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
Program Leader - Neuroscience, located preferably at a J&J site in
North America, such as Raritan, NJ or other J&J sites such as Titusville
NJ, Springhouse PA, Canada, or European site locations preferably in United
Kingdom, Beerse Belgium, Leiden
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.
& 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.
We are Janssen. Our mission drives us. Our patients inspire
us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the
uniqueness of our employees and committed to inclusion
- Primary global accountability for GCDO program-
(IDP) level operational delivery with regard to time, quality and budget. The
position is a member of a (Therapeutic Area) Clinical Team, or an equivalent
cross-functional strategic team, and provides operational expertise and input
into the strategic planning and execution of a global clinical development
program/ or group of clinical trials.
- Key accountabilities include: robust strategic
operational planning; ensuring full integration of GCDO resources and budget to
the assigned program(s); obtaining alignment on (out)sourcing strategy; GCDO
Trial Leader (GTL) resource allocation; overseeing matrix team assignments; and
ensuring deliverables are met within agreed timelines, with high quality and
meeting Janssen’s procedural, ICH-GCP and regulatory requirements.
- Proactive risk management and mitigation
planning from the start of a clinical development program (IDP) till closure.
- This position acts as the single point of
accountability within GCDO at the global program level, and has a strong
leadership accountability to lead high performing teams.
- The position serves as the key contact for the
Janssen Therapeutic Area Clinical Leaders/ other Janssen Companies or external
development partner companies and will represent GCDO in (senior)
leadership/project teams as appropriate.
- This position is responsible for ensuring
alignment on business goals and TA/programs objectives, and leads the GCDO
cross functional matrix team. The position leads a team of Global Trial
Leaders, is responsible for ensuring consistencies across trials, and leverages
synergies and innovative approaches across a program. The position will oversee
GCDO resourcing and is a key contact for the (Clinical) Project Management Lead
for the duration of the program.
- This position directly supervises a group of
GCDO Trial Leaders and is accountable for the management and development of
staff within his/her scope of responsibility while fostering a diverse work
force that works seamlessly in a highly matrixed environment.
- Single point of accountability for providing
strategic operational input to the clinical development plan, building the
strategic operational plan and budget for GCDO deliverables and milestones, and
provide global leadership to the execution to plan and/or define risk mitigation strategies and ensures
implementation within GCDO thereof.
- Provides direct supervision and people
management responsibility for all GTL staff within his/her group
- Creates and gains endorsement of the global
strategic operational plan (IDP/program level), inclusive of the sourcing
strategy, supplier selection strategy, an aligned country selection plan and
ensures an integrated data plan for external data streams is available and
- Oversees clinical trial budget forecasting and
management inclusive of OOP and FTE estimates
- Leads CRO selection, ensures scope of work is
defined and is responsible to define deliverables, turnaround times, and
quality and performance levels for new sourcing needs.
- A minimum of a Bachelor’s degree in a scientific
discipline is required.
- An advanced degree (e.g., Masters, MBA, MD, PhD)
- Minimum of 10 or more years of experience in
clinical development, with Leadership Competencies, along with a proven track
record of global clinical operational experience (Phase 1-3B) or strong
clinical project management experience in biotech, pharma or CRO environment is
- Excellent people leadership skills in a matrix
environment is required, people management experience is strongly preferred.
- Profound experience in managing external
stakeholders/CROs programs is required.
- Solid knowledge of global regulatory, quality
and logistical aspects of global and local clinical trial conduct and oversight
- Proven experience in leading a global R&D registration
program is required.
- Early development / clinical pharmacology
experience is required.
- Sound clinical financial acumen; experience with
managing budgets is required.
- CRO management experience is preferred.
- Trusted, inclusive, leader with demonstrated
experience in managing and mentoring global, cross functional matrix teams and
a proven ability to foster team productivity and cohesiveness is required.
- Ability to provide strategic leadership, proven
decision making skills, strong negotiating and conflict resolution skills is
- Willingness and ability to travel up to 15-20%
of the time, defined by business needs is required.
& Johnson is an equal opportunity employer.
United States-New Jersey-TitusvilleOther Locations
North America-United States-Pennsylvania-Spring House, North America-Canada, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research non-MD