Risk Management Lead
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.
About Bristol-Myers Squibb:
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
This role will report to a Head of Clinical Trial Risk Management, who serves as a member of the Global Clinical Compliance & Clinical Trial Risk Management leadership team under Global Clinical Compliance & Continuous Improvement (GCC&CI) organization.
The role assists in enabling corporate and R&D objectives and supports Quality by Design principles by collaborating to establish, maintain and operationalize a framework for Clinical Risk Management, in partnership with stakeholders across R&D and Global Quality. Responsibilities will include:
- Collaborate with the study teams and help implement Quality by Design from protocol development and study startup, to database lock, and data analysis to ensure appropriate cross-functional coordination of risk assessment and management throughout the duration of Clinical Trials.
- Facilitate relevant discussions with the study Risk Team (i.e. team responsible for the Risk Assessment and Categorization Tool [RACT]), while working closely with all functions involved to assure alignment on the Quality Threshold Limits (QTLs) and the Risk-Based approach to monitoring with proper documentation of actions and accountabilities.
- During the identification of potential clinical external partners (Contract Research Organizations, specialty labs, etc.), work on the technical assessment as part of the due diligence process, to determine Quality and Compliance capabilities and health of the Quality Management System of the potential partner. Work closely with the Clinical Trial Planning and Alliance Management team as well as the Global Quality organization to develop appropriate Quality Agreements and Quality Oversight management plans with partners. Assist/Support day-to-day vendor oversight and ensure appropriate documentation of such.
- Perform ongoing assessment of the effectiveness of the Risk Mitigation activities and escalate to the right level of Governance as needed.
- Support clinical study teams to be inspection ready at all times. Coordinate Inspection Preparedness efforts and support sponsor audits and inspections in partnership with Global Quality.
- Serve as Corrective Action Preventive Action (CAPA) lead and support individual CAPA owners to conduct root-cause analyses, develop mitigation plans, and implement CAPAs within prescribed deadlines. Advise the Clinical Training, Process and Continuous Improvement team as to training needs and provide input into Quality Improvement Plans.
- Advise the Clinical Training, Process and Continuous Improvement team as to training needs and provide input into Quality Improvement Plans.
- Work with management and Global Quality to foster a cross functional mindset Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.
A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years in the pharmaceutical industry and 2 years of experience in clinical trial operations and/or Good Clinical Practice is required.
- Robust understanding of the drug development process and clinical trial execution, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions.
- Experience with the RACT and Risk-Based Monitoring principles, experience with eTMF, Veeva systems, Clinical Trial Management Systems and other quality systems is preferred.
- Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities). Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner.
- Experience in Project Management is a plus in the context of Inspection Preparedness.
- Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.
- The candidate will demonstrate the ability to adopt a biopharma enterprise wide and entrepreneurial mindset, to act with speed, accountability and integrity.
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.