Clinical Development Lead, Hematology
Company: Bristol-Myers Squibb
Location: Toms River
Posted on: February 22, 2021
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Job Description:
At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients' lives through science.--In oncology,
hematology, immunology and cardiovascular disease - and one of the
most diverse and promising pipelines in the industry - each of our
passionate colleagues contribute to innovations that drive
meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference. Summary Clinical
Development is a global organization dedicated to the efficient
design and execution of innovative drug development clinical
programs that deliver meaningful new treatment options to patients.
Clinical Development drives clinical development strategy, design,
execution, and interpretation of clinical trials through the
combination of strong scientific and clinical expertise and
strategic leadership to ensure safe and effective use of BMS
products. A CDL is a scientific and clinical leader who serves as
the clinical point of accountability of the Development Team and
responsible for the overall clinical development plan for an asset
or assets in one or more indications/tumor types. Integrates input
from Clinical Trial Physicians (CTPs), Clinical Scientists (CSs),
statistics, regulatory, operations, safety, outcomes research,
medical, commercial, translational medicine, and other experts both
internal and external to BMS. Ensures that studies are aligned with
target label indications and are properly designed and conducted to
meet regulatory, quality, medical and access goals. CDLs are matrix
leaders and managers who lead, develop, motivate and achieve
results through teams; demonstrate a commitment to the development
of a resilient attitude, embrace change and have an unwavering
commitment to our People Strategy. Responsibilities Serves as a
manager to Clinical Trial Physicians (CTPs) Serves as the Primary
Clinical representative for the relevant asset and/or indication(s)
on the Development Teams. Is expected to be able to represent
Clinical Development in both internal and external forums as the
consulted authority for the disease area, including within BD
function. Partner pro-actively with the Clinical Scientists, Early
Clinical Program Leads as well as other GDD Clinical Development
Leads. Accountable for the clinical contribution to the development
of each indication strategy, including registrational and
non-registrational studies, with the support of the CTPs and CSs
within the asset and/or indication. Responsible for managing
clinical trial physician(s); attracting, developing and retaining
top talent; ensuring appropriate training and mentoring of clinical
trial physicians. May serve as CTP as necessary Accountable in
partnership with the Clinical Scientist for the design, execution,
and analyses of each study led by the CTPs and CSs. Accountable for
clinical content for CSRs, regulatory reports, briefing books and
submission documents. Champions a quality-focused mindset and
ensures adherence to GCP and compliance obligations for clinical
conduct Partners with GPV&E physicians in the ongoing review of
safety data. Serves as the (co-)leader of the cross-functional
Clinical Development Team. Provides clinical leadership and disease
area expertise into integrated disease area strategies. Partners
closely with KOLs in specific indications., Serves as Primary
Clinical Representative in Regulatory interactions. Evaluates
strategic options against a given Target Product Profile (TPP)
Collaborates with GCO/Global Compliance Group to develop asset
level risk management plan, resolves issues with Quality/CS, and
raises to DT as needed Sets executional priorities and partners
with CTP and CS to support executional delivery of studies
Accountable for top line data with support of CTP, CS, and
Statisticians Degree Requirements MD preferably with appropriate
sub-specialty training as appropriate; PhD, Pharm D or other health
related scientific field with a deep understanding of the clinical
principles of the area of interest or equivalent therapy area
knowledge. At least 9 years of relevant experience. Experience
Requirements CDL has demonstrated leadership in the design and
execution of multiple clinical trials (e.g. significant experience
as a senior clinical leader), and exhibits all of the following
attributes: Able to synthesize internal and external data to
produce a clinical strategy. Able to ensure that the clinical
program will result in a viable registrational strategy. Able to
assess personnel needs, translate into a hiring strategy, and lead
the hiring efforts. Able to work with other stakeholders to ensure
a robust enterprise level strategy for asset(s) and indication(s)
including early, late and post-marketing development, as well as
awareness of the enterprise disease area portfolio. CDL has
demonstrated sustained excellent performance as Clinical Trial
Physician, Clinical Scientist, or equivalent. Verifiable track
record of successful people management and development, or
leadership in a matrix team (e.g. mentoring junior colleagues). Key
Competency Requirements CDL has demonstrated excellent skills in
Clinical development strategy including the clinical components of
regulatory submission(s) External focus to understand the trends in
the disease area treatment paradigms and ability to build
relationships with external partners, thought leaders and
collaborators outside of BMS Partner and interact with colleagues
from Early Development who design and implement first in human
through proof of concept trials and will to assure a seamless
transition into late stage development (Phase II-III trials)
Ability to lead and develop a group of CTPs to ensure scientific
and technical excellence of clinical development programs and
deliverables. Travel Required Domestic & International travel may
be required / occasionally Around the world, we are passionate
about making an impact on the lives of patients with serious
diseases. Empowered to apply our individual talents and diverse
perspectives in an inclusive culture, our shared values of passion,
innovation, urgency, accountability, inclusion and integrity bring
out the highest potential of each of our colleagues. 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. W
e're creatinginnovative medicines for patients fighting serious
diseases. We're also nurturing our own diverse team with inspiring
work and challenging career options. No matter the role, each one
of us makes a contribution. And that makes all the difference.
Keywords: Bristol-Myers Squibb, Brick , Clinical Development Lead, Hematology, Healthcare , Toms River, New Jersey
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