Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Global Trial Leader. This position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; High Wycombe, United Kingdom; Leiden, Netherlands; or Breda, Netherlands. Remote locations within North America and Europe may be considered.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming 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 www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Global Trial Leader (GTL) has primary global accountability at the trial level within the Global Development (GD) organization. The GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The GTL is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document (PED) to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results.
The GTL is responsible for leading the cross-functional Trial Team (including GD and non-GD members) and interfaces with all trial team members, building the trial operational plan, is responsible for ESP contracts and budget, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team (CT)’s objectives. The GTL provides global operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof.
The GTL maintains oversight of the trial by taking an operational leadership role in a matrix organization, while scientific leadership is provided by the Study Responsible Physician. This includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.
- Leads the cross-functional Trial Team; Tracking of Project Deliverables & Timelines using Functional Planning tools and support. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
- Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs. Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Ensure that protocol feasibility and country and site selection processes are conducted within timelines. Endorses the final study placement and ensures alignment with and communication to study team members from TA and Global Development.
- Develop the trial ESP strategy for his/her assigned trial in line with the overall program ESP strategy. Is accountable for oversight of all external service providers used for the trial for both inhouse and outsourced studies. Is responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget and timelines. During execution, the GTL will ensure escalated issues are appropriately resolved. For outsourced trials is responsible for CRO management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO. Is primary point of contact for the assigned Project Director/Manager from the CRO responsible for the trial.
- Ensures Trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensures that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Quality Management & Compliance liaisons to ensure quality oversight of assigned trial utilizing the available tools.
- Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Responsible Physician (SRP), the GTL ensures appropriate trial-specific training is given to Trial Team members or to the CRO. Oversee the Clinical Trial Manager (CTM) in the set-up and coordination of Investigator Meetings, if applicable.
- Responsible to ensure transparent status reporting information to relevant key stake holders in Janssen R&D.
- Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they cannot be resolved within the function and/or Trial Team they are escalated to the Global Program Leader (GPL) and Clinical Team level, as necessary. Manages timely and accurate documentation of issue escalation. Accountable to drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required.
- Strong interaction with the Therapeutic Area, other GD functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome.
- This position reports to the GPL. The GTL leads a matrixed cross-functional trial team, with minimal guidance from the GPL and provides feedback into performance of matrix team members. The GTL may be involved in coaching/mentoring of other GTLs and Trial Team members, as well as interviewing/selection process. The GTL does not have any direct reports. a. Cross-functional trial team members have a dotted-line reporting project deliverables into GTL. GTL will assign trial related deliverables to trial team members. Able to identify and to drive process initiatives within GD.
Contacts in the organization include but are not limited to: Global Operations Head, Global Program Leader, Clinical Trial Managers (CTM), Clinical Trial Assistant, Clinical Functional Planner, cross-functional members of the CWG: Study Responsible Physician/Study Clinical Scientist, Global Data Manager, Central Monitoring Manager, Statistical Programmer, Biostatistician, Regulatory Medical Writer, Clinical Supplies Integrator and Trial Supply Manager, Quality and Compliance Manager, Quality Assurance Group, Business Operations Manager, Finance representatives, Janssen R&D Procurement representatives, Regulatory representatives, Different members of the Therapeutic Areas and of the Clinical team: Medical Leader, Clinical Program Management Leader contacts outside of the organization: Multiple vendors, Key Opinion Leaders/Principal InvestigatorsQualifications
- BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy),
- Minimum of 8 years clinical trial experience in the pharmaceutical industry or CRO.
- Willingness and ability to travel up to 15-20% of the time, defined by business needs.
- Requires clinical research operational knowledge, project planning/management, communication and presentation skills.
- Must have the ability to manage all aspects of execution of a clinical trial.
- Experience managing or leading global or regional teams in a virtual environment is required.
- Strong expertise in vendor management required.
- Retinal / Ophthalmology experience is preferred
- Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness. Excellent decision-making, analytical and strong financial management skills are essential to this position. Operates and executes with limited supervision.
- Experience mentoring/coaching others. Ability to support and participate in the hiring, training, development and evaluation of staff on a regular basis.
- Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- In addition, the following competencies are required:
- LEAD: drive decision making, excellent leadership skills, leading in a matrix environment
- DELIVER: manage priorities effectively to deliver results, acts with speed, flexibility & accountability to achieve goals
- CONNECT: foster team cohesiveness in global environment
- SHAPE: identifies & communicates meaningful risks, takes advantage of opportunities to have a positive impact
- CREDO: create a trusting, collaborative and ethical work environment, lead credo-based decisions, maintain high standards of quality, ethics and compliance.
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.Primary Location
United States-New Jersey-Raritan-920 US Highway 202Other Locations
Europe/Middle East/Africa, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United StatesOrganization
Janssen Research & Development, LLC (6084)Job Function