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The Position

We are seeking a highly motivated Director, Clinical Compliance and Oversight to join our dynamic team who will be responsible for clinical program compliance and oversight across the different stages of Verve’s cardiovascular development programs. The successful candidate will be skilled at both understanding and applying global compliance regulations, best training practices, and governance and oversight processes to clinical trials as they advance through clinical development. This position requires a collaborative partnership with cross functional team members across the organization, vendors, and clinical trial sites. The candidate will work to ensure the needs of the teams are addressed with a collaborative outlook and be solution oriented to ensure standards, processes, and training are fit for purpose.

Job Responsibilities

• Ensure clinical trials comply with global regulations, ICH/GCP, and internal processes by collaborating across Clinical Development.
• Review study documents, workflows, and outputs; provide guidance on remediation, training, and continuous process improvement.
• Monitor regulatory developments and evolving best practices; address compliance questions and advise on risk mitigation strategies.
• Identify and remediate quality issues through root cause analysis, CAPA development and management, and effectiveness checks.
• Track and report key risk and quality indicators (KRIs/KQIs) across Clinical Development.
• Maintain a robust compliance training program and support inspection readiness and audit activities in partnership with Quality.
• Develop and execute vendor management strategies aligned with company goals to drive quality, innovation, and operational efficiency.
• Oversee vendor outsourcing processes including RFPs, bid reviews, selection, contracting, budgeting, and performance monitoring.
• Implement governance frameworks (KPIs, scorecards, escalation procedures) to ensure consistent vendor oversight across the portfolio.
• Partner with Legal on contract negotiations, change orders, and PO lifecycle management.
• Develop site oversight strategies and ensure inspection readiness across clinical programs.
• Lead TMF oversight in an outsourced/hybrid model to ensure compliance with regulatory requirements and internal SOPs.
• Support regulatory inspection activities from preparation through post-inspection follow-up.
• Own budget planning and financial oversight, leveraging data to optimize resources and ensure fiscal responsibility.
• Drive strategic decision-making through data insights, cross-functional collaboration, and solution-oriented thinking.
• Lead change initiatives, ensuring smooth transitions while fostering sustainable growth and innovation.
• Build and mentor high-performing teams by promoting a collaborative, inclusive culture grounded in company values.
• Support professional development, set clear expectations, deliver feedback, and develop future leaders.
• Other duties as assigned.

Qualifications

• Education & Experience
  • Bachelor’s degree in a life science or allied health field (e.g. nursing, medical or laboratory technology).
  • At least 10 years of experience in clinical research with direct clinical compliance oversight and leading market inspection experience (eg. FDA, EMA, MHRA, or PMDA).

• Skills & Abilities
  • Ability to identify areas for process improvement and lead discussions to implement change
  • Excellent written and oral communication skills
  • Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
  • Good organizational skills for the management of clinical development compliance and working in a fast-paced environment
  • Strong understanding of best practices as it pertains to vendor governance, site oversight, team training, and trial master file setup and maintenance
  • Proficiency with word processing, spreadsheet, database, presentation software (i.e. MS Office skills such as Outlook, Word, Excel, and PowerPoint)
  • Proven ability to lead and develop teams, managing complex projects and solving abstract problems.
  • Demonstrated ability to drive contract execution with aggressive timelines
  • Strong communication and negotiation skills, with experience influencing stakeholders and aligning organizational objectives.
  • Demonstrated ability to set strategic direction and translate it into actionable plans.
  • High emotional intelligence, with skills in conflict resolution and understanding diverse perspectives.
  • Experience in budget management and accountability for departmental or cross-functional finances.
  • Ability to bring structure to ambiguous situations and develop overarching frameworks for projects.