Global Program Leader, Infectious Disease
Posted on Apr 6, 2021 by Johnson & Johnson
Janssen Research & Development, L.L.C., a division of Johnson & Johnsons Family of Companies is recruiting for a Global Program Leader, Infectious Diseases to be based in Spring House, PA, Titusville, NJ, Raritan, NJ, United Kingdom OR the Netherlands.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The position has primary global accountability for Global Development (GD) program- (IDP) level operational delivery with regard to time, quality and budget. The position is a member of an Infectious Disease 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 GD resources and budget to the assigned program(s); obtaining alignment on (out)sourcing strategy; Global 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. As such, the position is accountable for 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 GD 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 GD in (senior) leadership/project teams as appropriate.
This position is responsible for ensuring alignment on business goals and TA/programs objectives and leads the GD 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 GD 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 Global 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.
Is a single point of accountability for providing strategic operational input to the clinical development plan, building the strategic operational plan and budget for GD deliverables and milestones, and provide global leadership to the execution to plan and/or define risk mitigation strategies and ensures implementation within GD thereof.
Provides direct supervision and people management responsibility for all GTL staff within his/her group. Overall responsibility to ensure role training for his/her team are completed and current. Support the development of Human Resources programs which include performance development, talent management and training requirements.
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.
Ensures the predictable delivery of clinical operations, data & writing activities across the program within the agreed upon budget and timelines. Oversees clinical trial budget forecasting and management inclusive of OOP and FTE estimates. Is accountable for GD budget and change control at the program level.
Leads CRO selection, ensures scope of work is defined and is responsible to define deliverables, turnaround times, quality and performance levels for new sourcing needs. Is accountable for strategic alliance CRO budget for fully outsourced studies and supports contracting and change order management.
Ensures appropriate quality oversight to both insourced and outsourced trials. Ensures timely and appropriate issue escalation by GTLs and is responsible to appropriately escalate issues to clinical teams, BRQC and GD management and drive resolution or corrective actions. Provides leadership during Health Authority inspections and on the identification of risks and mitigation plans at program level for GD functions.
Represents GD at the Clinical Team and is responsible for timely and effectively communicate strategic direction and milestones, risks and interdependencies to the GD roles or Clinical Team.
Lead GD Matrix teams (GTLs and IDAR lead roles) at a program level or trial level, as applicable.
Ensures consistency within a clinical development program and/or leverage expertise or innovations across trial teams.
Responsible for identification of risks, within and outside the GD organization potentially impacting the delivery of the clinical trials or program and support the mitigation planning
Responsible to invite the GD subject matter expert to the relevant discussion in the clinical team as needed.
e. Ensures review of performance metrics, resourcing, and quality indicators and ensure corrective actions are being implemented for the program/trials, inclusive of activities outsourced to CRO.
Establishes strong interaction with R&D Partners, and leadership roles in R&D Operations, PMO, BRQC, Regulatory, Finance, Procurement in the clinical team or working groups for the clinical program to assure end to end oversight and leverage of best practices
Supports Licensing and Acquisition activities and Due Diligence activities by providing operational input and assessments, as needed.
Minimum of a Bachelors Degree in a scientific discipline is required. An advanced degree (eg, 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.
Excellent people leadership skills in a Matrix environment is required, people management experience is strongly preferred.
Willingness and ability to travel up to 15-20% of the time, defined by business needs.
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 for late development assignments. Early development/clinical pharmacology experience is required for early development portfolio assignments.
Sound clinical financial acumen; experience with managing budgets is required. CRO management experience is preferred.
The following skills are required to be considered further:
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 able to balance the customer needs and the business demands.
Ability to provide strategic leadership, proven decision making skills, strong negotiating and conflict resolution skills
Excellent communication and influencing skills and ability to establish strong relationships in a global Matrix environment as well as the innate flexibility to work in a rapidly growing and changing organization.
In addition, the following competencies are required: collaboration and teaming, integrity and Credo based- actions, results and performance driven, sense of urgency, managing complexity, analytical skills, customer and external orientation.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability