Vacancy expired!
Janssen Research and Development, L.L.C.,
a member of Johnson and Johnson's Family of Companies, is recruiting for a
Global Clinical Development Operations (GCDO) Trial Leader. This position can be located in Spring House, PA; Titusville, NJ; Raritan,
NJ; La Jolla, CA; Beerse, Belgium; High Wycombe, United Kingdom; Leiden, Netherlands
or Breda, Netherlands.
Remote locations within the United States and Europe may be considered.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. And we pursue
the most promising science, wherever it might be found. Janssen
Research & Development, LLC discovers and develops innovative medical
solutions to address important unmet medical needs in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Please visit
http://www.JanssenRnD.com for more information.The Global Clinical Development Operations
(GCDO) Trial Leader (GTL) will have primary global accountability at the trial
level within the GCDO organization. The
GTL will provide operational expertise for the successful cross-functional
delivery of assigned early development clinical trial(s), within agreed
timelines and budget, and in alignment with all the applicable Standard
Operating Procedures (SOPs) and regulatory requirements.Principal
Responsibilities:
Oversight of external service
providers (ESP), including ESP contracts and budgets. In addition, this individual will be involved
in planning and execution of both internally managed and outsourced trials,
with scope from draft protocol elements document to availability of the
Clinical Study Report and applicable disclosure of the trial results.
Lead the cross-functional Trial
Team (including GCDO and non-GCDO members) and collaborate with all trial team
members, building the trial operational plan, in alignment with the
organizational and the Therapeutic Area (TA) Clinical Team’s objectives. Define risk mitigation strategies and ensure
implementation thereof.
Maintain oversight of the trial by
taking an operational leadership role in a matrix organization, which 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.
Identify risks and ensure
mitigation and contingencies are being initiated and followed through
(including management of Corrective and Preventive Action Plans).
Overall trial budget and contract
management, including updates for scope changes, review and approval of ESP
contracts, change orders and ensure services are delivered.
Drive the final study placement and
ensure alignment with and communication to the involved partners, including TA
and regional GCO TA experts.
Develop the trial ESP strategy for
the assigned trial in line with the overall program ESP strategy.
Clinical Research Organization (CRO)
management, including initiation of selection process, Statement of Work (SOW)
development, budget and change orders and oversight of all deliverables
outsourced to the CRO.
Build and update study-specific
documents, such as Monitoring Guidelines, Informed Consent Form, IMP related
documentation, Blinding Plan, country and site feasibility related documents,
Safety related documents, Protocol Deviations and Issue processes, ESP Oversight
Plan, Filing and Archiving Plan.
Participate in preparation for,
Health Authority inspections and internal QA audits.
Drive lessons learned initiatives
at trial level during and after trial achievement completion. Develop subsequent issue resolution and
process improvements as required.
Strong interaction with the
Therapeutic Area, other GCDO functions, Biomarker groups, Clinical
Pharmacology, 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.
Qualifications
A minimum of a Bachelor’s or equivalent
University degree is required, preferably in a scientific discipline (e.g.
Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
A minimum of 8 years of clinical trial
experience within the Pharmaceutical industry or Clinical Research Organization
(CRO) is required.
Experience in any of the following
Therapeutic Areas preferred: Oncology, Neuroscience, Immunology,
Cardiovascular, Metabolism, Infectious Diseases, Vaccines.
An exploratory scientific mindset
with focus on disease area and Pharmacokinetics/biomarkers is preferred.
The ability to lead all aspects of
execution of a clinical trial is required.
Experience with vendor management
is required.
People management experience is
strongly preferred.
Must have excellent people
leadership skills.
Must have strong communication
skills.
The ability to collaborate with all
levels and influence decision-making in a global, matrix environment is
required.
This position will require up to
20% domestic and international travel.
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 LocationUnited States-Pennsylvania-Spring House-Other LocationsNorth America-United States-California-La Jolla, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Netherlands-North Brabant-BredaOrganizationJanssen Research & Development, LLC (6084)Job FunctionClinical Trial CoordinationRequisition ID4744190913
Vacancy expired!