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The Senior Clinical Trial Physician role is in the Immunology/Fibrosis therapeutic area. This position sites within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development programs. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
o Provides medical and scientific expertise to cross-functional BMS colleagues
o Matrix management responsibilities across the internal and external network
o Serves as a primary source of medical accountability and oversight for multiple clinical trials
o Manages Phase 1 Phase 3 studies, with demonstrated decision making capabilities
Clinical Development Expertise & Strategy
o In collaboration with the Clinical Development Lead and/or Clinical Development Team Lead, designs and develops clinical development 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
o Provides oversight and medical accountability for a group of studies
o Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS)
o 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.)
o 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
o 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
o 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
o Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
Medical Monitoring
o Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)
o Leads medical data review of trial data, including eligibility review
o Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
o Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
o Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
o Fulfills good clinical practice (GCP) and compliance obligations for clinical conduct and maintains all required training
Health Authority Interactions and Publications
o Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Senior Clinical Trial Physician
o Authors/drafts clinical content for clinical study reports (CSRs), regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with CSs
Requirements:
o MD required (or ex-US equivalent); PhD or substantial academic research experience preferable
o Subspecialty training in rheumatology, gastroenterology, immunology, or related fields preferable
o Interest in strategic approaches to early clinical development preferable
o 5 or more years of Industry experience and/or clinical trials experience is preferred
Key Competency Requirements:
o A critical mindset is deemed essential for this position
o Ability to communicate information clearly and lead presentations in scientific and clinical settings
o Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
o Familiarity with the drug development process
o Expertise in the components needed to execute an effective clinical plan and protocols
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.
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.