Senior Director, Head of US Site Management

Senior Director, Head of US Site Management

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us.

If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

The Senior Director, Head of US Site Management, leads all US site-facing clinical trial activities across the development portfolio. This operational leadership role is responsible for US Site Management & Monitoring, Clinical Trial Optimization & Strategic Partnership functions, providing strategic leadership for study start-up, site management, and monitoring to drive predictable execution, accelerate timelines, improve enrollment performance, ensure high-quality data, and establish strategic site partnerships.

As a member of the Clinical Customer Engagement & Operations senior leadership team, this role also supports strategic initiatives across the development organization.

Your tasks and responsibilities include:

• Build, lead, and continuously strengthen US site management, monitoring, and study start-up capabilities across applicable clinical programs;
• Develop and execute US site strategies that optimize site selection, activation, enrollment, retention, monitoring, and overall study performance;
• Establish consistent, scalable monitoring models, including fit-for-purpose risk-based monitoring approaches aligned to study needs and regulatory expectations;
• Provide strategic and operational leadership for US site-facing activities, ensuring disciplined execution across study start-up, site management, monitoring, enrollment optimization, and strategic partnerships;
• Partner closely with Global Clinical Customer Engagement & Operations, Clinical Development, Data Management, Development Services, Quality, Regulatory, Medical Affairs, Pharmacovigilance, Market Access, Legal, Procurement, Finance, Human Resources, and other enabling functions to ensure seamless program and trial execution;
• Identify, assess, and mitigate site-level operational, quality, compliance, budget, timeline, and resourcing risks, driving timely escalation, corrective actions, and sustainable solutions;
• Establish scalable processes, operating models, metrics, KPIs, and dashboards to monitor performance, improve site delivery, enhance transparency, and support data-driven decision-making;
• Define and oversee vendor strategy, vendor oversight, risk management, performance expectations, and governance models for site management, monitoring, and study start-up activities;
• Provide expert operational insight into feasibility, country and site strategy, monitoring strategy, enrollment planning, budget planning, and resource allocation;
• Create, implement, and continuously improve standard operating procedures, work instructions, documentation standards, and inspection-readiness practices;
• Participate in regulatory authority inspections and sponsor audits and oversee site audit activities in partnership with Quality;
• Ensure compliance with ICH-GCP, applicable regulatory requirements, internal standards, local requirements, and inspection-readiness expectations;
• Assess opportunities to transform site management and monitoring capabilities through AI, automation, digital tools, process simplification, and innovation;
• Build and maintain strategic relationships with investigative sites, site networks, CROs, vendors, academic…