Director, Clinical Operations

Role Summary

The Director, Clinical Operations will lead end-to-end planning, execution, and delivery of global clinical trials across all phases of development. This role manages clinical trial teams and external vendors to ensure timely, high-quality, and compliant execution of clinical programs. The Director provides leadership in cross-functional collaboration, resourcing, budget oversight, and strategic trial planning aligned with corporate objectives. The role is both strategic and operational and requires hands-on leadership. Location: Hybrid, 3 days a week in Conshohocken office.

Responsibilities

• Clinical Trial Oversight
  • Lead end-to-end planning and operational execution of assigned clinical studies in accordance with GCP, regulatory requirements, and company SOPs
  • Oversee study timelines, budgets, enrollment progress, and key milestones, ensuring proactive risk mitigation and issue resolution
  • Serve as the primary point of contact for clinical trial managers, CROs, and key site networks
• Team Leadership and Cross-functional Collaboration
  • Manage and mentor Clinical Trial Managers, Clinical Research Associates (CRAs), and supporting operations staff
  • Foster a culture of accountability, excellence, and continuous improvement
  • Contribute to organizational growth by refining clinical processes, tools, and SOPs
  • Contribute to the development of meeting materials and content and participate in Departmental meetings
• Vendor and CRO Management
  • Select, negotiate with, and manage CROs, central labs, and other third-party vendors
  • Ensure high standards of vendor performance through KPIs, quality metrics, and governance structures
  • Support implementation of vendor oversight frameworks and risk-based monitoring strategies
• Budget & Resource Management
  • Develop and track clinical budgets and team resource allocations
  • Provide regular reports and forecasting to senior management and Executive Directors showcasing progress, risks and mitigation strategies
• Quality, Compliance & Inspection Readiness
  • Ensure that all clinical operations activities are conducted in accordance with ICH-GCP, regulatory guidelines and internal SOPs
  • Support inspection readiness and participate in audits or health authority inspections, always ensuring inspection readiness

Qualifications

• Experience phase 2 / 3 global studies
• Demonstrated ability to scale teams and processes
• Experience overseeing CROs and supporting vendor teams
• MASH / MASH parallel therapeutic expertise (preferred)
• Proficient in CTMS, EDC and eTMF systems (e.g. Veeva, Medidata, etc.)
• Strong knowledge of ICH-GCP and EU regulatory environment (e.g. EU CTR, local ethics processes)
• Demonstrated ability to lead CRA teams in a global environment
• Excellent written and verbal communication skills in English; proficiency in additional European languages is a plus
• Detail-oriented with strong organizational and project management skills
• 10+ years of clinical operations experience, including 5+ years in a leadership role managing complex global trials

Education

• Bachelor’s degree in Life Sciences or a related discipline (advanced degree preferred)

Skills

• Strong scientific and technical skills
• Ability to lead a high functioning team and delegate
• Strong interpersonal capabilities and ability to build and maintain networks
• Ability to influence both in-line communications and cross-functional teams
• Ability to anticipate and resolve problems effectively
• Strong verbal communication and technical writing skills
• Fluent in English language; proficiency in additional European languages is a plus
• Ability to present clearly using scientific and regulatory terminology
• Excellent organizational skills
• Comfort with ambiguity
• Display a sense of urgency; identify challenges and problems and take initiative to identify solutions