Senior Director, Head of Rare Disease Asset Operations jobs in United States
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Ipsen · 4 days ago

Senior Director, Head of Rare Disease Asset Operations

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. They are seeking a Senior Director, Head of Rare Disease Asset Operations to implement the asset roadmap and drive the cross-functional asset team to ensure the delivery of commercially viable products.

BiotechnologyPharmaceuticalProduct Research
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H1B Sponsor Likelynote

Responsibilities

Work in partnership with the Asset Lead and Franchise Heads to develop and implement overall asset strategy to deliver sustainable product growth in the 5-10-year timeframe
Drive development of the global program level goals that contribute to the overall objectives for the IPSEN portfolio
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
Align Integrated Development Plan across functional lines
Drive cross functional asset team to prepare Target Product Profiles and global plans to deliver differentiated products under the scientific, medical and commercial leadership of the Asset Lead
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 ensures that quality, risk, cost, 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
Closely and proactively monitors the execution of plans, measures result, communicates deviations/discrepancies to Asset Team, specifically focusing on: Deliverables on time / at risk
Key milestones
Budget / Resource
Contingencies
Resource constraints if required
Issues and correct deviation to ensure successful project delivery
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 defines the critical path and generates 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
Accountable for ensuring any agreed changes are implemented as required
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 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
Always act following One Ipsen Way of Being
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
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
Perform “lessons learned workshops” to identify cross functional learnings 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
Effectively communicates project expectations to team members, senior leaders and the broader organization. Escalates issues to team members and stakeholders in a timely fashion
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’s performance, while executing the plan

Qualification

Drug development processPharmaceutical regulationsProject managementBudget managementCross-functional leadershipMultitaskingAgilityFrench languageEmotional intelligenceCommunication skillsInterpersonal skillsProblem solvingCustomer focusTeam collaboration

Required

Bachelor's Degree in Science
10-15+ years' experience in the Pharmaceutical / Biotech industry and / with experience and understanding of the drug development process, clinical development and project management
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
Sound judgment, problem solving, leadership skills and emotional intelligence to lead cross-functionally and identify solutions
Ability to work collaboratively with cross-functional team members
Excellent communication 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
Important sense of urgency and ability to pace the team's work to achieve milestone achievement in highly competitive environment
Strong customer and patient focus
Written: Excellent
Verbal: Excellent
Interpersonal: Excellent

Preferred

Certification in Project Management, MBA and /or PhD is a plus
French is a plus

Company

Ipsen is a global specialty-driven biopharmaceutical company focused on innovation and specialty care.

H1B Sponsorship

Ipsen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$574.72M
2025-03-19Post Ipo Debt· $545.59M
2017-11-20Post Ipo Equity· $29.13M
2005-12-16IPO

Leadership Team

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David Loew
Chief Executive Officer
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Josep Catlla
Executive Vice President & Chief Corporate Affairs Officer at Ipsen
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Company data provided by crunchbase