Johnson & Johnson Careers
Director, Oncology Translational Research Clinical and Business Operations
Spring House, Pennsylvania
Requisition ID: 2553180529
Janssen Research & Development, L.L.C, a member of the Johnson & Johnson Family of Companies, is recruiting for a Director, Oncology Translational Research Clinical and Business Operations located in Spring House, PA with up to 15% travel.
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, Oncology Translational Research Clinical Operations (OTR) Clinical Operations is a key member of the OTR Senior Leadership Team. The incumbent will assume rersponsibility for coordinating the execution of all activities across the OTR portfolio including, through leadership of an experienced operations team, all aspects of the implementation and execution of OTR programs in clinical studies, in close coordination with OTR scientists and clinical teams in Oncology Development.
In addition to leading the OTR clinical operations group, the incumbent will be responsible for management of the OTR operations and associated budget, including management of resources to support SLT operations, scientific review meetings and other operational interfaces within the Oncology TA and Janssen more broadly.
• Manage 10-12 reports
• Provide biomarker operational direction and leadership for clinical programs in the Oncology TA to ensure the delivery of biomarker activities are aligned with the biomarker strategy and clinical study timelines
• Responsible for scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of budget and resources
• Drive setting of biomarker operational program goals and milestones and monitor progress
• operational lead for alignment
• Create and manage TR program timelines, resources, budget, analyze risk and quality
• Maintain an overview of status and issues, and proactively communicate progress, challenges or changes that may impact timelines to relevant stakeholders, including OTR Senior Leadership, OTR Scientists and Clinical Teams
• Responsible for biomarker operations program-level decision making, risk identification and mitigation planning, ensuring escalation and resolution as appropriate
• Responsible for leading the aligned identification and selection of biomarker vendors across programs with the appropriate Subject Matter Expert (SME), Quality and Procurement
• Chair relevant operational meetings, where applicable, involving internal or external stakeholders
• Ensure escalation of issues and risks that significantly affect biomarker program timelines, budget or quality to management
• May recruit, manage and provide leadership, strategic direction for new staff
• A Master’s Degree with 10 years industry related experience is required.
• In depth knowledge and understanding of ICH, GCP is required.
• Knowledge of clinical sample operations and logistics through extensive participations with clinical teams is strongly preferred.
• Proven experience in planning and executing clinical and or biomarker operations is required.
• Understanding and critically assess the global clinical development plans, protocol design, resources needs, global budgets and timelines for programs applicable to biomarker operations strategy is required.
• Strong leadership and motivational skills developed through leading successful multi-functional matrix teams is required.
• Ability to maintain knowledge of novel scientific technologies & platforms that may impact planning or ongoing operational strategies is required.
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)