Clinical Trial Physician/Sr. Clinical Trial Physician (Immunology)
Company: Disability Solutions
Location: Princeton
Posted on: October 19, 2024
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: .The
Clinical Trial Physician sits within Clinical Development, which is
a global organization dedicated to the effective design and
execution of drug development. Clinical Development drives clinical
development strategy, design, execution, and interpretation of
clinical trials.Position Summary / Objective
- Serves as a primary source of medical accountability and
oversight for clinical trials
- Matrix management responsibilities across the internal and
external network
- Manages Phase 1 - Phase 3 studies, with demonstrated decision
making capabilities
- Provides medical and scientific expertise to cross-functional
BMS colleaguesPosition Responsibilities Medical Monitoring
- Contributes to and is a key member of a high performing Study
Delivery Team (SDT) and may be a member of the Clinical Development
Team (CDT)
- Conducts medical data review of trial data, including
eligibility review
- Holds responsibility for site interactions in partnership with
the Clinical Scientist (CS) for medical questions and education
(including safety management guidelines)
- Holds responsibility for assessment of key safety-related
serious adverse events in partnership with Worldwide Patient Safety
and oversees safety narratives
- Collaborates with CS and inputs into protocols, providing
medical strategic oversight in protocol development (input on
inclusion/exclusion and other safety-related clinical
considerations)
- Fulfills GCP and compliance obligations for clinical conduct
and maintains all required training Clinical Development Expertise
& Strategy
- In collaboration with the Clinical Development Lead, designs
and develops clinical plans and protocols with a strong strategic
focus based on knowledge of asset/drug, disease area and relevant
science in order to meet regulatory and disease strategy
targets
- Provides oversight and medical accountability for a group of
studies
- Leads the analysis of benefit/risk for clinical development
protocols in a matrix team environment working with Clinical
Scientists
- Partners with CS to support executional delivery of studies
(e.g., site activation, enrollment status, as well as adjudication
for protocol violations, significant, non-significant deviations
etc.)
- Identifies and builds relationships with principal
investigators. Identifies and cultivates thought leaders in order
to gain their inputs on emerging science in drug and biomarker
research, disease knowledge, and design of clinical development
studies and programs
- Maintains a strong medical/scientific reputation within the
disease area. Has in-depth knowledge of etiology, natural history,
diagnosis, and treatment of the disorder. Keeps up-to-date in the
disease area by attending scientific conferences and ongoing review
of the literature
- Keeps abreast of development and regulatory issues related to
other competitive or relevant compounds in development and how our
portfolio fits into the competitive landscape
- Provides ongoing medical education in partnership with CS to
allow for protocol-specific training, supporting the study team,
investigators, and others Health Authority Interactions &
Publications
- Contributes to key Health Authority interactions and advisory
board meetings as Clinical Trial Physician
- Authors/drafts clinical content for CSRs, regulatory reports,
briefing books and submission documents to support closure,
clinical narratives, reporting and filling of the study in
partnership with Clinical ScientistsDegree Requirements
- MD required (or x-US equivalent)Experience Requirements
- 3 or more years of Industry experience and/or clinical trials
experience is requiredKey Competency Requirements
- Ability to communicate and present information clearly in
scientific and clinical settings
- Subspecialty training in applicable therapeutic area
desired
- Expertise in the scientific method to test hypotheses,
including statistical design, analysis, and interpretation
- Knowledge of drug development process
- Knowledge of the components needed to execute an effective
clinical plan and protocols
- Strong leadership skills with proven ability to lead and work
effectively in a team environmentTravel Required
- Domestic and International travel may be required. 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, Norwalk , Clinical Trial Physician/Sr. Clinical Trial Physician (Immunology), Healthcare , Princeton, Connecticut
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