1+ months

Director, Global Feasibility Therapeutic Area Head (1 of 6)

Johnson & Johnson
Hopewell Township, NJ 08560

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Global Feasibility Therapeutic Area (TA) Head.  This position can be located in North America or Europe within commuting distance of a Johnson & Johnson facility.  Remote locations may be considered.
 
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.
 
The Director, Global Feasibility TA Head (GFH) will have primary accountability for Global Clinical Development Operations TA level clinical trial feasibility delivery.  The scope of the position includes R&D trials, including Early Development, Late Development and Phase 3b / IV interventional trials.  The GFH will ultimately accountable for the successful delivery of feasibility activities for all clinical programs within the assigned TA(s) and will drive cross-functional feasibility operational strategies.  Successful delivery means within timelines and with good quality that support operational planning / decisions resulting in predictable delivery.  Ensure common operational issues / challenges are identified across programs and across functions and addressed through risk mitigation / appropriate escalation to the Portfolio Delivery Operations (PDO) and Global Clinical Operations (GCO), including proposals for alternative solutions.  Accountable for ensuring feasibility execution for insourced and outsourced programs.  Direct interface with TAs, Global Program Leaders (GPLs), and relevant Regional / Area management in GCO.  Lead a team of TA-aligned Global Feasibility Leads (GFL) and is a member of the feasibility functional leadership team.  Ensure that their TA-aligned team of GFLs is delivering high quality operational insights and partnering with the key stakeholders to create effective protocols and establish robust operational plans.
 
Principal Responsibilities:
  • Facilitate and drive development of TA level global feasibility strategies including: insights generation / data compilation / assessment and presentation in collaboration with program level stakeholders across GCDO and TA teams.
  • Lead the TA-aligned GFL team and is responsible for resourcing and performance management.
    Provide direct supervision and people management for all GFL staff within his/her group. Overall responsibility to ensure role training for his/her team are completed and current.  Support the development of Human Resources programs which include performance development, talent management and training requirements.
  • Ensure integration of feasibility inputs (data analytics of historical / current clinical trials, epidemiology, standard of care, local country input, etc.) that support global operational planning for clinical trials.
  • Ensure on-time and high-quality delivery of feasibility work and deliverables within the TA-aligned projects under remit, from operational plan to operational lock.
  • Ensure consistent standards are applied for the feasibility process across the portfolio in collaboration with peers on the feasibility functional leadership team and study and program teams.
  • Support development and delivery of global feasibility functional strategy.
  • Define and drive the feasibility business processes and leads continuous improvement efforts.
  • Develop a country engagement strategy for insights generation aligned with the clinical development plan and trial program footprint for each stage of the feasibility process in collaboration with PDO and GCO.
  • Ensure overviews of the evolving TA feasibility strategy are communicated to the GCO team to enable awareness of risks and challenges and facilitate GCO management input and alignment with feasibility needs.
  • Lead and facilitate specific study-level feasibility activities as required.
  • May assume GFL responsibilities for specific programs.
  • Provide leadership and direction for the global feasibility processes and TA-aligned GFL team.
  • Develop and manage a team of high performing individuals.
  • Ensure key stakeholders in the process are connected, communication is well established between central functional study team members, feasibility resources and country teams.
  • Support strategic direction and approaches that result in consolidation and presentation of operational recommendations / key considerations from feasibility process and derived insights that enhance study design and operational planning (country / site selection, recruitment planning, etc.).
  • Develop organizational capability that delivers global operational plans which meet organizational needs for time, cost and quality.
  • Ensure all projects are fully staffed/Capacity management.

Qualifications
 

Primary Location
United States-New Jersey-Titusville-
Other Locations
Europe/Middle East/Africa, North America
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Research non-MD
Requisition ID
6779181107
Posted: 2018-11-16 Expires: 2019-01-16

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Director, Global Feasibility Therapeutic Area Head (1 of 6)

Johnson & Johnson
Hopewell Township, NJ 08560

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