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.
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
- Provide strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs
- Independently lead complex, large, global in-house or outsourced, Registrational Data Generating trials/studies in Cell Therapy at any point in the life cycle of the trial/study (i.e. start up, maintenance, or close-out)
- Act as the primary operational contact for the study and leads the cross- functional global team for execution of the study
- May provide operational leadership of one or more cross-functional Study Team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors
- Have high global organizational impact and influence, and significant impact on function and Study Team
- Direct and delegate to the assigned Global Trial Management Staff as applicable
- Drive study execution utilizing available performance metrics and quality indicators and study milestones and drivers
- Oversee clinical monitoring quality and adherence to established processes and plans
- Develop, manage, and maintain study deliverables (i.e. timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions
- Maintain/update data as appropriate in project management tools including CTMS
- Lead, develop, and implement cross-functional/global initiatives and best practices
- Collaborate with CSO on global investigational product [IP] supply forecasting/management
- Participate in the subject recruitment/retention strategy and related initiatives (e.g. recruitment material)...
- Proactively develop and maintain collaborative relationships with internal partners/stakeholders across the multidisciplinary teams
- Bachelor or Master in Sciences
- Minimum 6 years of clinical study management experience in direct multinational study management
- Previous experience in Cell Therapy / Oncology
- Experience in leading global clinical trials
- Demonstrated project management and organizational skills with strong presentation and communication abilities.
- Experience with electronic quality, compliance and CTMS systems
- Experience in managing CROs experience is a plus
- Expert knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and Clinical Trial Process (CTP).
- You have proven skills in leadership/influence and negotiating management skills
- You have critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines
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.