Senior Clinical Scientist - Cell Therapy (R1558969-en-us)
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 Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.
Responsible for implementation, planning, and execution of assigned clinical trial activities.
May serve 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 Clinical Operations; 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)
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 in safety and/or efficacy; 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
Support 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 in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
5+ years of experience in clinical science, clinical research, or equivalent
Hematology/Oncology experience (Cell Therapy preferred but not required) in clinical research and development, in a clinical science capacity, ie not laboratory or bench science
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
Familiarity with Medidata, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings)
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
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 in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review, Spotfire or similar data reporting/review tools (e.g., patient profiles, listings)
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.
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