Director, Head of Clinical Delivery and Monitoring Unit II

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

12d•Onsite

About The Position

As Director, Head of Clinical Delivery and Monitoring Unit II, you will oversee the assigned Delivery and Monitoring Strategy teams to ensure high-quality, risk-based, and efficient delivery of the entire clinical portfolio (Phase I–IV, RWE, ISS, and other studies). In this role, you will provide strategic and operational oversight for clinical delivery, patient centricity and monitoring, governance representation, cross-functional and CRO collaboration (as applicable), and continuous improvement of systems, processes, and performance across the department. Additionally, you will manage a diverse team, ensuring high-quality execution of clinical studies while driving the delivery and quality of Phase I-IV studies, epidemiology, real-world evidence studies, and early access programs within the clinical portfolio. You will oversee a team of Trial Clinical Delivery Leads (TCDLs), Program Clinical Delivery Leads (PCDLs), and Regional Clinical Delivery Leads (RCDLs) to ensure high-quality execution of clinical studies. You will engage with internal partners across GDO, Global Medical Affairs, and CROs to ensure seamless trial execution and performance accountability. You will represent the Clinical Delivery team at internal governance boards, ensuring operational feasibility and delivery considerations are evaluated.

Requirements

Bachelor’s degree in science, medical, life science or other clinical research-related discipline or equivalent and 8+ years in clinical research and operations, focusing on managing complex studies and teams.
OR
Master’s degree in science, medical, life science or other clinical research-related discipline or equivalent and 5+ years in clinical research and operations, focusing on managing complex studies and teams
5+ years of experience in people and resource management.

Nice To Haves

You possess a strong ability to interpret and anticipate business challenges, driving process improvements and innovative solutions.
You have demonstrated the ability to sponsor and drive transformation initiatives within clinical operations.
You exhibit outstanding leadership capabilities to direct, influence, and motivate diverse teams across functions and geographies.
You have strong analytical skills, enabling you to assess risks, solve problems, and make informed decisions.
You possess a high degree of cultural awareness and are adept at working in a multicultural environment with global teams.
You are skilled in implementing operational excellence strategies by leveraging expertise from Global Development Operations (GDO) and collaborating with partner functions.

Responsibilities

Clinical Delivery Oversight: You will lead and support Delivery and Monitoring teams to manage the full clinical portfolio lifecycle, ensuring high-quality, compliant, and timely execution of Phase I–IV, RWE, ISS, and other studies.
Operational Excellence: You will drive operational excellence by optimizing workflows, standardizing processes, and leveraging innovative tools to ensure efficient, scalable, and on-schedule clinical operations.
Risk Management: You will develop and implement proactive risk management strategies and risk-based monitoring to identify, mitigate, and resolve operational, compliance, and clinical risks across studies.
Collaboration and Networking: You will foster strong partnerships with internal and external stakeholders, representing Clinical Delivery in governance forums to ensure alignment, transparency, and seamless clinical trial execution.
Performance Improvement: You will continuously monitor performance metrics and drive process improvements, team development, and innovation to enhance clinical study quality and operational effectiveness.