Company : Bristol Myers Squibb Location : Boudry Canton of Neuchâtel From : Neuvoo CH
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Position Summary The ClinicalTrialPhysician 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 clinicaltrials.
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 clinicaltrials 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 ClinicalTrialPhysician 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 clinicaltrials 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 Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen.
Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
BristolMyersSquibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld.
Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen. BristolMyersSquibb BoudryCanton of Neuchâtel
