Global Clinical Development Operations Head of Strategic Partnerships

Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Global Clinical Development Operations Head of Strategic Partnerships. This position will reside in either Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, BE; Leiden; High Wycombe, UK and will require up to 20% global travel.

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.

We discover and develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Bring your talents to our mission, visit to learn more.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The position leads the Strategic Partnerships function in Global Clinical Development Operations (GCDO) and will be responsible and accountable to define and deliver the sourcing strategy to execute the portfolio of clinical activities for Janssen across all markets and all Therapeutic Areas.

Principal Responsibilities:

  1. Establish, maintain and communicate the Janssen holistic sourcing strategy for all clinical activities across all markets and Therapeutic Areas:
    1. Strategic Alliances with Contract Research Organizations (CROs) – all CROs supporting PhI – IV studies, including Medical Affairs and Clinical Pharmacology
    2. All IDAR partners supporting Data Management, Statistical Programming and Medical Writing
    3. Central and Local Lab partners
    4. eCOA (electronic Clinical Outcome Assessment) and ePRO vendors
    5. Imaging & IWRS - randomization systems
  1. Ensure timely, high quality and cost-efficient execution of key clinical trial activities with a total spend of >$650M
  2. Develop productive and effective partnerships with more than 40 external partners to deliver critical clinical trial activities in support of the Janssen portfolio
  3. Partner with JRP and BQRC to define and manage the partnership governance approach, including the oversight of quality performance metrics, escalation and resolution of quality issues.
  4. Ensure oversight of the Non-Core Country model to enable the execution of clinical trial activities outside of the Janssen GCO footprint
  5. Ensure all externally sourced clinical activities are conducted with the appropriate quality and in full adherence of all Health Authority and legal regulations as well as J&J CREDO standards.
  6. Lead and inspire a globally distributed organization of ~25 Strategic Partnership professionals. Accountable for ensuring that the organization works in a harmonized, efficient and effective way to drive towards customer satisfaction and partnership with GCDO, TA and Medical Affairs
  7. Ensures appropriate metrics, market intelligence and benchmarking are in place to assess vendor performance and where needed drive for improvements, innovation and influencing strategic direction of partner capability roadmaps
  8. Partner with Contracts & Grants and IPE to ensure Janssen ‘Partner of Choice’ is embedded in the externally sourced ways of working
  9. Provide oversight to all GCDO External Consulting activities in full alignment with ENHANCE guidelines
  10. Partner with JJCO and other sector leads to share best practices and align sourcing processes/approaches
  11. Active contribution in GCDO SLT and GCDO Portfolio Review to deliver GCDO’s goal of becoming the industry’s best Clinical Operations organization.

  • A Bachelor’s Degree or University equivalent in a scientific discipline is required; Master’s Degree is preferred
  • A minimum of 15 years’ successful experience in a scientific discipline, including 10+ years in the area of Outsourced Clinical Trials Management is required
  • Demonstrated knowledge and understanding of clinical development/drug development process, specifically in all aspects of outsourcing (CROs, labs, eCOA, IWRS, etc.) is required
  • Experience in strategic planning specifically in the quality management of clinical trial operations/execution is required
  • Knowledge about all Therapeutic Areas where Janssen has active studies is preferred
  • Experience across the entire R&D value chain from PhI FIH studies through to Medical Affairs studies is preferred
  • Experience in both in-sourcing as well as outsourcing models and CRO partnerships is required
  • Experience to lead, inspire and influence a globally distributed team through a period of high change, vision and strategy setting is required
  • Ability to manage complex technical organizations is preferred
  • Excellent people management, stakeholder management and leadership skills is requirement
  • A proven ability to execute and get results through leading others required
  • Demonstrated ability to collaborate internally and develop partnerships with key business partners and customers/investigators is required
  • Ability to work in a cross-functional and cross-cultural environment/matrix is required
  • Up to 20% international and domestic travel is required

Primary Location
United States-New Jersey-Raritan
Other Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
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