Job Details
Scientific Manager, US Medical Affairs, Lymphoma
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving 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: careers.bms.com/working-with-us
Position Summary
The Scientific Manager is a member of the US Medical CAR T 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.
Support study team meetings in partnership with protocol manager; and collaborate with cross functional study team members.
Support various Medical cross-functional working groups with priority to activities related to CAR T
Key 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. 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.
Collaborate in the development of selected training materials for sites and medical field team and provide training for both external and internal stakeholders
Collaborate with Medical launch leads to define, guide and execute CAR T strategies and tactics with appropriate use of resources
Experience Requirements
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
Experience in clinical /translational research and/or medical affairs in hematology or oncology with 2+ years industry experience.
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
Ability to understand assigned protocol(s) and their requirements
Knowledge and skills to support study-specific data review, trend identification, data interpretation.
Intermediate medical writing skills and medical terminology
Basic planning/project management skills (develop short range plans that are realistic and effective)
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 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 (15%).
#LI-Hybrid
If you come across a role that intrigues you but doesn’t 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, Life-changing 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.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
COVID-19 Information
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.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.
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