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.Scope of Responsibility : Clinical development studies and / or programs : Contributes to and is key member of a high performing Study Delivery Team (SDT) and is a key member of the Clinical Development Team (CDT)Designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of the asset / drug, disease area and relevant science in order to meet regulatory and disease strategy targets.
Leads the analysis of benefit / risk for clinical development protocols in a matrix team environment working in partnership with Clinical Scientists (CS).
Conducts medical data review of trial data, including eligibility review.Responsible for site interactions for medical questions and education (including safety management guidelinesResponsible for assessment of key safety-related serious adverse events in partnership with GPVE and oversees safety narratives.
signs off on protocol.Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders (TLs) 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.
Keeps up-to-date in the disease area via attendance at 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 landscapeProvides ongoing medical education in partnership with CS, protocol specific training, to support study team, investigators, and others.
Health Authority interactions & publications : Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial PhysicianAuthors / drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filing of the study in partnership with CSs.
Reporting and Developmental Value : Reports to Clinical Development Lead (CDL)Broad experience in management of and participation in functional and cross functional based matrix teamsGain a broad perspective of the pharmaceutical development process and the company's development strategyHands-on exposure in the development and execution of clinical development plans.
Experience Required : MD required (or x-US equivalent) functional assignment as Clinical Trial PhysicianQualifications Desired : 3 or more years Industry experience with clinical trialsSub-specialty training in oncology and / or hematology or applicable therapeutic areaExpertise in using the scientific method to test hypotheses, including statistical design, analysis, and interpretationKnowledge of the drug development processKnowledge of the components needed for an effective clinical plan and protocolsStrong leadership skills with proven ability to lead and work effectively in a team environmentExpected Areas of Competence : Matrix management responsibilities across the internal and external networkManages Phase 1 Phase 3 studies, with demonstrated decision making capabilitiesProvides medical and scientific expertise to BMS colleagues in drug discovery, labelling, regulatory, outcomes research, and marketing / commercial departmentsAbility to present clearly in scientific and clinical settings.
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.
Job InfoType : Full timeLocation : Celgene - Boudry