Global Trial Leader (1 of 6 positions)

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Global Trial Leader (1 of 6 positions). The position can be located in North America (US or Canada) or within Europe. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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.

Principal Responsibilities:

• 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 setup, 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.

Qualifications

• Bachelor's of Science degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is required.
• Minimum of 8 years clinical trial experience in the pharmaceutical industry or CRO is required.
• Willingness and ability to travel up to 15-20% of the time, defined by business needs is required.
• Requires clinical research operational knowledge, project planning/management, communication and presentation skills is required.
• Must have the ability to manage all aspects of execution of a clinical trial is required.
• Experience managing or leading global or regional teams in a virtual environment is required.
• Strong expertise in vendor management required.
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness is required.
• Excellent decision-making, analytical and strong financial management skills are essential to this position is required.
• Operates and executes with limited supervision is required.
• Experience mentoring/coaching others is required.
• Ability to support and participate in the hiring, training, development and evaluation of staff on a regular basis is required.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $150,300 to $259,210.

The anticipated base pay range for this position in all other US locations is $131,000 - $225,400.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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