Sanofi Group Development, Life Cycle Management Global Project Head in Swiftwater, Pennsylvania
The Development GPH is accountable for developing & executing the integrated strategy and development plan for their respective project. The GPH drives execution of the development plan by leading the Global Project Team and acts as a leader/mentor/coach for the team members.
This role will have approximately 25-30% global travel.
The scope of Development GPH project responsibilities extend longitudinally from M2 stage gate through product licensure in primary countries defined within the TPP. As such, the GPH also co-leads the Common Technical Document Task Force in partnership with the Global Regulatory Team Leader and therefore, ensures preparation for product launch well in advance of target launch date. (TBD/TBV)
The GPH is accountable for structuring the Global Project Team in cooperation with R&D and non R&D function heads and, with direct support of global project team members, ensures the execution of the project within timelines & budget. The GPH is expected to drive projects forward, through stage gate milestones, according to aggressive but realistic timelines.
The GPH sets expectations of each global project team member at the beginning of the year, contributes to mid-year feedback and end of the year assessment. The GPH is also responsible for management of project risk which includes communication of impactful risks through appropriate governance committees and seeking feedback on risk management from strategic forums.
The GPH develops effective working relationships with significant influencers (i.e. opinion leaders) at multiple levels (internally and externally) and ensures alignment and coordination with major stakeholders across the company including external partners.
As member of the Franchise Steering Team, the GPH develops a unified R&D vision and strategic roadmap covering the entire R&D value chain for project development (M2 – licensure). The GPH is an ambassador of the project, is the main NV project point of contact for Sanofi Pasteur globally.
NV Project Organization / Structure
The Development GPH:
Reports to the Head of the NV Development Portfolio and leads the global project team for a given NV program.
Approves GPTM assignments to the team, helps set yearly expectations for GPT Members, provides formal mid-year/year-end feedback and informal feedback throughout the year.
Is a member of the Franchise Steering Team.
Is co-lead with the GRTL for the CTD Task Force starting at least 18 months prior to first license submission and extending through licensure in primary countries as defined by the TPP
Is a member of the Brand Team from inception of the brand team to completion of major development initiatives leading to key license variations.
Project Strategy and Execution
The GPH owns the overall NV project strategy and plan in alignment with F&PS. For projects with external partners the incumbent is accountable for building and maintaining aligned strategy with the partner(s).
Ensures the implementation and the update of the integrated development plan along with the team.
Ensures the development and maintenance of the TVP and TPP by F&PS with inputs from GPT.
Translates the TPP into scope and objectives of the NV project.
Ensures initial (pre-Brand Team) activities related to launch preparedness are well defined and executed.
Ensures the alignment of IEGP, iSCP and the strategic functional plans (e.g. CDP, TSD, and GRPS) with TPP and TVP endorsed by TARC and PSC.
Ensures that the right interactions with health authorities are in place for strategy alignment and readjustment when needed.
Ensures that IP strategy and integrated scientific communication plan are well captured in the global plan.
Ensures that the project communication and publication plans are aligned with overall project strategies and are up to date.
The GPH is accountable for overall project execution: The incumbent drives execution via global project team members and sub-teams with responsibility for the operational implementation of the project strategy though functional detailed plans and activities.
Aims to deliver expected results on-time, within approved budget, in accordance with the project priority, strategy & risk-management plans with the support of robust project management processes from R&D operational functions
Ensures that risk-mitigation plans are established, escalated and validated by relevant internal governance bodies (i.e. TARC, PSC, IDC, DWG and RWG and previously by any non R&D gov).
Supervises project activities and resolve resource utilization issues with TMs and functional heads in order to meet project objectives (strategic plan and timelines).
Makes effective decisions within the decision rights of GPT and using appropriate committees for feedback and governance. The GPH leads and prepares with TM Stage Gate reviews and Project Committee reviews (e.g., xSFs, TARC, PSC, DWG, and IDCC + any non R&D key committees like VIA & RA).
Works with the Functions and other GPHs to find alternative ways, simplification and operational innovations out of the norm in order to accelerate timelines, and/or to resolve setbacks of getting the right execution.
Maintains mechanisms to capture and share knowledge, leverage learning and implement improvements within the project team.
The GPH, as ambassador of the project, leverages the communication of the NV Project to all relevant entities (internally & externally). The incumbent communicates in timely and effective manner with team, functional platforms and management, especially on significant change/events.
Ensures effective communication and Alliance Management with third parties including NGOs ( N on- G overnment O rganizations), partner Companies, academic groups and joint ventures.
In case of grant preparation/external funding needs, GPH can request immediate resources from relevant functions.
Role on the Global Project Team
The GPH ensures that expectations to each functional representative are clear
creates an inclusive space for each project members
ensures external feedback/challenge on the project strategy
contributes actively to the development of project team members
is decisive, making final decision when there is no alignment in GPT
encourages and promotes visibility of project team members
Scope and dimensions
GPH reports to the Head of the NV Development and LCM Portfolio Strategy GPH is a member of RDSLT & GLN, FST and Global Brand Team
GPH participates in other key meetings (i.e. TARC, PSC, VIA Investment Committee + RA committee ?) on case-by-case basis
GPH is fully accountable for the NV project.
Transversal, international and cross-functional team management within R&D and beyond (VIA, Franchise, IP, RA, IA , Med, FP&Setc.)
NV projects can require resourcing over a wide range (tens to hundreds of employees) depending on stage and complexity of the program. The project team operates in a cooperative way, without formal hierarchy, under the leadership of the GPH. Development projects may last from approximately 4 to 12 years depending on the stage of entry and can represent a wide range of annual sales (e.g., approximately 100 M to over 1 B Euro).
Education and experience
Ideally, Ph.D. (in a science field), MD or Pharm D. with at least 7 years of experience in vaccine development experience or other disciplines such as industrial operations, regulatory affairs, marketing, research, and quality control/assurance.
Or B.S., M.S. degree or MBA with over 10 years relevant experience (These represent guidelines on the GPH profile, which may vary based on project stage, i.e. pre-dev, early-dev, late dev, LCM).
Preferably experience in program management, people management and understanding of basic business principles.
Experience in or demonstrated evidence for the capacity to lead and manage groups of professionals
Experience working in the pharmaceutical or biotechnology industry.
Strong leadership skills to manage international, cross-functional teams of highly skilled professionals
Good networking ability in cross-cultural environment.
Strong interpersonal, communication, presentation, decision-making and negotiation skills across all levels of the organization
Understanding of global vaccine development activities along the whole value chain from research up to market access. Skilled in project and/or budget/resource management.
Strategic thinking in combination with understanding of scientific and business aspects of biopharmaceutical product development.
Performance oriented with ability to work along agreed timelines and a focus on strategy and execution.
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.
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