Director, Due Diligence and Integration

Ipsen • Cambridge, MA

9d

About The Position

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 operationalize in 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.

Requirements

• This is a role that requires full understanding of drug development business processes.
• Bachelor’s Degree in Science.
• Certification in Project Management.
• 5-10+ years’ experience in the Pharmaceutical / Biotech industry.
• Understanding / experience working within the development of manufacturing, pharmaceutical formulations across different modalities
• Experience in device development is a must
• Proactive and agile to work (prioritization and multitasking) in a fast-paced environment.
• Problem solving and decision-making skills.
• Demonstrated ability to drive initiatives, solve issues (conflict management and facilitation skills), anticipate problems and achieve objectives, while keeping an eye on the big picture.
• Excellent communication and interpersonal skills.
• Networking and stakeholder management skills.
• Ability to establish and maintain effective working relationships with R&D departments, Franchise, Industrial, Medical Affairs and external customers/contractors
• Strong experience in facilitating/driving project team meetings and decision making while ensuring alignment with internal/external stakeholders.
• Show courage.
• Work constructively under pressure.
• Good clarity of judgment and effectiveness at implementation of solutions
• Highly competent in use of Microsoft Office, Microsoft Project and other PM appropriate tools.

Nice To Haves

• PhD or Pharma D is a plus.
• Knowledge in Phase III, filing and launch phases would be considered beneficial.

Responsibilities

• 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.
• Ensure 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. 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.
• Facilitate win/win solutions for project / team conflicts with big picture in mind.
• Promote ideas persuasively and build on the ideas of others
• Plan and supervise the development of very complex application systems (e.g. devices and combination products) at third-party companies as well as independent evaluation and improvement of technical solution approaches
• Applies a consistent risk management methodology that proactively identifies cmc and project subteam risks and opportunities together with developing and delivering appropriate contingencies and/or corrective actions to support the workstreams team in development of solutions to project conflicts and issues
• Applies a deep understanding of risk management methodology in using risk to communicate effectively to the Asset Team and underpin workstream strategy and delivery.
• Manages project/cmc subteam budget and resource plan in partnership with the Asset Operation Lead (AOL), cmc functional lead, Finance lead and function heads and function representatives on the team
• Support AOL 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 asset
• Ensure all supportive materials and data are provided for tax credit requests on due time
• Support cmc functional lead to ensure resource, cost and schedule are up to date to enable long term planning
• Performs “lessons learned workshops” to identify cmc and project subteam learnings to be applied across the asset team on an as-needed basis (at minimum at stage / gate)
• Develops a mindset around benchmarking versus competitors and use this approach to challenge cmc and project subteam plans and decisions with the team
• Effectively communicates project expectations to cmc and project subteam members. Escalates issues to AOL and Asset team members in a timely fashion.
• Prepares and manages governance interactions in partnership with the Asset Operation Lead (AOL). Nd cmc functional lead
• Define and implement a communication plan that supports the most effective workstream team empowerment and progress
• Define and report the metrics to measure project’s performance, while executing the plan

Benefits

• comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts
• Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level