Associate Director, Business Risk Management and Compliance in Uxbridge

Working with Us: Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Position Purpose

Member of the Trial Risk and Integrity Management (TRIM) department within Trial Delivery Support. Responsible for executing a comprehensive and integrated Quality Risk Management (QRM) program across clinical operations, with a focus on Good Clinical Practice (GCP) guideline compliance. Responsible for identifying and mitigating emerging business risks using advanced risk assessment principles and methodologies, including quality and performance analytics, for thorough mitigation, continuous monitoring and oversight. Foster and promote a culture of Quality Excellence and Inspection Readiness, building risk awareness and demonstrating business value of proactive, predictive risk management across teams in a multifunctional, matrixed manner. Partner within the broader BMS Risk Governance structure and will collaborate with R&D Quality (Risk Governance and Operations) and applicable GDO & TA functions, including RCO and Regional Clinical Compliance, to deliver end-to-end Business Risk Management to ensure the biggest threats to GDO objectives are prioritized and mitigated.

Key Responsibilities

• Executing a robust, comprehensive and integrated quality risk management (QRM) program that addresses areas of business risk.
• Fosters a global, cross-functional Quality Excellence and Inspection Readiness mindset at all times.
• Promotes a high-Quality Culture standard and framework by embedding risk management principles and demonstrating business benefits to partners and peers.
• Responsible for monitoring GDO performance by assessment of compliance and quality trends, using QMS and associated system and platform datasets.
• Data specialist with fluency in clinical data analytics, interpretation and trend discovery to support evidence-based decision-making and continuous performance monitoring.
• Risk Management specialist, applying advanced principles and techniques to proactively identify, assess, and mitigate risks across clinical operations.
• Responsible for assigning priority and escalating risks as appropriate.
• Responsible for maintaining functional Risk Oversight, monitoring the delivery of mitigation Actions, with Effectiveness checking.
• Responsible for developing and executing business risk management strategies to support and supplement alternative Inspection Readiness efforts, including the global auditing program and within-business programs and projects (proactive Compliance Assessments, Quality Control, Issue Management, etc.).
• Drives end-to-end Risk Management at the appropriate level by ensuring connection and escalation of emerging signals and potential risks by Scope, e.g. Process (global, local); Program and Study; Region, Country and Cluster; Category and Supplier; and Investigator and Site for thorough consultation, risk assessment, and effective mitigations.
• Takes leadership or participates in Continuous Improvement projects to identify and enable process improvements.
• Supports the strategic direction of Risk Based Management within the business to include leadership of RBM innovation, education and embedding.
• Provides Coaching, mentorship and aids in the development of onboarders or new team members.
• Takes on additional responsibilities as directed by leadership.

Knowledge, Skills & Experience

• 8 plus years of relevant industry experience, in clinical trial operations and/or GCP is required.
• Extensive global clinical trial expertise with a proven track record of leading through influence and effectively navigating complex, global organizational matrices.
• Demonstrate the ability (or potential) to lead and manage teams, provide clear direction, support, and motivation to achieve departmental and organizational goals.
• Experience in matrix management and training, demonstrating leadership ability (or potential), including inspiring, motivating, and guiding colleagues or cross-functional teams to achieve their best performance.
• Excellent communication skills with a demonstrated ability to effectively engage, manage, and influence key internal stakeholders across various functions and geographies, as well as external stakeholders, including Health Authorities.
• Excellent presentation and negotiation skills, with the ability to resolve conflicts constructively and in a timely manner within cross-functional teams.
• Proven ability to manage multiple projects simultaneously, ensuring timely execution of tasks. Attention to detail, with excellent planning, time management, and organizational skills.
• Ability to drive and manage issue escalation effectively, ensuring swift resolution, with a capability and record of managing conflict.
• Strategic mindset to recognize and translate business process needs across varying scopes and levels, for effective process development, improvement and implementation.
• Demonstrates an enterprise-wide and entrepreneurial mindset, acting with speed, accountability, and integrity, while fostering a positive and enjoyable work environment.
• Proficient in data and statistical analyses and interpretation, using data visualizations to derive meaningful insights, capable of clearly communicating the outcomes (including risks) to audiences with varying levels of understanding.
• Well-versed in industry trends and emerging dynamics concerning clinical trial processes and data collection, ensuring the organization remains at the forefront of industry standards.
• Demonstrated expertise in Risk Management in a regulated industry, with a strong emphasis on GCP, Quality and Operations.
• Keeps abreast of new regulations and standards and able to adapt and recommend/promote necessary changes in WoW.

Qualifications

• Bachelor's degree (or equivalent degree) is required; a degree in a life science (or equivalent) is preferred.
• Priority given to Advanced degrees.
• Additional Requirements: Travel up to 30% domestic and international travel may be required.