Clinical Scientist Early Clinical Development ImmunologyCardiovascularNeuroscience
Clinical Scientist Early Clinical Development ImmunologyCardiovascularNeuroscience
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1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving 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: Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. This role supports the Immunology Cardiovascular Fibrosis and Neuroscience team.
Position Summary / Objective
Responsible for implementation planning and of assigned clinical trial activities.
Successfully leads plans and executes trial level activities for multiple trials with minimal to moderate level of supervision.
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/closeout activities as applicable.
Evaluate innovative trial designs in collaboration with the study physician.
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 sitefacing 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 narratives.
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. preIND IND IB DSUR regulatory responses).
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
1 years experience in clinical science and clinical research
Proficient hands on knowledge and experience in clinical development process
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.
Preferred Experience:
Experience in Early Clinical Development designing and implementing all facets of early clinical studies
Key Competency Requirements
Excellent verbal written communication and interpersonal skills.
Must be able to effectively communicate and collaborate across functions and job levels.
Ability to assimilate technical information quickly.
Routinely takes initiative.
Detailoriented.
Strong sense of teamwork; ability to lead matrix team activities.
Proficient in Medical Terminology and medical writing skills.
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 skills.
Understanding of functional and crossfunctional relationships.
Commitment to Quality.
Adaptable / Flexible willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet daytoday challenges with confidence and professionalism.
Proficient planning/project management skills (ability to develop short to midrange plans that are realistic and effective in meeting goals).
Proficient in Microsoft Word Excel PowerPoint Electronic Data Capture (e.g. RAVE) JReview or similar data reporting tools.
#LIHybrid
If you come across a role that intrigues you but doesnt 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 Lifechanging Careers
With 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.
Onsite Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Employment Type
Full-Time
