Johnson & Johnson Careers

Project Leader, Innovative Medicines Initiative (IMI) Integrated Research Platform (IRP)

Beerse, Belgium
R&D


Job Description

Requisition ID: 1805699890

The Innovative Medicines Initiative (IMI) Integrated Research Platform (IRP) Project is a public-private partnership project that is co-funded by the European Community (IMI) and a consortium of 13 Pharma companies (EFPIA) and IMI2 JU Associated Partners. Public partners to the consortium are being identified.  The overall goal of the project is to transform experimental clinical development concepts into a reusable and endorsed methodology for Platform Trials that is broadly accepted for application in new drug development. It will create best practices, tools and guidelines for establishing multi-company platform trials by leveraging, extending and improving concepts from previous pioneering multi-company platform trials to new disease areas.

The proposal is divided into (i) a set of common foundational elements applicable to all disease areas, (ii) clinical networks and networks of patient-level data and (iii) disease-specific integrated research platforms in several disease areas (depression, tuberculosis, non-alcoholic steatohepatitis, and neurofibromatosis). Execution of the platform trials is currently out of scope. The full workplan and necessary collaboration, funding and consortium agreements must be developed in 2019.

Reporting to the VP Clinical Operations, Johnson & Johnson, the IMI IRP Project lead for this PPP will assume day-to-day responsibility for coordinating the setup of the IRP Project and will provide leadership to the development of the full workplan in collaboration with the EFPIA and Public partners (due date May 2019). Following the official approval and kick off-of the project (expected in Nov 2019), the candidate will be accountable for the execution of the project both in terms of time, deliverables and budget.
 
During the duration of the Project, se/she will be delegated to interact intensively with many subject matter experts and organizational representatives within Janssen, a dozen other Pharma companies, and a yet unknown number of public academic and other public partners. Project management support is foreseen from PMO.

In addition to excellent communication and negotiation skills, important attributes of the candidate include proactivity and initiative, organizational savvy and courage, and goal orientation. Sufficient understanding of the (process of) design and execution of clinical trials is essential.
 
In terms of background, experience in either Regulatory, Biostatistics, Clinical Operations or Clinical Development is a necessity.

 
Major Duties & Responsibilities
 
·   Accountable for the design, development of the framework and the full work plan for all Work Packages defined for the project.
·   Accountable for the execution of the Project in terms of time, deliverables and budget.
·   Provide insights on best practices and methodologies to ensure the re-use ability of the frameworks to execute platform trials.
·   Drive engagement across Janssen subject matter experts to gain insights, challenge solutions, and ensure frameworks can be operationalized for execution of platform studies within J&J.
·   Support governance and communication plans to ensure collaboration across public-private partnership project and the funding partner European Community (IMI)
·   Ensure lessons learned is communicated and implemented within the Janssen/J&J organization so ensure we obtain the value from the Project within our new way of working
·  Develop strategic partnerships internally within Janssen and across the public-private partners to build relationships that drive collaboration for industry wide impact
·  Lead the communication of the IRP project  
·  Conduct regular status updates and reviews with executive sponsors and governance, facilitating discussions to identify and resolve issues, and obtain alignment on required decisions Support business development partnering activities & potential external co-development partners
·  Establish and oversee external partnerships with partner institutions and enable application of novel approaches to the use of platform studies. Develop insights on best practices and methodologies to ensure the re-use ability of the frameworks to execute platform trials.
·  Drive engagement across Janssen subject matter experts to gain insights, challenge solutions, and ensure frameworks can be operationalized for execution of platform studies within J&J.
·  Support governance and communication plans to ensure collaboration across public-private partnership project and the funding partner European Community (IMI)
·  Ensure lessons learned is communicated and implemented within the Janssen/J&J organization so ensure we obtain the value from the Project within our new way of working
·  Develop strategic partnerships internally within Janssen and across the public-private partners to build relationships that drive collaboration for industry wide impact
·  Lead the communication of the IRP project  
·  Conduct regular status updates and reviews with executive sponsors and governance, facilitating discussions to identify and resolve issues, and obtain alignment on required decisions Support business development partnering activities & potential external co-development partners
·  Establish and oversee external partnerships with partner institutions and enable application of novel approaches to the use of platform studies


Qualifications
Required Knowledge, Skills and Abilities:
 
 
Education:
  • Advanced degree in a scientific discipline is preferred     
 
General: 
  • 10-15 years of experience in (preferable clinical) drug development within the pharmaceutical industry
  • Broad knowledge of clinical development with expertise in one or more of the following: Regulatory, Biostatistics, Clinical Operations or Clinical Development
  • Demonstrated experience in implementing and managing complex transformational projects
  • Excels in partnering and collaborating with multi-cultural, interdisciplinary teams
  • Strong interpersonal skills including strong negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity.
  • Organizational savvy 
 
Leadership competencies
  • Proactively seek, evaluate and integrate input from a variety of private and public stakeholders
  • Manage towards achieving the overall PPP objectives while balancing these with Janssens’ interests
  • Inspire private and public consortium to collaborate and push boundaries in the design of innovative solutions to complex problems
  • Drive and oversee efforts to achieve project milestones no later than on non-negotiable due dates
  • Ability to evaluate innovative ideas and align their value to the needs and requirements of all partners
  • Ability to anticipate potential risks and issues that may impede the initiative and determine mitigating actions 


Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
1805699890