Directeur Asset Operations Lead

Summary / purpose of the position

Ipsen’s goal is to bring the full potential of our innovative medicines to patients by building and delivering a high-value, sustainable pipeline. This ambition is facilitated by the transformation of our operating model, through implementation of the asset centric model (ACM) 2.0, to create an even higher performing organization, with the goal of leaving no patient behind. The AOL is a key element of the asset centric model, as the single point of accountability for operational execution of asset strategy.

The main mission of the AOL is to implement the asset roadmap by driving the cross functional asset team and to be the right hand to the Asset Lead across the product lifecycle. The AOL may support one or multiple assets.

The AOL is responsible for the execution of the asset strategy, tactics and plans endorsed by the governance bodies, to ensure the delivery of commercially viable products.

He/she ensures that all steps of the development plan are anticipated, planned, coordinated and followed-up to deliver in the most efficient process.

He/she monitors and tracks expenditure against budgets and supports resource management against agreed strategic objectives for the program.

He/she is responsible for ensuring coherent and consistent communication between project functions and for ensuring key issues are reported to the executives in due time and to work with senior team members on issue resolution.

When required by the asset team structure, he/she will be supported by Global Project Managers.

Main responsibilities / job expectations

Program Operational Leadership

• Work in partnership with the Asset Lead, Function reps and Franchise Heads to create and maintain asset roadmap from overall asset strategy (including LCM and partner activities) detailing objectives, KPIs and PoS.
• Create a climate that fosters personal investment and excellence and nurtures commitment to common goals.
• Facilitate the process for evaluation of alternative development options to deliver programs.
• Facilitate win/win solutions for program/team conflicts with big picture in mind. Promote ideas persuasively and build on the ideas of others.

Program Operational Management

• Create and maintain global Integrated Project Plan across functional lines, capturing interdependencies between all functions and deliverables, to be updated at least once a month, highlighting critical path, and upcoming deliverables.
• Drive cross functional asset team to prepare Target Product Profiles to deliver differentiated products under the scientific, medical and commercial leadership of the Asset Lead.
• Create and maintain the Live Asset Assumptions slide as a key input to the project plan, scenario planning, risk analysis, budget and valuation.
• Partner with functional leads to pressure-test assumptions and integrate function planning across development into the overall program plan, (e.g. CMC, Regulatory, Clinical, Biostatistics, Technical Operations, Commercial, Medical Affairs, Safety, etc.).
• Define the interdependent deliverables and ensure that quality, risk, cost, and time are managed within the overall approved plan to drive delivery of asset roadmap milestones and objectives on time and on budget.
• Ensure that the plan is realistic for all R&D functions as well as for Tech Ops, BD, Alliance, and Commercial.
• Validate the technical integrity of the project team plan ensuring that the technical data is reviewed and discussed at the project team meeting for appropriate decision making on follow-up actions.
• Implement and drive cross-functional monthly asset operation meeting with all function leads to closely and proactively monitor the execution of plans, measures result, update and align key planning assumptions with corresponding timing, risks, resources and budget impacts and communicate deviations/discrepancies to Asset Team, specifically focusing on and correct deviation to ensure successful project delivery:

