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GCDO Program Leader

  The Global Clinical Development Operations (GCDO) Program Leader (GPL) will have primary global accountability for GCDO program (IDP) level operational delivery with regard to time, quality and budget.  This individual will be a member of a Therapeutic Area (TA) Clinical Team, or an equivalent cross-functional strategic team, and will provide operational expertise and input into the strategic planning and execution of a global clinical development program or group of clinical trials.  Key accountabilities include: robust strategic operational planning; ensuring full integration of GCDO resources and budget to the assigned program(s); obtaining alignment on outsourcing strategy; resource allocation; overseeing matrix team assignments; and ensuring deliverables are met within agreed timelines, with high quality and meeting Janssen's procedural, International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and regulatory requirements.  Principal Responsibilities: Proactive risk management and mitigation planning from the start of a clinical development program (IDP) until closure. Act as the single point of accountability within GCDO at the global program level and be accountable for leading high performing teams. Serve as the key contact for the Janssen Therapeutic Area Clinical Leaders/other Janssen companies or external development partner companies and represent GCDO on senior leadership/project teams as appropriate. Ensure alignment on business goals and TA/program objectives and lead the GCDO cross- functional matrix teams.  Lead a team of GTLs to ensure consistencies across trials, and leverage synergies and innovative approaches across a program.  Oversee GCDO resourcing and be a key contact for the (Clinical) Project Management Lead for the duration of the program. Directly supervise a group of GTLs and be accountable for the management and development of staff within scope of responsibility while fostering a diverse work force that works seamlessly in a highly matrixed environment. Single point of accountability for providing strategic operational input to the clinical development plan, building the strategic operational plan and budget for GCDO deliverables and milestones, and provide global leadership to the execution to plan and/or define risk mitigation strategies and ensure implementation within GCDO. Create and gain endorsement of the global strategic operational plan (IDP/program level), inclusive of the sourcing strategy, supplier selection strategy and aligned country selection plan.  Ensure an integrated data plan for external data streams is available and endorsed. Oversee clinical trial budget forecasting and management. Lead CRO selection, ensure scope of work is defined and define deliverables, turnaround times, and quality and performance levels for new sourcing needs.   Qualifications A minimum of a Bachelor's or equivalent University degree is required, preferably in a scientific discipline (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).  Advanced degree (e.g. Master's, MBA, MD, PhD) is preferred. A minimum of 10 years of experience in clinical development within the Pharmaceutical industry or Clinical Research Organization (CRO) is required. Global clinical operational experience (Phase 1-3B) or clinical project management experience is required. Experience in managing external stakeholders/CRO programs is required. Knowledge of global regulatory, quality and logistical aspects of global and local clinical trial conduct and oversight is required. Experience leading a global R&D registration program is required. CRO management experience is preferred. People management experience is strongly preferred. Must have excellent people leadership skills. Experience managing budgets required. Must have strong financial acumen. Must have strong communication skills. Must have strong decision-making, negotiating and conflict resolution skills. The ability to collaborate with all levels and influence decision-making in a global, matrix environment is required. This position will require up to 20% domestic and international travel. Requisition ID: 7743181122
Salary Range: NA
Minimum Qualification
11 - 15 years

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