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Job Details


Bristol-Meyers Squibb, Co.

Clinical Trial Physician - Rheumatology (R1559828-en-us)

Pharmaceuticals

All

Yearly

No

Princeton, New Jersey, United States

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.

Position Summary

The Clinical Trial Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.

  • Manages data review and quality of Phase 1 – Phase 3 studies, with demonstrated analytical and decision-making capabilities
  • Serves as a primary source of medical accountability and oversight for clinical trials
  • Matrix management responsibilities across the internal and external network
  • Provides medical and scientific expertise to cross-functional BMS colleagues

Key Responsibilities

Clinical Data Review and Oversight for Immunologic/ Rheumatologic Indications

  • Leads eligibility and clinical efficacy data review and monitoring activities across one or more studies/indications
  • Delivery and development of indication- and study-specific trainings
  • Manages site interactions for medical questions and education related to protocol-specific eligibility and ongoing efficacy assessments
  • Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

Medical Monitoring

  • 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)
  • Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (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
  • Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)

Clinical Development Expertise & Strategy

  • In collaboration with the Clinical Development Lead, may design and develop 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
  • Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
  • 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 and site personnel. 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 knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date 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 CS to allow for protocol-specific training, supporting the study team, investigators, and others

Health Authority Interactions & Publications

  • Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician
  • Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists

Qualifications & Experience

  • MD/DO required (or ex-US equivalent)
  • 3 or more years of clinical experience and/or clinical trials experience (within industry/CRO or academia as investigator) required
  • Experience in clinical data review, analysis and interpretation/integration required
  • Ability to communicate and present information clearly in scientific and clinical settings
  • Subspecialty training or experience in immunology therapeutic area, especially SLE, is highly desired
  • Knowledge of global drug development and the components needed to execute an effective clinical plan and protocols

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.