1. Deliverables on time / at risk

2. Key milestones

3. Budget / Resource Contingencies

4. Resource constraints if required.

5. Issues

• Update full-scale project plans, timelines, budgets and milestones regularly in the appropriate tool to ensure data for metrics reporting is accurate.
• Drive milestone decision point planning and associated deliverables across functions to achieve the overall program objectives.
• Clearly define the critical path and generate clear decision criteria for the project.
• Serve as the central operational point of contact for team members.
• Ensure decisions and actions are tracked in due time.
• Perform oversight of all program activities related to the development program including, but not limited to, clinical operations, CMC, regulatory and commercial etc.
• Demonstrate an appropriate level of technical understanding of the various functions to ensure effective cross-functional communication.
• Responsible for ensuring that all the projects’ functions and disciplines deliver with precise execution, quality, in time and within budgets.
• Proactively manage changes in project scope, anticipating potential problems (potential resource bottlenecks, risks to critical milestones, inefficient processes and resource variance) and proactively develops and seeks approval for risk mitigation plans.
• Comply with all laws, regulations and policies that govern the conduct of IPSEN activities. Always follow IPSEN policies, procedures and processes (including Global R&D Operation ones, such as governance process).
• Actively adhere to a Quality Management System (QMS) that supports GxPs and Regulatory requirements and satisfy all internal quality and external regulatory authority expectations.
• Ensure project / workstream deliverables are managed to enable completion on time and according to required scope and budget, while applying the best practices and tools of an efficient PMO.

Risk Management

• Apply a comprehensive risk management methodology that proactively identifies program risks and opportunities together with developing and delivering appropriate contingencies and/or corrective actions to support the team in development of solutions to project conflicts and issues.
• Apply a deep understanding of risk management methodology in using risk to communicate effectively with Governance bodies and underpin project strategy and delivery.
• Provide asset risk map to the Risk Corporate group on an annual basis.

Budget and Resource Management

• Partner with the Asset Lead and function representatives on the asset team to ensure that budget, resource management and project controls are established.
• Manage project budget and resource plan in partnership with the Asset Lead, Finance lead, function heads and function representatives on the team.
• Accountable and responsible to lead budget sessions at intervals that align with Finance budget/forecast calendar delivering and to translate board decisions to team and project budgets.
• Ensure actuals are properly recorded and coded to the project.
• Ensure all supportive materials and data are provided for tax credit requests on due time.
• Support workstream leader to ensure resource, cost and schedule are up to date to enable long term planning.

Knowledge Management

• Perform “lessons learned” workshops to identify cross-functional learning to be applied across the portfolio on an as-needed basis (at minimum at stage / gate).
• Develop a mindset around benchmarking versus competitors and use this approach to challenge plans and decisions with the team.
• Apply competitor benchmarking to pressure test scenarios when interacting with governance bodies.

Communication and Reporting

• Effectively communicates project expectations to team members, senior leaders and the broader organization. Escalates issues to team members and stakeholders in a timely fashion.
• Define governance strategy, streamline governance process and decision making at the Asset level, create and communicate governance material with all involved stakeholders and the PFM team.
• Prepares and manages governance interactions in partnership with the Asset Lead.
• Define and implement a communication strategy / plan for the project that supports the most effective team empowerment and progress.
• Define and report metrics to measure project performance, while executing the plan.

Knowledge, abilities & experience

Education / Certifications:

Bachelor’s degree in science. Certification in Project Management, MBA and /or PhD is a plus.

Experience

This role requires full understanding of drug development business processes.

10-15+ years’ experience in the Pharmaceutical / Biotech industry and / with experience and understanding of the drug development process, clinical development and project management.

Languages:

English, French is a plus.

Travel:

The position is a cross-functional support role and frequent travel will be required: +/- 20% Domestic and International may be required.

Key Technical Competencies Required

• Experience working within 1-2 functional area such as clinical, preclinical, CMC or regulatory affairs is required. US / EU pharmaceutical regulations experience is a must.
• Proactive and agile to work in a fast-paced environment. The successful candidate will have sound judgment, problem solving, leadership skills and emotional intelligence to lead cross-functionally and identify solutions. Candidates should be able to demonstrate ability to work collaboratively with cross functional team members.
• Excellent communication (written and verbal) and interpersonal skills. Strong financial acumen to develop/manage program budgets.
• Strong experience in facilitating project team meetings, cross-functional communication, decision making and ensuring alignment with internal/external stakeholders.
• Experience at working both independently and in a team-oriented environment with minimal supervision.
• Demonstrated ability to effectively prioritize, multitask and execute tasks in a fast-paced environment is crucial.
• Important sense of urgency and ability to pace the team work to complete milestone achievement in highly competitive environment.
• Strong customer and patient focus.

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