[Hiring] Senior Director, Head of US Site Management @Bayer

Role Description

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

• 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 institutions, research networks, patient associations, and other external partners.
• Lead, coach, and develop a high-performing, inclusive US Site Management organization, including line managers and internal or external site management roles such as CRAs, CLMs, COSs, and related operational staff.
• Travel for this role is as required. Travel could be up to 50% domestic and international.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or a related field required.
• Experienced clinical operations leader with demonstrated ability to lead US site management, monitoring, study start-up, enrollment optimization, and strategic site partnership activities across complex development portfolios and matrixed organizations.
• Deep expertise in US study start-up, site management, monitoring, feasibility, enrollment optimization, and clinical trial execution.
• Strong knowledge of clinical operations, drug development processes, ICH-GCP, applicable legal and regulatory requirements, compliance expectations, inspection readiness, and local country requirements.
• Experience developing operating models, vendor strategies, oversight frameworks, metrics, dashboards, and risk-management approaches.
• Experience supporting regulatory authority inspections, sponsor audits, site audits, audit responses, and remediation activities.
• Strategic thinking with the ability to translate portfolio and enterprise priorities into US site-facing operational strategies.
• Strong analytical and problem-solving skills, including the ability to identify risk, evaluate options, interpret performance data, and implement practical solutions.
• Visible, motivational, and collaborative leadership style with the ability to lead through change, complexity, ambiguity, and transformation.
• Strong people leadership skills, including talent assessment, coaching, development, succession planning, and building resilient, inclusive teams.
• Ability to drive accountability, empower decision-making, and foster disciplined, customer-focused, quality-driven ways of working.
• Excellent communication, influencing, negotiation, and stakeholder-management skills across internal and external audiences.
• Demonstrated ability to work effectively across functions, organizational levels, geographies, and strategic partnerships.
• Innovation mindset with ability to assess and implement AI, automation, digital tools, and process improvements that enhance clinical trial execution.
• Commitment to high standards of quality, compliance, inspection readiness, operational performance, and continuous improvement.

Requirements

• Advanced degree such as PhD, MBA, or master’s degree preferred.
• Minimum of 12 years of experience in site management, clinical operations, clinical development, or related pharmaceutical, biotechnology, or healthcare leadership roles; or advanced degree with 10+ years of relevant experience.

Benefits

• Employees can expect to be paid a salary between $224,240.00 - $336,360.00.
• Additional compensation may include a bonus or commission (if relevant).
• Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.