Senior Clinical Scientist - Cell Therapy
- Employer
- Bristol Myers Squibb Company
- Location
- Summit East, NJ, United States
- Start date
- Sep 30, 2020
View more
- Discipline
- Clinical, Clinical Research, Science/R&D
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Job Title
Senior Clinical Scientist
Direct Manager
Clinical Scientist Program Lead, Ide-cel
Division
R&D / Global Drug Development
Location
Summit NJ
Direct Reports
N/A
Functional Area Description
The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Position Summary / Objective
- Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials
- Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
- Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
- Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members
- May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)
Position Responsibilities
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Plan and lead the implementation all study startup/conduct/close-out activities as applicable
- Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
- Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
- Site-facing activities such as training and serving as primary contact for clinical questions
- Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Clinical data trend identification; provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
Degree Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
Experience Requirements
- 5+ years of experience in clinical science, clinical research, or equivalent
- 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 skills
- Must be able to effectively communicate and collaborate across functions and job levels
- Ability to assimilate technical information quickly
- Routinely takes initiative
- Detail-oriented
- Strong sense of teamwork; ability to lead 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 cross-functional relationships
- 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 tools
Travel Required
Domestic and International travel may be required.
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.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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