Senior Director CMC Portfolio Lead Mammalian Projects Cluster

The CMC Cycle 2 Portfolio Lead is accountable for the CMC project activities of mammalian products of Sanofi’s R&D pipeline in Cycle 2 development phase, i.e. from Phase 2 (Proof Of Mechanism or Proof Of Concept, depending on project strategy and potential for acceleration) to start of Phase 3 clinical development stage. This role is accountable for leading a sub-group of CMC Project Leaders (PL) within the Mammalian Projects Cluster, including both solid line reporting CMC Project Leaders and dotted line reporting CMC Project Leaders from the CMC Platforms. Key Responsibilities: Leads CMC Project Leaders in preparation for key meetings (i.e. CMC Stage Gates and Technical Reviews, Portfolio reviews, CMC Boards, DWG reviews, SPPC Sourcing) while overseeing the scientific relevance and the consistency with project strategy of the CMC plans and the CMC risks assessment with mitigation plans. This includes in particular: Direct management of a small team of project leaders/managers with direct impact on 50 to >500 M€ projects CMC activities and deliverables (internal and external costs) Oversight in CMC and subteams of approximately up to 600 FTEs transversally. Supports CMC PL to provide R&D governance bodies with evaluation of CMC activities in terms of consistency with the strategy of the project, risks and opportunities, and budget. Delivers CMC expertise with communication adapted to non CMC experts Gives input on project strategy, operational plan, scenario planning beyond CMC perimeter, in order to contribute to the overall project assessment. Constructively challenges CMC plans, encouraging calculated risks, assessing potential for acceleration and alignment of resources with project priority. Liaises with IA partners and CMC functions (e.g. MamP, BioA, BDPD&M) to prepare aligned R&D/IA sourcing recommendations for phase 3 and launch, for endorsement by IA governance bodies. Liaises as needed with Development TA heads / Global Project Heads to ensure that CMC risks evaluation and mitigation plans are well understood. Ensures appropriate cascading of project information to functions in order to have rationale of R&D governance body decisions well understood. Supports CMC PL in the evaluation of CMC risks and appropriate escalation to Senior Management (e.g. Cluster Head & Global Management as needed). Leads and coaches Cycle 2 projects CMC PLs, performs performance reviews of both direct reports and functionally reporting CMC PLs according to Sanofi guidelines Contributes to talent development and adaptation of skills and capabilities to the portfolio needs and the quality standard requirements (develops scientific and leadership skills, ensures cross fertilization within sub-cluster and across clusters and with the functions (Mammalian Platform, BioAnalytics, BDPD&M, CMC Dossiers, SQO, MED, MSAT, etc.) Fosters application of best practices in order to increase efficiency, contributes to R&D initiatives for operational effectiveness and encourages transparency and willingness to improve with the right level of risks. Contributes to adapt the Cycle 2 Development operating model by providing new ideas and participating to initiatives Contributes to recruitment and nomination of CMC Cycle 2 portfolio CMC Project Leaders as needed. Basic Qualifications: PhD in one of the areas of biopharmaceutical drug development (e.g. pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry) with a minimum of 12 years of experience in the pharmaceutical development industry or a Master's degree with a minimum of 16 years of experience in the pharmaceutical development industry A minimum of 7 years of experience managing direct reports and/or project teams with ability to mentor talent Strong expertise in Biologics CMC area, with proven experience in at least 2 scientific areas, e.g., analytics, process dev., regulatory CMC, manufacturing, etc. Comprehensive scientific background in biotechnology and/or protein science Experience and understanding of current Pharmaceutical environment including the economic and regulatory challenges Experience in BLA submission Confirmed experience in project management, in working in project team and in complex environment (e.g., transversal assignments across different sites) Fluent in English Strong leadership capabilities, strong team spirit and capacity to coordinate several activities and stakeholders Excellent communication skills Experience in leading international and/or multi-cultural teams Influencing and negotiation skills to build solutions and partnership Ability to interact effectively with executive/senior management and external bodies (e.g., auditors, health authorities, etc.) Preferred Qualifications: Experience in CMC Development Ability to take responsibility for decisions and accountable for results Ability to challenge status quo and to propose alternatives At Sanofi R&D North America, we deliver meaningful solutions for patients. 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