Senior Clinical Scientist , Early Clinical Development - Hematology/Oncology & Cell Therapy
Company: Bristol Myers Squibb
Posted on: November 22, 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 implementation, planning, and execution of
assigned clinical trial activities.
- Successfully leads, plans, and executes trial level activities
for multiple trials with minimal to moderate level of
- Provides scientific and clinical leadership to clinical
scientists on study team (matrix leadership).
- May support clinical development planning in collaboration with
Early Clinical Development physician(s).Position Responsibilities:
- Maintain a thorough understanding of assigned protocols and
protocol requirements and educate team members.
- Plan and lead the implementation of clinical study
startup/conduct/close-out activities as applicable.
- Evaluate innovative trial designs in collaboration with the
- Manage protocol and ICF development process (e.g., documents
and amendments) with minimal guidance; includes writing, reviewing,
adjudication/resolution of cross functional comments and ensuring
high clinical quality in collaboration with Medical Writing.
Present to governance committee and early clinical development team
meetings as required.
- Serve as primary contact for site-facing activities such as
training and support for clinical questions.
- Conduct and oversee activities related to data generation and
validation, including CRF design, clinical data review/query
resolution; ensure consistent, quality data review.
- Identify clinical data trends; provide trends and escalate
questions to study physician.
- Develop clinical narrative plan and review clinical
- Provide information required by Protocol Manager for
development of trial budget, CRO scope of work, etc.
- Review/develop site and CRA training materials and presentation
at SIV and Investigator meetings and support on Study committee
(e.g., safety review) activities.
- Author/review clinical study reports (CSRs) and clinical
portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR,
- Collaborate and serve as primary liaison between external
partners for scientific advice.
- Author/review abstracts, presentations, and manuscripts for
external publications Degree Requirements:
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar
scientific field preferred).Experience Requirements:
- 5+ years of experience in clinical science, clinical research,
- Proficient knowledge of GCP/ICH, drug development process,
study design, statistics, clinical operations.
- Proficient knowledge and skills to support program specific
data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring
committees, dose review teams, and independent response
adjudication committees.Key Competency Requirements:
- Excellent verbal, written, communication and interpersonal
- Must be able to effectively communicate and collaborate across
functions and job levels.
- Ability to assimilate technical information quickly.
- Routinely takes initiative.
- Strong sense of teamwork; ability to lead matrix team
- Proficient in Medical Terminology and medical writing
- Proficient knowledge of the disease area(s), KOLs,
indication(s), compound(s) under study (including MOA, PK/PD,
biomarker & safety profile).
- Proficient critical thinking, problem solving, decision making
- Understanding of functional and cross-functional
- Commitment to Quality.
- Adaptable / Flexible - willing and able to adjust to multiple
demands and shifting priorities as well as an ability to meet
day-to-day challenges with confidence and professionalism.
- Proficient planning/project management skills (ability to
develop short to mid-range plans that are realistic and effective
in meeting goals).
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic
Data Capture (e.g., RAVE), J-Review or similar data reporting
- 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 lives.
Physical presence at the BMS worksite or physical presence in the
field is an essential job function of this role which the Company
deems critical to collaboration, innovation, productivity, employee
well-being and engagement, and enhances the Company culture.To
protect the safety of our workforce, customers, patients and
communities, the policy of the Company requires all employees and
workers in the U.S. and Puerto Rico to be fully vaccinated against
COVID-19, unless they have received an exception based on an
approved request for a medical or religious reasonable
accommodation. Therefore, all BMS applicants seeking a role located
in the U.S. and Puerto Rico must confirm that they have already
received or are willing to receive the full COVID-19 vaccination by
their start date as a qualification of the role and condition of
employment. This requirement is subject to state and local law
restrictions and may not be applicable to employees working in
certain jurisdictions such as Montana. This requirement is also
subject to discussions with collective bargaining representatives
in the U.S.Our company is committed to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace adjustments and ongoing support in their
roles. Applicants can request an approval of accommodation prior to
accepting a job offer. If you require reasonable accommodation in
completing this application or if you are applying to a role based
in the U.S. or Puerto Rico and you believe that you are unable to
receive a COVID-19 vaccine due to a medical condition or sincerely
held religious belief, during or any part of the recruitment
process, please direct your inquiries to . Visit to access our
complete Equal Employment Opportunity statement. 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
Keywords: Bristol Myers Squibb, Cambridge , Senior Clinical Scientist , Early Clinical Development - Hematology/Oncology & Cell Therapy, Healthcare , Cambridge, Massachusetts
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