R&d Global Project Manager

**Title**:
R&D Global Project Manager

**Company**:
Ipsen Pharma (SAS)

All of Ipsen’s assets are managed through a fully integrated asset team focused on maximizing patient value and the success of the asset in all aspects across its entire lifecycle.

The main mission of the Global Project Manager CMC (GPM) is to work in collaboration with the Asset Operation Lead (AOL), the CMC functional lead and the Asset Team (AT) members to develop, implement and manage strategic project and cmc subteam plans (as required by the asset team) and its associated budget (internal and external costs), to ensure that a consistent project risk management methodology is applied at the asset team and subteam level to proactively identify project risks and opportunities together with contingencies and to use learning and experience from current, previous projects, competitor benchmarking and from the network of Global Project Managers to support successful delivery (knowledge management).

A cmc sub-team is defined as a cross functional team accountable for concrete deliverables such as IMP and NDA or could be all activities related to the development of the asset in one indication / population (clinical development, CMC, regulatory, industrial and commercial)

He / she closely partners with the Asset Operation Lead (AOL) and cmc functional lead to serve as the central points of contact for the team / subteam members to enable the successful operational delivery of the project. When necessary, serve as deputy for AOL / cmc lead

He / she is the right hand of the AOL ensuring that cmc subteam serves the asset and operationalizein alignment with asset strategy and being able to cover AOL at the asset team level. He / she masters all the interdependencies between workstreams as well as the risk mitigation actions.

**Core Competencies**

**Responsibilities**

**Project Management**
- Leads generation of cmc subteam and project plans (eg: one plan containing all activities related to the development of the asset in one indication / population including, but not limited to, clinical development, CMC, regulatory and commercial) and aligns with the Global Asset Plan
- Partners with cmc lead and functional reps to ‘pressure-test’ assumptions and function planning to support the cmc subteam and project plans.
- Defines the interdependent subteam deliverables aligned with Global Asset Plan and ensures that quality, risk, cost, time are managed to enable delivery of project milestones and objectives on time and on budget.
- Validate the technical integrity of the cmc subteam and project plans ensuring that the technical data is reviewed and discussed at the workstream team meeting for appropriate decision recommendation to the Asset Teams on follow-up actions
- Drives with the cmc lead execution of the workstream plan and associated deliverables across functions to achieve the overall asset objectives.
- Closely and proactively monitors the execution of cmc subteam and project plans, measures result, communicates deviations/discrepancies to AOL, specifically focusing on:

- Deliverables on time / at risk
- Key milestones
- Budget / Resource
- Contingencies
- Resource constraints if required
- Issues

and proposes deviation correction to ensure successful workstream delivery
- Updates cmc subteam and project plans (timelines, budgets and milestones) regularly in the appropriate tool to ensure data for metrics reporting is accurate
- Ensures decisions and actions at the subteam level are tracked in due time
- Performs oversight of all activities and associated deliverables under the accountability of the subteams.
- Must be able to demonstrate an appropriate level of technical understanding of the various functions to ensure effective cross-functional communication (see technical competencies section)
- Proactively manages changes, anticipating potential problems (potential resource bottlenecks, risks to critical milestones, inefficient processes) and proactively develops and seeks approval for risk mitigation plans. Takes accountability for ensuring any agreed changes are implemented as required
- Is responsible for supporting functional leads in vendor selection and management
- Comply with all laws, regulations and policies that govern the conduct of IPSEN activities. Always follow IPSEN policies, procedures and processes (including R&D Op ones)
- Actively adhere to a Quality Management System (QMS) that supports GxPs and regulatory requirements and satisfies all internal quality and external regulatory authority expectations.
- Always acts following One Ipsen Way of Being

**Leadership**
- Serves as the central operational point of contact for cmc, project subteams and Asset team members
- Creates a climate that fosters personal investment and excellence and nurtures commitment to common goals
- Facilitates the process for evaluation of alternative development options at the cmc and project subteam levels to deliver programs.
- F