Global Clinical Development Operations Program Leader
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Global Clinical Development Operations Program Leader - Neuroscience, located preferably at a J&J site in North America, such as Raritan, NJ or other J&J sites such as Titusville NJ, or Springhouse PA.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion
• Primary global accountability for GCDO program- (IDP) level operational delivery with regard to time, quality and budget. The position is a member of a (Therapeutic Area) Clinical Team, or an equivalent cross-functional strategic team, and provides 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 (out)sourcing strategy; GCDO Trial Leader (GTL) resource allocation; overseeing matrix team assignments; and ensuring deliverables are met within agreed timelines, with high quality and meeting Janssen’s procedural, ICH-GCP and regulatory requirements.
• Proactive risk management and mitigation planning from the start of a clinical development program (IDP) till closure.
• This position acts as the single point of accountability within GCDO at the global program level, and has a strong leadership accountability to lead high performing teams.
• The position serves as the key contact for the Janssen Therapeutic Area Clinical Leaders/ other Janssen Companies or external development partner companies and will represent GCDO in (senior) leadership/project teams as appropriate.
• This position is responsible for ensuring alignment on business goals and TA/programs objectives, and leads the GCDO cross functional matrix team. The position leads a team of Global Trial Leaders, is responsible for ensuring consistencies across trials, and leverages synergies and innovative approaches across a program. The position will oversee GCDO resourcing and is a key contact for the (Clinical) Project Management Lead for the duration of the program.
• This position directly supervises a group of GCDO Trial Leaders and is accountable for the management and development of staff within his/her 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 ensures implementation within GCDO thereof.
• Provides direct supervision and people management responsibility for all GTL staff within his/her group
• Creates and gains endorsement of the global strategic operational plan (IDP/program level), inclusive of the sourcing strategy, supplier selection strategy, an aligned country selection plan and ensures an integrated data plan for external data streams is available and endorsed.
• Oversees clinical trial budget forecasting and management inclusive of OOP and FTE estimates
• Leads CRO selection, ensures scope of work is defined and is responsible to define deliverables, turnaround times, and quality and performance levels for new sourcing needs.
• A minimum of a Bachelor’s degree in a scientific discipline is required.
• An advanced degree (e.g., Masters, MBA, MD, PhD) is preferred.
• Minimum of 10 or more years of experience in clinical development, with Leadership Competencies, along with a proven track record of global clinical operational experience (Phase 1-3B) or strong clinical project management experience in biotech, pharma or CRO environment is required.
• Excellent people leadership skills in a matrix environment is required, people management experience is strongly preferred.
• Profound experience in managing external stakeholders/CROs programs is required.
• Solid knowledge of global regulatory, quality and logistical aspects of global and local clinical trial conduct and oversight is required.
• Proven experience in leading a global R&D registration program is required.
• Early development / clinical pharmacology experience is required.
• Sound clinical financial acumen; experience with managing budgets is required.
• CRO management experience is preferred.
• Trusted, inclusive, leader with demonstrated experience in managing and mentoring global, cross functional matrix teams and a proven ability to foster team productivity and cohesiveness is required.
• Ability to provide strategic leadership, proven decision making skills, strong negotiating and conflict resolution skills is required.
• Willingness and ability to travel up to 15-20% of the time, defined by business needs is required.
Johnson & Johnson is an equal opportunity employer.
United States-New Jersey-Titusville
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination