Research and Development, L.L.C., a member of Johnson and Johnson's Family of
Companies, is recruiting for an Associate Director Clinical Research located
preferably in Spring House, PA, Raritan, NJ, Titusville, NJ, Leiden Netherlands
and/or Beerse, Belgium
Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is
helping people live full and healthy lives. We focus on treating, curing and
preventing some of the most devastating and complex diseases of our time. We
pursue the most promising science, wherever it might be found.
discover and develop innovative medical solutions to address unmet medical
needs in oncology, immunology, neuroscience, infectious diseases and vaccines,
and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com
- The GCDO Trial Leader (GTL) has primary
global accountability at the trial level within the GCDO 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
- 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 GCDO and non-GCDO 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
- 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
- The GTL 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
- The GTL 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.
- Ensures that environmental analysis,
protocol feasibility and country & site selection process is conducted
- Responsible to drive the final study
placement, and ensure alignment with and communication to the involved
stakeholders, including TA and RTAEs
- 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 in house 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
- 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
- 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
- Oversee the Clinical Trial Manager (CTM)
in the set-up and coordination of Investigator Meetings, if applicable.
- 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 GCDO Program Leader (GPL) and Clinical Team
level, as necessary.
- Accountable to drive lessons learned
initiatives at trial level during and after trial milestone completion;
accountable for developing subsequent issue resolution and process improvements
- Strong interaction with the Therapeutic
Area, other GCDO 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
- The GTL does not have any direct
- Cross-functional trial team members have
a dotted line reporting project deliverables into GTL. GTL will assign trial
related deliverables to trial team members
- You possess a Bachelor’s or higher degree, preferably in Life Sciences
(e.g., Biology, Chemistry, Nursing, and Pharmacy)
- You have 8 or more year’s
clinical trial experience in the pharmaceutical/ medical device industry
and or CRO.
- You are able to lead all
aspects of execution of a clinical trial and you demonstrate expertise
in vendor management.
- You excel in organizing and
motivating global or regional teams in a virtual environment.
- You are a coach and a
- Able to travel up to 20% of the
time, (as defined by business need).
- Experience executing Phase II
& III clinical trials
- Relevant experience in
associated Therapeutic Area
Johnson & Johnson is an equal opportunity employer
United States-Pennsylvania-Spring HouseOther Locations
North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial Coordination