Clinical Scientist, Early Clinical Development - Hematology/Oncology & Cell Therapy
Company: Bristol Myers Squibb
Posted on: June 23, 2022
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 Early Clinical
Development (ECD-HOCT) team at BMS is responsible for hematology,
oncology and cell therapy pipeline assets and sits at the interface
between discovery and translational science and clinical drug
development. Composed of physician-scientists and
clinical-scientists, this group oversees the early development of
both internal and partnered assets covering all platforms of
therapies, including small molecules, traditional and complex
biologics and next gen cell therapies. Therapeutic areas span the
full range of hematologic and solid tumor indications. The ECD-HOCT
team interacts hand-in-glove with discovery and translational
scientists, project leadership, late development and commercial
colleagues to optimize biomarker, patient enrichment, dosing and
combination strategies to enable faster and more effective drug
development informed by core scientific principals and
data.Functional Area DescriptionThe Early Development Clinical
Scientist function provides scientific expertise necessary to
design and deliver clinical studies and programs.Position
- Responsible for design and execution of assigned clinical trial
activities and works closely with clinical team members to execute
activities associated with trial conduct.
- May lead or support trial level activities for one or more
trials with the necessary supervision.Position Responsibilities:
- Collaborate and liaise with external partners (e.g.,
- Seek out and enact best practices with instruction.
- Provide regular and timely updates to manager/management as
- Collaborate cross-functionally to develop Protocol and ICF
documents / amendments and present these to governance committee
and early clinical development team meetings as required.
- Conduct literature review.
- Develop site and CRA training materials and present these at
SIVs and Investigator meetings.
- Review clinical narratives.
- Collaborate cross-functionally to monitor clinical data for
- Contribute to the development of Data Review Plan in
collaboration with Data Management.
- Ensure CRF design adequately supports data collection in
alignment with the protocol in collaboration with Data
- Author/review clinical contributions to clinical study reports
(CSRs) and clinical portions of Regulatory Documents (e.g.,
Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB
responses and contribute to regulatory submission.)
- Submit clinical documents to TMF.
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar
scientific field preferred).Experience Requirements:
- Expectation of 2+ years of experience in clinical science,
clinical research, or equivalent, hematology and oncology prior
- Proficient knowledge of GCP/ICH, drug development process,
study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their
- Knowledge and skills to support program-specific data review
and trend identification.
- Intermediate medical writing skills and medical
- Basic knowledge of the establishment and operation of data
monitoring committees, dose review teams, and independent response
adjudication committees.Key Competency Requirements:
- Basic planning/project management skills (develop short range
plans that are realistic and effective)
- Basic knowledge of disease area, compound, current clinical
- Detail-oriented with commitment to quality
- Intermediate critical thinking and problem-solving skills.
- Adaptable / flexible (willing and able to adjust to multiple
demands and shifting priorities; ability to meet day-to-day
challenges with confidence and professionalism)
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data
review tools (e.g., patient profiles, report generating tools)
- Domestic and international travel may be required
(approximately 10-20%)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
Keywords: Bristol Myers Squibb, Trenton , Clinical Scientist, Early Clinical Development - Hematology/Oncology & Cell Therapy, Healthcare , Princeton, New Jersey
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