Associate Director, Business Risk Management and Compliance

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.

R1595650 Associate Director, Business Risk Management and Compliance

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

: Up to 30% domestic and international travel may be required.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Bristol Myers Squibb is Disability Confident – Employer

A UK Government scheme

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.