Clinical Trial Physician (CTP), Medical Evidence Generation
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:
.Position Summary The Clinical Trial Physician (CTP) in the
Worldwide Medical Evidence Generation (MEG) group will serve as the
primary source of medical/clinical accountability and day-to-day
oversight and conduction of the Evidence Generation Book of Work
(BoW), including medical affairs-led sponsored studies
(interventional and non-interventional), Investigators Sponsored
Studies (ISRs) and Clinical Research Collaborations (CRCs), in
alignment with the Integrated Evidence Plans for the assets in the
company's portfolio. He/she will lead and participate in
cross-functional matrix leadership teams (including external
vendors/CROs) focused on building these relationships and actively
sourcing research concepts that address evidence gaps for
prioritized early and late assets. The CTP is also responsible to
co-lead the Evidence Generation Plan.Key Responsibilities
- Drive the cardiovascular MEG Book of Work ensuring they are on
strategy and executed with rigor and on time and in close
collaboration with Global Development Operations (GDO), Worldwide
Medical (WWM), Health Economics Outcomes Research (HEOR), among
other stakeholders.
- Partner with the WWM-CV organization to co-develop the
Integrated Evidence Generation Plan and lead the Evidence
Generation Working Group (EGWG).
- Collaborates with the TA Medical Lead, CTL, Clinical Scientist
(CS), and Global Trial Manager (GTM) for the development of the
study concept, study protocol and ICF, authoring and providing
medical input during protocol development. Ensure the quality and
accuracy of study-related documents are 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 the Clinical Trial Lead (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 Therapeutic Area 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.
- Employ strong business acumen and fiscal stewardship focused on
driving reciprocal scientific value creation and allocate resources
consistent with company priorities. Qualifications & Experience
- MD required (or x-US equivalent).
- 2-3 years of clinical trial experience, either in industry or
an academic setting; expertise in the 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 is required. Key Competency
Requirements
- Demonstrated ability to strategically analyze data generation
opportunities with minimal supervision.
- Demonstrated ability to develop and sustain high-performing
relationships with external thought leaders and internal matrix
stakeholders.
- Adeptness at building credibility with external investigators
and collaborative partners competently balancing business and
scientific acumen complemented by strong leadership behaviors,
authenticity, agility, and an enterprise mindset.
- Understanding of global healthcare systems and academic
settings with a demonstrated ability to lead in an ambiguous and
changing healthcare/business environments.
- Exceptional communication and interpersonal skills to influence
decision-making at all levels of the organization.
- In depth knowledge of overall project planning and project
management of clinical trials.
- Proven ability to partner effectively with colleagues across
multiple functions and at all levels of the enterprise.
- Exceptional interpersonal and communication skills
appropriately flexing based on audience; expertly leverages
effective communication and negotiation skills to influence
decisions.
- 30% expected travel globally.#LI-Hybrid 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, Scranton , Clinical Trial Physician (CTP), Medical Evidence Generation, Healthcare , Princeton, Pennsylvania
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