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.
At Bristol-Myers Squibb, we're creating innovative medicines for patients who are fighting serious diseases. We're also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.
Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skill sets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team. In this role, you will be responsible for (but not limited to):
Clinical development studies and/or programs:
- Contribute to and being a key member of a high performing Study Delivery Team (SDT) and a key member of the Clinical Development Team (CDT)
- Design and develop 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. You l ead the analysis of benefit/risk for clinical development protocols in a matrix team environment working in partnership with Clinical Scientists (CS).
- Conduct 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 .
- Fulfill GCP and compliance obligations for clinical conduct and maintains all required training for same
Clinical development expertise & strategy:
- Collaborate with CS on protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations); sign off on protocol.
- Identify and build relationships with principal investigators. Identify and cultivate 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.
- Maintain a strong medical/scientific reputation within the disease area. You have in depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. You keep up-to-date in the disease area via attendance at scientific conferences and ongoing review of the literature.
- Keep abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
- Provide ongoing medical education in partnership with CS, protocol specific training, to support study team, investigators, and others.
Health Authority interactions & publications :
- Contribute to key Health Authority interactions and advisory board meetings as Clinical Trial Physician
- Author/draft 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
- Gain a broad perspective of the pharmaceutical development process and the company's development strategy
- Master Degree in Sciences or relevant field
- At least 4 years experience within the industry with clinical trials or similar experience
- Subspecialty training in oncology and/or hematology or applicable therapeutic area
- Proven first experience in Managing Phase 1 - Phase 3 studies , with demonstrated decision making capabilities
- Strong medical and scientific expertise in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial department
- Expertise in using the scientific method to test hypotheses, including statistical design, analysis, and interpretation
- Ability to present clearly in scientific and clinical settings
- Fluency in both English & French
- At ease on working in Matrix and international environment
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.