Head of Clinical Operations, Grants, and Regulatory Affairs

The Head of Clinical Operations provides strategic leadership and operational oversight for the planning, execution, and management of clinical studies, regulatory affairs, and grant submissions. This role ensures studies are conducted efficiently, ethically, and in compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards. The Head of Clinical Operations leads cross-functional teams, manages external partners such as CROs and vendors, and drives operational excellence across the clinical development portfolio.

Key Responsibilities

Clinical Strategy & Leadership

• Develop and implement the clinical operations strategy to support the company’s clinical development programs.

• Provide leadership across all phases of clinical studies, ensuring studies are delivered on time, within budget, and to the highest quality standards.

• Collaborate with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, and other functions to support clinical program goals.

• Contribute to clinical development plans and study design.

• Test subject recruitment, management, and consents

Operational Execution

• Oversee the planning, initiation, execution, monitoring, and close-out of clinical studies.

• Ensure adherence to regulatory requirements, ICH-GCP guidelines, and company SOPs.

• Manage timelines, budgets, resources, and risks across the clinical portfolio.

• Establish metrics and dashboards to track study performance and operational effectiveness.

Study Site and Vendor Management

• Select, oversee, and manage CROs, clinical sites, and other external vendors.

• Develop relationships with new clinical study sites (internal, academic, and CROs).

• Negotiate scopes of work, budgets, and timelines with external partners.

• Monitor vendor performance and ensure deliverables meet contractual and quality standards.

Team Leadership & Development

• Build, lead, and mentor a high-performing clinical operations team.

• Define organizational structure, roles, and responsibilities to support company growth.

• Foster a culture of accountability, collaboration, and continuous improvement.

Quality & Compliance

• Ensure clinical studies comply with applicable regulatory standards and ethical guidelines.

• Partner with Quality Assurance to support audits and inspections.

• Identify operational risks and implement mitigation strategies.

Process Improvement

• Develop and implement best practices, SOPs, and operational processes.

• Drive innovation in clinical trial operations, including adoption of digital tools, decentralized trials, and new operational models.

Regulatory & Medical Device Compliance Responsibilities

• Partner with Regulatory Affairs to ensure clinical studies support regulatory submissions for medical devices, including IDE (Investigational Device Exemption), 510(k), De Novo, and international regulatory approvals.

• Ensure clinical trials are designed and executed in accordance with applicable device regulations, for medical device clinical investigations.

• Provide operational leadership for clinical studies supporting regulatory submissions to agencies such as the U.S. Food and Drug Administration (FDA) and other global regulatory authorities.

• Contribute to regulatory strategy by ensuring clinical evidence generation aligns with regulatory expectations for device safety and effectiveness.

• Oversee preparation and operational input for regulatory documents including clinical investigation plans (CIPs), clinical study reports (CSRs), presubmissions, and post-market clinical follow-up plans.

• Ensure clinical trial documentation supports Design Controls and Risk Management processes.

• Support regulatory inspections and audits by regulatory authorities and notified bodies.

• Collaborate with Regulatory, Quality, and Clinical teams to ensure compliance with medical device reporting (MDR), vigilance reporting, and adverse event reporting requirements.

• Ensure clinical data collection and management meet regulatory standards required for device approval and commercialization.

• Contribute to post-market clinical evidence generation, including post-approval studies and real-world evidence programs.

Grant Management & Sponsored Research Responsibilities

• Lead operational management of externally funded research programs supported by grants from organizations such as the National Institutes of Health (NIH), National Science Foundation (NSF), foundations, and other government or nonprofit sponsors.

• Collaborate with finance, research administration, and principal investigators to ensure compliance with grant requirements, reporting obligations, and budgetary restrictions.

• Oversee grant-funded clinical studies to ensure alignment with sponsor objectives, approved protocols, and regulatory requirements.

• Manage grant budgets, ensuring proper allocation of funds, monitoring of expenditures, and adherence to sponsor guidelines.

• Coordinate preparation and submission of grant progress reports, annual reports, and final reports to funding agencies.

• Track study milestones, deliverables, and performance metrics tied to grant funding agreements.

• Ensure all research activities conducted under grants comply with applicable regulations, including requirements from the U.S. Department of Health and Human Services (HHS) and institutional research policies.

• Support development of new grant proposals.

• Coordinate cross-functional teams and external collaborators, including academic partners and research institutions, involved in grant-funded projects.

• Ensure proper documentation and recordkeeping for grant-funded clinical research to support audits, financial reviews, and regulatory inspections.

• Develop a robust grants program with a pipeline of new applications.

Qualifications

Education

• Bachelor’s degree

• Advanced degree (MS, PhD, MPH, PharmD, MD, or MBA) preferred

Experience

• 12+ years of clinical research experience, with at least 5 years in a leadership role

• Proven experience managing clinical studies

• Experience working with CROs and managing vendor relationships

• Track record of successfully delivering complex clinical and regulatory programs

• Experience with submission of 510k and de novo device applications to FDA

Skills & Competencies

• Deep knowledge of clinical trial processes, regulatory requirements, and ICH-GCP

• Strong leadership and team development capabilities

• Excellent project management and organizational skills

• Strategic thinking with strong operational execution

• Strong communication and stakeholder management skills

• Ability to work in a fast-paced, evolving environment

Preferred Experience

• Experience in medical devices

• Experience with global regulatory environments

• Experience scaling clinical operations in a growing organization

• Statistical experience

Key Performance Indicators (KPIs)

• Clinical study milestones achieved on schedule

• Budget adherence across clinical programs

• Quality and compliance metrics (audit outcomes, protocol deviations)

• Site activation and patient enrollment timelines

• Successful regulatory applications

• Successful grant applications

Contact

For more information or to apply, please contact hiring@esperto.health