Senior Director, Risk Management and Central Monitoring
Company: Disability Solutions
Location: Princeton
Posted on: October 19, 2024
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Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more: .Senior
Director, Risk Management and Central Monitoring Position is a
critical member of the Clinical Oversight and Risk Management
Leadership Team and accountable to develop and drive Risk Based
strategies to enable the efficient and effective execution of
clinical trials through monitoring and data oversight. Key
strategic and tactical activities include the execution of the
strategic vision for the organization, and to enable a highly
efficient and engaged organization through operational directives
and key initiatives.The role is accountable for defining the RBM
strategy, collaborating with stakeholders to ensure buy in and
leading the Risk Management and Central Monitoring team,
responsible for supporting delivery of reliable clinical trial
information for internal decision making, regulatory approval and
market acceptance, and ensure a holistic community of practice
centered on quality by design, clinical trial risk management,
efficient issue management, and continuous improvement.The role
will need to play an instrumental role in collaborating and
negotiating with VP level peers in the broader Drug Development
organization to facilitate risk discussion at portfolio level and
would operate for a specific TA The insights that come from the
RM_CM TA specific team will be used for decision making at site,
study, country, portfolio level. The Senior Director, Risk
Management and Central Monitoring, is an industry thought leaders
and seeks understanding of what industry best practice is and is
engaged in industry leading forums for bringing industry standards
in centralized monitoring into BMS.This role is expected to be in
office 50% of the time over 2 weeks per company policy.Key
Responsibilities- Drive the development of and deliver the vision,
strategy and road map, in partnership with the CORM LT, to build a
holistic and integrated Risk Management and Central Monitoring
capability and processes to drive proactive risk-based management
and related data insights that enable BMS Drug Development to
accelerate in performance and safeguarding the well-being of our
trial participants.- Lead and shape the Risk Management and Central
Monitoring TA specific team, enabling them to lead execution of the
Risk Based Management Framework, enhancement of quality, compliance
and inspection readiness across the clinical trials (Phase 1-4) in
the portfolio.- Lead and manage governance for ongoing review of
portfolio risk to support successful delivery of portfolio
priorities for specific TA-Is accountable for implementing an
effective quality by design and risk-based management approach.-
Accountable for monitoring holistic quality of GDO activities
across the portfolio, identifying risks and supporting functions to
remediate gaps.-GDO point of contact for Quality oversight in RBM
implementation, driving best practice and improved quality for
clinical trials- Seeks understanding of what industry best practice
is and is engaged in industry leading forums for bringing industry
standards in centralized monitoring into BMS.-Accountable for the
identification and/or escalations of significant operational,
quality and compliance risks within established risk management
framework and councils. Participates in investigations and
mitigation measures.- Develops strong and productive working
relationships with key stakeholders throughout BMS, demonstrates
the ability to think strategically across R&D, and effectively
influence peers and senior management.- Collaborates with Global
Development Operations, Quality Assurance, and process owners to
ensure that processes, SOPs, oversight, and governance meet the
needs of the organization and evolving regulatory expectations.-
Provides leadership and oversight to the Risk Management and
Central Monitoring process and audits ensuring quality readiness
for regulatory inspections.- Develop and implement the strategy to
incorporate automation and emerging technologies to support risk
identification and management.- Provides ongoing feedback,
coaching, and career development, including engagement and
retention support to staff in order to maximize their potential.
Empower and hold staff to high quality performance and delivery.-
Engages and energizes employees through communication of goals,
priorities and other business critical information as well as focus
on employee value proposition, development and retention
activities.- Develop and promote a workplace culture that values
diversity of thought, promotes integrity, and creates an atmosphere
that supports coaching and fosters accountability.Qualifications &
Experience-A minimum of a Bachelor's degree (or equivalent degree)
is required-Degree in a life science, natural science, or business
is preferred-Broad knowledge of the global drug development
processes is required, with at least 10 years GCP-related
experience in clinical operations (e.g. site, sponsor, and/or
CRO).- Would operate for a specific TA' so would have relevant TA
experience to shape thinking.-Inspection experience is a
plus-Experience in and/or knowledge of centralized monitoring and
risk management in a regulated industry.-Enterprise Risk Management
knowledge is preferred-Experience in managing teams of diverse
individuals, ability to operate in a matrix organization and manage
competing priorities with a sense of urgency.- Engaged in industry
leading forums related to risk management and central
monitoring.-The candidate will demonstrate the ability to adopt a
biopharma enterprise-wide mindset, to act with speed,
accountability, and integrity.- Demonstrated team and matrix
leadership, escalation, enterprise and senior leadership
alignment.- Knowledge of external health authority and industry
trends and emerging areas of interest.If you come across a role
that intrigues you but doesn't perfectly line up with your resume,
we encourage you to apply anyway. You could be one step away from
work that will transform your life and career. Uniquely Interesting
Work, Life-changing CareersWith a single vision as inspiring as
Transforming patients' lives through science--- , every BMS
employee plays an integral role in work that goes far beyond
ordinary. Each of us is empowered to apply our individual talents
and unique perspectives in an inclusive culture, promoting
diversity in clinical trials, while our shared values of passion,
innovation, urgency, accountability, inclusion and integrity bring
out the highest potential of each of our colleagues.On-site
Protocol BMS has a diverse occupancy structure that determines
where an employee is required to conduct their work. This structure
includes site-essential, site-by-design, field-based and
remote-by-design jobs. The occupancy type that you are assigned is
determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned
facility. Site-by-design roles may be eligible for a hybrid work
model with at least 50% onsite at your assigned facility. For these
roles, onsite presence is considered an essential job function and
is critical to collaboration, innovation, productivity, and a
positive Company culture. For field-based and remote-by-design
roles the ability to physically travel to visit customers, patients
or business partners and to attend meetings on behalf of BMS as
directed is an essential job function. BMS is dedicated to ensuring
that people with disabilities can excel through a transparent
recruitment process, reasonable workplace
accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to . Visit to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your area.If
you live in or expect to work from Los Angeles County if hired for
this position, please visit this page for important additional
information: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, Union , Senior Director, Risk Management and Central Monitoring, Executive , Princeton, New Jersey
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