Your RoleMedical Affairs delivers its greatest impact when the right people, processes, and data come together at the right moment, and this role is the architect of that precision. 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.
Who You AreBasic / Minimum Qualifications- 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, including 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, and 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, including working knowledge of artificial intelligence and analytics applications and their compliance implications.
Preferred Qualifications- 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.
Pay Range for this position: $ 251,000 - $ 409,300
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
