Janssen Research & Development, LLC, a member the Johnson & Johnson Family of Companies is recruiting for a Global Operations Lead – IIS Collaborative to be located in Titusville, NJ or any other Janssen Research & Development or Janssen Affiliate location Worldwide.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Global Operations Lead – IIS Collaborative will have primary global accountability for GCDO-MAO for the IIS and collaborative study global framework (policy, processes, systems, vendors) and oversee harmonized global implementation of the framework due to a differentiated capability for GCDO-MAO-managed Investigator Initiated Studies (IIS) and collaborative studies arising from increasing demand, strategic partnerships, evolving space and compliance risk (e.g. FCPA, GCP). This individual will act as the single point of accountability within GCDO-MAO at the global IIS and collaborative studies level, and will have strong leadership accountability to lead high performing teams. S/he will serve as the key contact for the Janssen IIS and collaborative study processes within the Janssen Companies and will represent GCDO-MAO in senior leadership/project teams as appropriate.
The Global Operations Lead – IIS Collaborative will:
• Act as a Single Point of Accountability (SPOA) for IIS and collaborative studies facing key stakeholders
• Lead the GCDO-MAO IIS Community of Practice (CoP) with regional representatives
• Act as a process owner for GCDO IIS Work Instruction
• Be responsible for harmonization of processes/support with flexibility within region
o Fair Market Value (FMV), Contracting Support, Contract and budget templates
o Drug Product support/processes
o IIS Algorithms
o System implementation (e.g. mCTMS, vTMF)
• Evaluate collaborative (“hybrid”) type studies as to IIS like or company sponsored
• Act as IIS and collaborative study SME for other processes; safety reporting, Cross-Pharma IIS SOP, Cross-sector initiatives, Global Blue Team, etc.
• Be accountable for audits/CAPA implementation for IIS or collaborative study related issues (e.g. safety reporting, FCPA, HCC, financial)
• Act as training curriculum owner for GCDO IIS administration roles (separate training for those solely working on IIS)
• Establish strong interaction with the GCDO-MAO COHs and other personnel involved with IISs and collaborative studies such as Functional Planning, Procurement, Finance, Legal, Global Medical Safety, etc.
• Be responsible for the line management and development of Regional Operational Leaders (ROLs)/CPLs and Collaborative Operational Leader (COL) and other roles assigned.
• Support the development of Human Resources Planning programs including Performance and Development Management (PDM) and training to meet current employment opportunity and the value of a diverse work force.
• A minimum of a Bachelor’s degree or equivalent University degree in Biology, Chemistry, Biochemistry, Nursing, Pharmacy, or related field is required
• A minimum of 10 years of clinical trial experience in biotech, pharma or CRO environment is required
• Experience in Investigator Initiated Studies (IIS) and/or collaborative studies is preferred
• Experience in R&D, global, regional and local Medical Affairs is preferred
• Excellent people leadership skills in a matrix environment and people management experience is preferred
• Effective leadership and communication skills and proven ability to foster team productivity and cohesiveness and managing global or regional teams in a virtual environment is required
• In-depth knowledge of global regulatory, quality and logistical aspects of global and local clinical trial conduct and oversight is required
• This position will require up to 20% domestic and international travelPrimary Location
United States-New Jersey-TitusvilleOther Locations
North America, Europe/Middle East/Africa, Latin America, Asia PacificOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial Coordination