Senior Director, Head of US Site Management

Bayer•Whippany, NJ

9d•Remote

About The Position

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.

Requirements

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

Nice To Haves

Advanced degree such as PhD, MBA, or master’s degree
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.

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