Associate Director, Clinical Trial Risk Lead

Associate Director, Clinical Trial Risk Lead

BMS - Bristol-Myers Squibb

Warsaw, Poland

As an Associate Director, Clinical Trial Risk Lead (AD CTRL), you'll work with a significant portion of BMS's clinical trial portfolio, deploying Quality by Design and Risk Based Management principles to effectively prevent, mitigate and monitor risks to ensure the success of our clinical trials.

You'll be a recognised expert and a key contributor to the strategic direction of Risk-Based Management across the company; including representing BMS externally with industry groups and key partners. For the right person, this role offers both depth and breadth: deep technical challenge, real leadership responsibility, and the visibility that comes with influencing senior leadership and cross-functional teams.

What You'll Be Doing

Driving proactive risk management across a major clinical portfolio

• You'll own the end-to-end risk management process for your assigned studies from Quality by Design and protocol de-risking right through to lifecycle management and reporting;
• Using statistical methodologies and data visualisation tools, you'll leverage trends, outliers, and risk signals across clinical and operational data, and translate those findings into a clear, compelling risk narrative for study teams, key stakeholders and governance committees.

Being the connective tissue between data and decision-making

• You won't just produce reports, you'll shape how the organisation understands and responds to risk;
• You'll connect study-level Risk Review Meeting outcomes to portfolio-level insights, ensuring the right people have the right information to act quickly and confidently.

Leading and influencing across the organisation

• Whether it's escalating quality threshold deviations to the Quality Council, overseeing output from external partners and technology providers, or leading continuous improvement initiatives within TRIM, you'll be a trusted voice across Trial Delivery Support, Global Development Operations, and broader BMS functions;
• You'll also coach and mentor newer team members, helping build a culture of accountability, integrity, and inclusion.

What You Bring

• A degree in Life Sciences, Data Science, Statistics, Analytics, Business, or a related field;
• 8+ years in the pharmaceutical industry, with a strong grounding in drug development;
• 5+ years in clinical trial operations and/or Good Clinical Practice;
• Solid expertise in Risk-Based Monitoring principles; including Quality by Design, Risk Assessment & Control, and tools such as risk management plans and risk analytics platforms.

You're someone who can read complex data and tell a clear story from it. You're comfortable in front of senior leadership, equally at ease working cross-functionally, and you bring the kind of strategic thinking that helps an organisation stay ahead of challenges rather than react to them.