Senior Clinical Trial Physician, Hematology
Company: Bristol Myers Squibb
Location: Somerville
Posted on: January 14, 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.The Sr. 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.
Experience RequiredMD required (or x-US equivalent) functional
assignment as Clinical Trial Physician3 or more years Industry
experience preferred with clinical trials requiredQualifications
DesiredSubspecialty training in oncology and/or hematology or
applicable therapeutic areaExpertise in using the scientific method
to test hypotheses, including statistical design, analysis, and
interpretationKnowledge of the drug development processKnowledge of
the components needed for an effective clinical plan and
protocolsStrong leadership skills with proven ability to lead and
work effectively in a team environmentExpected Areas of
CompetenceMatrix management responsibilities across the internal
and external networkManages Phase 1 --- Phase 3 studies, with
demonstrated decision making capabilitiesProvides medical and
scientific expertise to BMS colleagues in drug discovery, labeling,
regulatory, outcomes research, and marketing/commercial
departmentsAbility to present clearly in scientific and clinical
settingsClinical Development Studies and/or ProgramsContributes to
and is key member of a high performing Study Delivery Team (SDT)
and is a key member of the Clinical Development Team (CDT)Designs
and develops clinical plans and protocols with a strong strategic
focus based on knowledge of the asset/drug, disease area and
relevant science in order to meet regulatory and disease strategy
targets. Leads the analysis of benefit/risk for clinical
development protocols in a matrix team environment working in
partnership with Clinical Scientists (CS).Conducts medical data
review of trial data, including eligibility review.Responsible for
site interactions for medical questions and education (including
safety management guidelinesResponsible for assessment of key
safety-related serious adverse events in partnership with GPVE and
oversees safety narratives.Fulfills GCP and compliance obligations
for clinical conduct and maintains all required training for
sameClinical Development Expertise & StrategyCollaborates with CS
on protocols, providing medical strategic oversight in protocol
development (input on inclusion/exclusion criteria and other
safety-related clinical considerations); signs off on
protocol.Identifies and builds relationships with principal
investigators. Identifies and cultivates thought leaders (TLs) 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 via attendance
at 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 landscapeProvides
ongoing medical education in partnership with CS, protocol specific
training, to support study team, investigators, and others.Health
Authority Interactions & PublicationsContributes to key Health
Authority interactions and advisory board meetings as Clinical
Trial PhysicianAuthors/drafts clinical content for CSRs, regulatory
reports, briefing books and submission documents to support
closure, clinical narratives, reporting and filing of the study in
partnership with CSs.Reporting and Developmental ValueReports to
Clinical Development Lead (CDL)Broad experience in management of
and participation in functional and cross functional based matrix
teamsGain a broad perspective of the pharmaceutical development
process and the company's development strategyHands-on exposure in
the development and execution of clinical development plansAround
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.Full time
Keywords: Bristol Myers Squibb, Somerville , Senior Clinical Trial Physician, Hematology, Other , Somerville, Massachusetts
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