Senior Clinical Scientist, Medical Evidence Generation (MEG), Medical Affairs, Hematology
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 is a member of the Medical Evidence Generation (MEG) team which provides scientific expertise necessary to design and deliver the company-sponsored, medical-led clinical trials.
Responsible for implementation, planning, and scientific execution of assigned clinical trial activities. Work closely with other clinical team members within the assigned project to execute activities associated with the conduct.
Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.
Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members.
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. Collaborate and liaise with external partners (e.g., KOLs, CROs).
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 the assigned Medical Writer). Present these documents to governance committees as required. Ensure CRF design adequately supports data collection in alignment with the protocol (in collaboration with Data Management and Programming teams).
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 (if applicable).
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), if applicable.
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.
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
Knowledge and skills to support study-specific data review, trend identification, data interpretation.
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 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.
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.
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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