Risk Management Framework Lead
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 the Director of Quality Clinical Compliance and Risk Management who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI) leadership team under Global Clinical Operations (GCO). Responsibilities will include:
- Support management in establishing and coordinating the GCO Quality and Compliance Governance Council, in partnership with Global Quality. The scope of this governance is Good Clinical Practice (GCP) with a clear focus on Clinical Operations. Work with various internal support functions to establish risk management metrics and scorecards to be presented to the governance.
- Develop, implement and maintain a GCO-wide, end-to-end Risk Management Framework to enable simplified risk identification, categorization, mitigation and escalation as appropriate. Work closely with Global Quality, Training Process and Continuous Improvement, and Regional Clinical Compliance to ensure that country and study teams have the appropriate knowledge and training to handle risk at the site and country level, including Corrective Action Preventive Action (CAPA) plans.
- Ensure that identified risk is appropriately documented in central repository and escalated to the right level of governance. Work with internal support functions to establish a framework for the repository and analysis of clinical risk, analyze metrics and trends at the study, asset and program levels.
- Provide expertise and advice to Risk Management Leads, Data Managers, etc, to ensure that risk management is done consistently across clinical trials, and that systemic issues are identified and mitigated. Provide additional support to Risk Management Leads and Regional Clinical Compliance in case of major audits and inspections or when systemic issues are identified.
- Support the Risk Management Leads on the technical assessment of external partners as part of the due diligence process and in developing consistent Quality Oversight management plans with partners. Help measure vendor performance by developing/enhancing tracking and reporting tools and provide framework for documentation of oversight.
- Keep abreast of the changing regulatory landscape and externally engage as appropriate with industry consortia.
- 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 regional, cross functional mindset of 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 operations, 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, CTMS (Seibel) and other quality systems is required.
- 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.
- 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, and to have fun along the way.