Global Program Leader

Janssen Pharmaceutical Companies of Johnson & Johnson is looking for

**Global Development (GD)-Portfolio Delivery Operations**

**Global Program Leader (GPL)**

The position has primary global accountability for GD 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 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.

**Principal Responsibilities**:

- 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.

a. Lead GD matrix teams (GTLs and IDAR lead roles) at a program level or trial level, as applicable.

b. Ensures consistency within a clinical development program and/or leverage expertise or innovations across trial teams.

c. 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

e. Ensures review of performance metrics, resourcing, and quality indicators a