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GCDO Program Leader Infectious Diseases
Beerse, Belgium; High Wycombe, United Kingdom; Breda, Netherlands; Leiden, Netherlands; Raritan, New Jersey; Titusville, New Jersey; Spring House, Pennsylvania
Clinical Trial Coordination
Requisition ID: 1805640452W
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world and employs more than 4,000 professionals in Belgium. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
The position of Global program Leader- Infectious Diseases has 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. 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 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.
Is a 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.
2. 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.
3. 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.
4. 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 GCDO budget and change control at the program level.
5. 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.
6. 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, BRQ&C and GCDO 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 GCDO functions.
7. Represents GCDO at the Clinical Team and is responsible to timely and effectively communicate strategic direction and milestones, risks and interdepencies to the GCDO roles or Clinical Team. a. Lead GCDO 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 GCDO organization potentially impacting the delivery of the clinical trials or program and support the mitigation planning d. Responsible to invite the GCDO 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 CROs
8. 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
9. Supports Licensing and Acquisition activities and Due Diligence activities by providing operational input and assessments, as needed.
EDUCATION AND EXPERIENCE REQUIREMENTS:
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.
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.
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.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Coordination