Senior Product Development Project Manager

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We are looking for a Senior Product Development Project Manager to join our Montpellier facility to participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health. As a Senior PD project manager, you will have overall responsibility for the planning, coordination and timely execution of assigned product development projects in collaboration with cross-functional teams.

Responsibilities 

In this role, you will ensure the appropriate coordination of multiple functions, i.e. formulation, regulatory affairs, clinical, portfolio management, alliance management, preclinical safety, etc., to effectively execute drug development.  You will draw up binding project development plans based on a pre-approved project schedule matrix and be responsible for ensuring each project remains on schedule.

  • Determine the overall strategy and process for the execution of drug development projects in collaboration with internal teams (formulation, analytical, process, regulatory affairs, toxicology, clinical, portfolio management) and alliance partners (if applicable)
  • Develop operational plans together with internal teams and alliance partners (if applicable), including:
    • development strategy
    • realistic timelines
    • budget planning
    • resource identification and planning
    • risk assessment
    • contingency planning
  • Ensure smooth progress of projects in clinical development towards product filing, coordinating the necessary regulatory and quality documentation
  • Monitor and track projects against approved timelines and milestones, and ensure adherence to agreed-upon objectives and deliverables
  • Prepare and lead regular updates and planning meetings with internal teams and alliance partners
  • Report project progress in a relevant format
  • Identify bottlenecks, surface issues, and proactively drive for their resolution
  • Lead risk assessment, contingency planning efforts and ad-hoc cross-functional task forces as needed for issue resolution
  • Provide accurate forecasting, tracking and adherence to program budget
  • Ensure that all project data  and project plan are accurate, up to date, and accessible on the server/share point
  • Represent the development project team on assigned transversal project teams and contribute to the development of overall strategies
  • Support Business Development and Alliance Management, by communicating

appropriate update and relevant information on project progress to interact with existing or new partners

  • Lead interactions with CMOs in order to ensure the delivery of results and batches within time, budget and quality – Assess CMO performance and proactively ensure Quality, service, and cost objectives are achieved
  • Consolidate and track project termination plans
  • As an integral member of the Project Management team, you will participate in:
    • developing metrics / KPIs
    • evaluating projects against metrics
    • proposing improvements to processes
    • performing lesson learnt survey and develop post-closure report

Requirements

  • 8+ years of relevant work experience in a pharmaceutical and/or biotechnology company in a GMP environment
  • Experience in the full drug development cycle from proof of concept to late development stages
  • Experienced project leader, with experience from beginning to the end of project cycle for several projects
  • Expert knowledge of drug development processes and regulations
  • PharmD or PhD in pharmaceutical science ideally with an industrial pharmaceutical focus
  • Experience in international and multidisciplinary teams

 Knowledge, skills and abilities

  • Project management skills:
    • Ability to accurately estimate time for specific tasks
    • Ability to plan sequential and / or concurrent activities
    • Ability to develop and manage budgets
    • Ability to determine priorities within project plan
    • Ability to work on several tasks simultaneously
    • Ability to coordinate a multidisciplinary team
  • Strong interpersonal and communication skills for:
    • Managing relationships and communication exchanges internally and with Alliance Management
    • Managing interactions with CMOs for timely delivery of regulatory/clinical batches and analytical package
    • Effectively preparing and leading meetings internally and with third-parties in English
    • Effective international collaboration

Communication

  • Fluency in oral and written English with a very good working knowledge of French
  • Demonstrated ability and conceptual knowledge to produce high quality written reports and other documents, that effectively communicate in a clear, organized and concise manner to senior management and others for decision making

Soft skills

  • Effective functioning in a rapidly changing environment and adherence to the values, principles and mission of the company
  • Ability to deal effectively with demanding and stressful situations
  • Proficiency in self-learning new skills, tools and software
  • Desire to solve complex problems
  • Consistency, precision, perseverance, listening skills
  • Openness and ability to adapt to changing situations
  • Strong team spirit and open sharing of all the information necessary to successfully achieve overall work goals
  • Desire to continuously improve and progress
  • Strong work ethic

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