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.
For our Team in Boudry and to work closely with our USA Colleagues, you would be mainly responsible for
- Implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials
- Successfully leading plans, and executing trial level activities for multiple trials with minimal to moderate level of supervision
- Providing scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
- Co-Leading study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members
- May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)
- Maintaining a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Planning and leading the implementation all study startup/conduct/close-out activities as applicable
- Evaluating innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
- Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
- Site-facing activities such as training and serving as primary contact for clinical questions
- Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Clinical data trend identification; provide trends and escalate questions to Medical Monitor
- Developing clinical narrative plan; reviewing clinical narratives
- Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Reviewing development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Drafting/reviewing and validating clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
- 5+ years of experience in clinical science, clinical research, or equivalent
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Excellent verbal, written, communication and interpersonal skills in Englis
- Ability to assimilate technical information quickly
- You are detail-oriented and have a strong sense of teamwork; ability to lead team activities
- Proficient in Medical Terminology and medical writing skills
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
- Proficient critical thinking, problem solving, decision making skills
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.