Serve as the clinical program leader for one or more global, cross‑functional core teams—translating product strategy into executable clinical program plans and ensuring alignment with broader technical, regulatory, and business objectives.
Define and drive the clinical program roadmap, including strategy, requirements, milestones, and interdependencies across multiple complex studies.
Lead global study teams through all phases of execution—from early design and feasibility through study close‑out—ensuring scientific rigor, operational excellence, and compliance with worldwide Good Clinical Practice (GCP), ISO 14155, and other regional regulatory requirements.
Interface at a senior level with Executive Management, R&D, Regulatory Affairs, Quality, Operations, Marketing, and external partners/CROs to ensure technical and operational integration across program components.
Operationalize global clinical strategies, including study design approaches, regulatory evidence pathways, and site/country selection strategies informed by regional regulatory landscapes.
Oversee and manage complex program budgets, financial forecasting, and global resource allocation, ensuring optimal use of internal/external resources.
Establish and monitor KPIs for clinical execution, proactively identifying risks to study startup, enrollment, data quality, regulatory compliance, and program timelines—and driving mitigation strategies across global teams.
Lead vendor strategy and governance, including CRO and specialized vendor selection, contract oversight, performance management, and escalation resolution for multi‑region programs.
Implement innovative operational models and tools to optimize efficiency, quality, and scalability of global clinical execution (e.g., digital trial capabilities, centralized monitoring approaches, risk‑based quality management).
Represent the clinical program externally, providing senior‑level engagement with investigators, global KOLs, regulatory bodies (as appropriate), and other external stakeholders to ensure alignment on scientific and regulatory expectations.
Ensure integration of clinical insights into product development, partnering closely with R&D and technical program management teams to translate clinical outcomes into product improvements and future evidence needs.

Requirements

Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 13+ years related experience or a Master’s degree and 8+ years equivalent industry experience of a PhD and 5+ years of experience.
Strong regulatory knowledge, including Good Clinical Practices (GCPs) and ISO 14155.
Experience with protocol, ICF, CRF development.
Experience with global clinical study planning and execution in the medical device industry.
Experience serving as a Clinical representative on a product development core team.
Exceptional organizational skills and ability to deal with competing priorities.
Strong reasoning and problem-solving ability.
Excellent communication (written and verbal) and presentation skills along with leadership qualities.
Strong interpersonal skills and ability to work effectively on cross-functional & global teams.
Proficient with MS Office Suite (Excel, Word and PowerPoint), MS Project, and Smartsheet (optional/nice to have).

Benefits

A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical program managementglobal clinical study planningprotocol developmentICF developmentCRF developmentregulatory compliancefinancial forecastingKPI monitoringrisk managementvendor management

Soft Skills

organizational skillsproblem-solvingcommunication skillspresentation skillsleadershipinterpersonal skillscross-functional collaborationstrategic thinkingadaptabilitytime management

Certifications

Bachelor's degreeMaster's degreePhDGood Clinical Practice (GCP)ISO 14155