Senior Clinical Trial Physician, Immunology / Rheumatology

Job content

Working with UsChallenging. 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 / Objective

• Serves as a primary source of medical accountability and oversight for multiple clinical trials and across assets
• Manages Phase 1 – 3 studies, with demonstrated planning and decision making capabilities
• Provides medical and scientific expertise to cross-functional colleagues
• Matrix management responsibilities across internal and external networks

Position ResponsibilitiesMedical Monitoring

• Contributes to and is a key member of a high performing Study Team, and may be a member of the Clinical Development Team (CDT)
• Leads collaboration with CS and inputs into protocols and related study documents, providing medical oversight in protocol development
• Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and trainings (including safety management guidelines)
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Leads medical review of trial data, including top line results and full set of TLGs/TLFs
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

Clinical Development Expertise & Strategy

• In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
• Provides oversight and medical accountability for a group of studies across therapeutic indications
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS)
• Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
• Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
• Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others

Health Authority Interactions & Publications

• Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study

Degree RequirementsMD required (or ex-US equivalent)Subspecialty training in applicable therapeutic area (rheumatology, immunology, cell therapy) highly desiredExperience Requirements

• 5 or more years of industry or strong relevant scientific/medical experience in global clinical trials and drug development
• HA interactions and submission hands-on experience is an advantage

Key Competency Requirements

• Expertise in drug development process
• Expertise in the components needed to execute an effective clinical plan and protocols
• Expertise in scientific methods to test hypotheses, including statistical design, analysis, and interpretation of complex data
• Ability to communicate information clearly and lead presentations in scientific and clinical settings
• Proven ability to work effectively in matrix environment and across therapeutic indications and franchises

Travel RequiredDomestic and International travel may be requiredIf 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 CareersWith 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 ProtocolPhysical 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.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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.