Michael Klein Email & Phone Number

Paris, France, Fr

In my role as group head, I ensure the training, coaching, motivation, and development of individuals, driving the efficiency of my team to conduct studies and deliver Investigational Medicinal Products (IMP) within corporate KPIs. I provide strong support in clinical trial supply management, proactively and effectively monitoring my team's activity to maximize their capabilities, performance, and overall utility. Additionally, I develop people and their training to adapt to Sanofi's ongoing digital transformation and use of AI.As a CS TAGH, I am responsible for ensuring effective oversight of project and study management in the therapeutic areas I oversee, ensuring study and project process standardization, identifying synergies within all studies/programs of the TA, and monitoring adherence to clinical milestones and budget. I also instill an inspection readiness mindset within my team, ensuring oversight of the preparation and responses to audit/inspection reports for findings. Additionally, I ensure that evolution of the Therapeutic Area is well understood by CSCO leadership and implement long term strategic plans as new modalities enter the Rare and Rare Blood areas within Sanofi's pipeline. In this role, I execute excellent communication, negotiation, and problem-solving skills. I am highly organized utilizing effective time management and project management methods.

Paris, France, Fr

The clinical supply optimization specialist is accountable for identifying optimized study designs, production plans, IRT strategies, and distribution networks to improve project costs and lead times. Our team identifies innovative and disruptive approaches to reduce program budgets and increase productivity.The CSOS is an expert of the N-Side Supply App (power user), Randomization and IRT design, and project management. Additionally, the CSOS serves as a consultant to clinical supply teams across all active programs in the Sanofi portfolio for best practices and implementation of optimized strategies.

Paris, France, Fr

Power User of N-Side Supply App and serve as SME for US clinical supply management team/portfolio.o Review supply plans and protocols for US Team.o In accordance with the inputs from various functions, oversee the optimization of all production plans and IRT setups. o Provide support in protocol design, study setup, and distribution network optimization to minimize the study budget, increase kit utilization, and reduce overageTSOMo Serve as the single point of contact to the clinical team on behalf of the clinical supplies organization. o Determine and create optimal and accurate clinical supply demand models aligned to the protocol, study requirements, enrollment, and KPIs. Agree projections with actual patient enrollment throughout trials to ensure efficient use of IMP supply and reduce overage.o Oversee training of local teams and CRAs in regards to IMP handling and preparation.o Oversee setup of IRT, IRT spec design, and UAT.

Waltham, Massachusetts, Us

Collaboration Experience:o Serve as the global project lead for clients, managing internal packaging and distribution resources, external CROs, and IRT providers ensuring focus on program deliverables and client satisfaction. Provide consistent communication of clinical trial material supply status with internal and client project teams.o Utilize comprehensive understanding of best practices for clinical supply chain management to develop and improve existing business practices for CSOS. Develop and revise appropriate training material to support innovative processes. Mentor and coach associates on standard operating procedures relevant to clinical supply chain, regulatory requirements, cGMPs, and GCPs.Clinical Supply Chain Project Management Experience:o Design and implement long term strategic plans to supply complex global clinical trials across all clinical phases: o Provide input on clinical protocols, pharmacy manuals, and study start-up presentations.o Develop data-driven supply plans from drug product manufacturing to final patient kits at program level. o Design packaging, distribution, and blinding strategy in accordance with the study protocol for efficient use of material and resources.o Plan and manage study execution of clinical label text development, initial supplies, and resupply strategy. o Update packaging and supply forecasts to ensure that actual patient demand aligns with supply projections and study assumptions. o Provide input and strategy for the set-up of IRT medication management modules. Perform UAT and manage IRT milestones and supply strategy throughout the clinical study life cycle.o Proactively identify risks to the clinical supply chain, provide analysis of risk, and recommend actionable mitigation plans.o Track and manage clinical supply operational budgets on behalf of clients.

Tel-Aviv, Il

Manage activities across CMC, Clinical Operations, Quality, and Regulatory to ensure clinical supply delivery timelines are aligned with key performance indicators, project deliverables, and trial timelines.Develop long-term supply strategies and manage the supply chain for global trials for small and large molecules across all clinical phases (I – IV).Manage distribution of final patient kits, monitor depot and site inventory levels, ensure initial patient projections and demand forecasts are aligned with actuals, and update packaging and supply forecast as required throughout the course of global clinical trials.

Brentford, Middlesex, Gb

Coordinate with Clinical & Regulatory groups to develop and maintain clinical supply by forecasting drug requirements. Develop dynamic patient pack and distribution plans at the study level based on clinical protocol and projected/actual patient enrollment. Agreeing global/regional requirements for clinical supplies.Plan, organize, control, and execute pack plans for materials to ensure patient focused commitment dates, high quality material planning inputs, and minimization of expedite charges resulting in the efficient use of labor, equipment, and inventory resources.

Brentford, Middlesex, Gb

Project manager for biochemical and cellular HTS assay campaigns. Facilitate assay transfers from internal development group and global external collaborators to screening group. Provide organizational and scientific leadership in the development and standardization of HTS screening assays and methods. Manage and track reagent and assay validation, primary screening phase, and XC50 screening to delivery of lead novel chemical series to global R&D partners. Develop and implement cellular, biochemical, and biophysical assays to further elucidate compound characterization and progress tractable hits through lead optimization. Perform weekly SAR assays in cellular and biochemical formats to provide chemists with structure-activity data to direct compound series progression from lead to candidate.

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

M.S., Biological Sciences And Biotechnology

B.S., Biology, Chemistry