Global Head of Medical Operations

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

6h•$251,000 - $409,300

About The Position

This role is the architect of precision within Medical Affairs, ensuring the right people, processes, and data come together at the right moment. As Global Head of Medical Operations, you will set the strategic direction and operating model for a global function spanning Managed Access Programs, Medical Study Operations, and Project Management, leading a team of approximately 20 professionals across regions. You will serve as the integrator of the Medical Affairs organization, bridging product and functional planning, enabling cross-functional collaboration, and ensuring that operational infrastructure keeps pace with an evolving portfolio. In this role, you will own the full governance and performance of Medical Operations across the product lifecycle: designing centralized, decentralized, or federated support models that balance global consistency with regional needs; driving continuous improvement of procedures, workflows, and governance frameworks; and translating operational data into clear insights and recommendations for senior leadership. You will oversee compliant, timely execution of expanded access and compassionate use programs, and ensure that Medical Affairs sponsored evidence generation, including interventional, non-interventional, and investigator-initiated studies, meets the highest standards of quality, regulatory compliance, and scientific integrity. As a member of the Global Medical Affairs leadership team, you will partner with Clinical Development, Regulatory Affairs, Quality, Compliance, Finance, Procurement, and Information Technology, while retaining Medical Affairs ownership of operational standards and championing the responsible adoption of technology and automation across the function.

Requirements

Bachelor's degree in life sciences, healthcare, business, operations, project management, or a related field.
12+ years of experience in Medical Affairs, pharmaceutical, biotechnology, or clinical research operations within a regulated environment.
Direct experience in Medical Affairs study operations, managed access programs, or Medical Excellence functions.
5+ years of experience leading teams, including matrix and global leadership across regions and functions.
Deep working knowledge of Good Clinical Practice (GCP) and ICH E6.
Deep working knowledge of the operational requirements of Medical Affairs evidence generation, including interventional studies, non-interventional studies, investigator-initiated studies, expanded access, and external collaborative research.
Proven experience in operating model design, process improvement, budget management, vendor and contract research organization management, and performance measurement.
Advanced proficiency with operational systems, dashboards, and reporting tools.
Working knowledge of artificial intelligence and analytics applications and their compliance implications.
External applicants must be eligible to work in the US.

Nice To Haves

Advanced degree such as an MBA, MS, or PharmD.
Project management certification such as PMP or PRINCE2, or equivalent.
Experience in Oncology, Fertility, Immunology, or Neurology therapeutic areas.
Familiarity with grants, sponsorships, and investigator initiated study governance systems.
Experience with regulated operational platforms and business intelligence solutions.

Responsibilities

Set the strategic direction and operating model for a global function spanning Managed Access Programs, Medical Study Operations, and Project Management.
Lead a team of approximately 20 professionals across regions.
Serve as the integrator of the Medical Affairs organization, bridging product and functional planning.
Enable cross-functional collaboration.
Ensure that operational infrastructure keeps pace with an evolving portfolio.
Own the full governance and performance of Medical Operations across the product lifecycle.
Design centralized, decentralized, or federated support models that balance global consistency with regional needs.
Drive continuous improvement of procedures, workflows, and governance frameworks.
Translate operational data into clear insights and recommendations for senior leadership.
Oversee compliant, timely execution of expanded access and compassionate use programs.
Ensure that Medical Affairs sponsored evidence generation meets the highest standards of quality, regulatory compliance, and scientific integrity.
Partner with Clinical Development, Regulatory Affairs, Quality, Compliance, Finance, Procurement, and Information Technology.
Retain Medical Affairs ownership of operational standards.
Champion the responsible adoption of technology and automation across the function.