Functional Manager, Global Clinical Operations

3 weeks ago

Raritan, New Jersey, United States Johnson & Johnson Full time
Janssen Research & Development LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for a Functional Manager, Global Clinical Operations - U.S. Oncology. This position can be located remotely within the United States.

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 for more information.

The Functional Manager, Global Clinical Operations (GCO) - U.S. Oncology will be accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. This individual will support the Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency.

Principal Responsibilities:
  • Provide line management to direct reports, including setting goals and objectives, performance evaluation and talent development.
  • Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
  • Support the flexible resourcing model and collaborate with flex resource managers to get qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
  • Interview, hire, develop and train staff.
  • Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports' training compliance.
  • Support direct reports in issue resolution and communication with involved stakeholders.
  • Support local implementation of organizational changes and effectively communicate on priority shifts.
  • Review and approve expenses in compliance with the company policies.
  • Demonstrate leadership behaviors in alignment with Johnson & Johnson Leadership Imperatives.
  • Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
  • Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
  • Support long term strategy in alignment with GCO, Global Development (GD) and Janssen R&D strategies to position the local and global GCO organization for success.
  • Oversight of execution and monitoring of clinical trials through all phases (from feasibility to closeout) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
  • Ensure relevant operational objectives are met in conformance to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP), relevant SOPs and other procedural documents.
  • Be accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.
  • Contribute to Corrective and Preventative Actions (CAPAs) and issue resolution in accordance with required timelines.
  • Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
  • Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
  • Be accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
  • Support regular metrics review and drive necessary follow-up actions.
  • Contribute to development, evaluation and implementation of new processes and systems to improve study management.
  • Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
  • Foster a culture of continuous improvement and innovation within the local GCO team.
  • Model Credo based culture within the local GCO team.

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