J&J Family of Companies Associate Director Global Trial Leader in Indianapolis, Indiana
Associate Director Global Trial Leader - 2206092186W
Johnson & Johnson is currently recruiting a Associate Director Global Trial Leader. This position will be located in New Brunswick, NJ. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.
At J&J, 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 collaborate with the world for the health of everyone in it. The Lung Cancer Initiative (LCI), which is both a cross-sector and World Without Disease effort, is charged by the Executive Committee of J&J with meaningfully altering the course of lung cancer and improving survival by preventing, intercepting, and curing lung cancer.
Associate Director Global Trials Leader (GTL) Summary:
The Lung Cancer Initiative/New Ventures Associate Director Global Trial Leader (GTL) has primary global accountability at the trial level within the LCI/NV organization. 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 LCI/NV and cross-sector 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.
Leads the cross-functional Trial Team including tracking project deliverables and ensuring regional/global clinical operations deliverables progress as scheduled.
Accountable for delivery of global trials within agreed/projected life of trial budget.
Ensure that protocol feasibility and country and site selection processes are conducted within timelines.
Develop the trial ESP strategy for assigned trials in line with the overall program ESP strategy.
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.
Creates/Updates study-specific documents such as IMP related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, and External Service Provider Oversight Plan.
Strong interaction with the Therapeutic Area, other LCI/NV functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Clinical Pharmacology and external partners to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome.
Cross-functional trial team members have a dotted line reporting project deliverables into GTL. GTL will assign trial related deliverables to trial team members.
Education and Experience Requirements:
Minimum 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 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.
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.
The anticipated base pay range for this position is $124,000 to $216,301.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
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 full 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 .
Primary Location NA-US-New Jersey-New Brunswick
Other Locations NA-United States
Organization Johnson & Johnson Enterprise Innovation Inc. (6268)
Job Function Clinical Trial Coordination
Req ID: 2206092186W
J&J Family of Companies
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