Clinical Trial Physician (CTP), Medical Evidence Generation - Neurology
Company: Disability Solutions
Location: Princeton
Posted on: May 3, 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:
careers.bms.com/working-with-us .The Clinical Trial Physician (CTP)
in the Worldwide Medical Evidence Generation (MEG) group will serve
as the primary source of medical/clinical accountability and
oversight for the various medical affairs-led sponsored studies
(interventional and non-interventional), in alignment with the
Integrated Evidence Plans for the assets in the company's
portfolio. He/she will work closely with the Clinical Trial Lead
(CTL) and other members of the company matrix (including
interaction with external vendors/CROs) for the day-to-day
oversight and conduction of the clinical studies included in the
"Book of Work" for the assets in the Immunology and Neurology
portfolios. Key Responsibilities
- Collaborates with the TA Medical Lead, CTL, Clinical Scientist
(CS), and Global Trial Manager (GTM) for the development of the
study protocol and ICF, authoring and providing medical input
during protocol development. Ensure the quality and accuracy of
study-related documents be submitted to relevant internal review
committees (including Protocol Review Committee/PRC and other
relevant governance groups).
- Contributes to and is a key member of a Clinical Trial Team
(CTT) associated with specific studies.
- Accountable for medical data review of trial data, including
eligibility assessment and interpretation of trial data
results.
- Holds responsibility for site interactions in partnership with
the Clinical Trial Leads (CTLs) for study-related medical questions
and education (including safety management guidelines). Provides
medical input into IRB and/or health authority protocol-specific
queries.
- Holds responsibility for assessment of key safety-related
serious adverse events in partnership with Worldwide Patient Safety
and oversees safety narratives (if applicable).
- Fulfills GCP and compliance obligations for clinical conduct
and maintains all required training.
- Provide medical oversight and accountability for the
study-related work conducted by external partners (CROs),
particularly related to medical monitoring-related activities.
- Partners with CTL and global Trial Manager (GTM) to support
executional delivery of studies (e.g., site activation, enrollment
status, as well as adjudication for protocol violations,
significant, non-significant deviations etc.).
- Provides continuous medical education in partnership with CTLs
and T/A Medical Leads related to protocol-specific training
(supporting the study team, investigators, CROs, and others).
- Provides medical expertise during Study Steering Committees,
Investigators' Meetings, and other study-related meetings with
external audiences.
- Helps to identify and build relationships with principal
investigators and other relevant external stakeholders.
- Maintains a strong medical/scientific reputation within
specific disease area(s).
- Authors/drafts clinical content for CSRs, regulatory documents,
and submissions (if applicable) to support closure, clinical
narratives, reporting and filling of the study in partnership with
CTLs. Qualifications / Experience
- MD required (or x-US equivalent).
- 2-3 years of clinical trial experience, either in industry or
academic setting; expertise in drug development process and
clinical research. Experience with implementation and conduction of
medical affairs-led studies desirable.
- Demonstrated track record of leadership in a complex, matrix
environment.
- Experience delivering successful results in a variety of
business situations.
- Ability to communicate information clearly and lead
presentations in scientific and clinical settings.
- Successful track record of leading through influence and
working across complex, global organizational matrices.
- Domestic and International travel may be required.#LI-HybridIf
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 adastaffingsupport@bms.com . Visit careers.bms.com/
eeo -accessibility 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.Any data processed in connection with role applications will
be treated in accordance with applicable data privacy policies and
regulations.
Keywords: Disability Solutions, Trenton , Clinical Trial Physician (CTP), Medical Evidence Generation - Neurology, Healthcare , Princeton, New Jersey
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