Overview

Working with Us. We offer challenging, meaningful work with opportunities to grow. Bristol Myers Squibb supports balance and flexibility with competitive benefits and programs to help employees pursue goals at work and in their personal lives. For more information, visit the careers site.

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.
• Identify and mitigate 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 the business value of proactive, predictive risk management across teams in a multifunctional, matrixed manner.
• Partner within the broader BMS Risk Governance structure and 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 and to prioritize and mitigate threats to GDO objectives.

Key Responsibilities

• Execute a robust, integrated quality risk management (QRM) program addressing areas of business risk.
• Foster a global, cross-functional Quality Excellence and Inspection Readiness mindset at all times.
• Promote a high-Quality Culture framework by embedding risk management principles and demonstrating business benefits to partners and peers.
• Monitor GDO performance by assessing compliance and quality trends using QMS and related datasets.
• Act as a data specialist with fluency in clinical data analytics, interpretation and trend discovery to support evidence-based decision-making.
• Apply advanced risk management principles to proactively identify, assess, and mitigate risks across clinical operations.
• Assign priority and escalate risks as appropriate.
• Maintain functional Risk Oversight and monitor mitigation actions with effectiveness checks.
• Develop and execute business risk management strategies to support or supplement inspection readiness efforts, including the global auditing program and related activities (proactive Compliance Assessments, Quality Control, Issue Management, etc.).
• Drive end-to-end Risk Management by ensuring connection and escalation of emerging signals and potential risks by scope (process, program, region, study, supplier, investigator/site, etc.).
• Lead or participate in Continuous Improvement projects to identify and enable process improvements.
• Support the strategic direction of Risk Based Management within the business, including RBM innovation, education, and embedding.
• Provide coaching and mentorship to onboarders or new team members.
• Take on additional responsibilities as directed by leadership.

Knowledge, Skills & Experience

• 8+ 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 in a global matrix organization.
• Ability to lead and manage teams, provide direction, support, and motivation to achieve goals.
• Experience in matrix management and training, with leadership capabilities to inspire cross-functional teams.
• Excellent communication skills with the ability to engage and influence internal and external stakeholders, including Health Authorities.
• Strong presentation and negotiation skills; ability to resolve conflicts constructively within cross-functional teams.
• Ability to manage multiple projects with attention to detail, planning, time management and organizational skills.
• Experience driving issue escalation and conflict resolution.
• Strategic mindset to translate business process needs into effective development and implementation.
• Entrepreneurial mindset with speed, accountability and integrity, fostering a positive work environment.
• Proficiency in data and statistical analyses and interpretation, with data visualization to communicate risks and insights to varied audiences.
• Awareness of industry trends and dynamics in clinical trial processes and data collection.
• Demonstrated expertise in Risk Management within a regulated environment with emphasis on GCP, Quality and Operations.
• Keeps abreast of new regulations and standards and can adapt and promote necessary changes.

Qualifications

• Bachelor’s degree (or equivalent) is required; a degree in life sciences is preferred.
• Advanced degrees are a plus.

Additional Requirements

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

Note: If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With the vision Transforming patients’ lives through science, every employee contributes to work that goes beyond ordinary. We value global participation in clinical trials and uphold our shared values of passion, innovation, urgency, accountability, inclusion and integrity.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct work. Roles may be site-essential, site-by-design, field-based or remote-by-design. The occupancy type is determined by role responsibilities. Site-essential roles require 100% onsite shifts; site-by-design roles may be hybrid with at least 50% onsite; field-based and remote-by-design roles require travel as an essential function.

BMS is dedicated to accessibility. Applicants can request reasonable accommodations prior to accepting a job offer or during recruitment. For inquiries, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to view our Equal Employment Opportunity statement.

BMS supports employee well-being and recommends vaccination for Covid-19 and staying up to date with boosters where applicable.

BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws.

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

Bristol Myers Squibb is Disability Confident – Employer (UK Government scheme).