Bristol-Myers Squibb Company
Summit, NJ, United States
Healthcare, Clinical Research, Pharmaceutical
Aug 03, 2020
Nov 16, 2020
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.
MD required (or x-US equivalent) functional assignment as Clinical Trial Physician
Sub-specialty training in oncology and/or hematology or applicable therapeutic area
3 or more years Industry experience with clinical trials required
Expertise in using the scientific method to test hypotheses, including statistical design, analysis, and interpretation
Knowledge of the drug development process
Knowledge of the components needed for an effective clinical plan and protocols
Strong leadership skills with proven ability to lead and work effectively in a team environment
Expected Areas of Competence:
Matrix management responsibilities across the internal and external network
Manages Phase 1 - Phase 3 studies , with demonstrated decision making capabilities
Provides medical and scientific expertise to BMS colleagues in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial departments
Ability to present clearly in scientific and clinical settings
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 guidelines
Responsible for assessment of key safety-related serious adverse events in partnership with GPVE and oversees safety narratives .
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training for same
Clinical development expertise & strategy:
Collaborates with CS on protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations); 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 landscape
Provides 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 Physician
Authors/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 teams
Gain a broad perspective of the pharmaceutical development process and the company's development strategy
Hands-on exposure in the development and execution of clinical development plans
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.
Company: Bristol-Myers Squibb
Req Number: R1528222_EN
Updated: 2020-08-03 00:00:00.000 UTC
Location: Summit,New Jersey
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Bristol-Myers Squibb Company
Website : http://www.bms.com