Janssen 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,
At the 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.
We 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
To learn more
- 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 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 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 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
- 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.
- 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
- Ensures that environmental
analysis, protocol feasibility and country & site selection process is
conducted within timelines.
- 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
- 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.
- 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 CRO.
- Oversee the Clinical Trial
Manager (CTM) in the set-up and coordination of Investigator Meetings, if
- 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 as required.
- 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
- The GTL may be involved in
coaching/mentoring of other GTLs and Trial Team members, as well as
- The GTL does not have any
- 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).
- Relevant experience in Oncology
- Experience executing Phase II
& III clinical trials
Johnson & Johnson is an equal opportunity employer
United States-New Jersey-RaritanOther Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function