Director Clinical Operations

Position Overview

We are seeking an experienced clinical operations leader to oversee the execution of clinical development programs and strengthen collaboration with clinical research sites. This individual will be responsible for driving study performance, managing external service providers, supporting patient recruitment, and ensuring operational objectives are achieved across multiple clinical trials.

Working within a lean, externally supported clinical development environment, the Director will provide hands-on operational leadership, maintain accountability for third-party performance, and proactively address challenges that affect study timelines, site engagement, and enrollment.

The ideal candidate combines strong clinical trial management expertise with practical research site experience, sound scientific judgment, and the ability to translate operational challenges into actionable solutions. This role requires regular interaction with investigators and site personnel, including in-person visits to research centers.

Key Responsibilities

Clinical Program Management

• Lead operational planning and execution across assigned clinical studies, including timelines, budgets, resource allocation, and milestone tracking.
• Align study activities with broader clinical development goals and identify potential risks to successful execution.
• Coordinate cross-functional stakeholders to maintain progress and resolve operational challenges.

External Partner Oversight

• Manage CROs and other clinical service providers, including performance monitoring, deliverable review, budget oversight, and contract-related activities.
• Evaluate vendor effectiveness, identify performance gaps, and implement corrective actions as needed.
• Provide clear direction and accountability to external partners while identifying opportunities to improve efficiency and study outcomes.

Research Site Relationships and Engagement

• Establish productive relationships with principal investigators, study coordinators, and research site teams.
• Conduct on-site visits independently and in collaboration with external partners to assess site operations, identify challenges, and support study execution.
• Evaluate site capabilities, patient access, staffing constraints, and operational workflows to identify opportunities for improvement.
• Serve as a key point of contact for addressing site-level concerns and facilitating timely resolution.

Patient Recruitment and Enrollment

• Develop and implement targeted enrollment strategies in collaboration with research sites and external partners.
• Analyze recruitment trends, screening outcomes, enrollment progress, and site performance to identify barriers and prioritize interventions.
• Work with site teams to implement practical solutions that improve patient identification, screening, and participation.
• Monitor the effectiveness of recruitment initiatives and adjust strategies based on observed results.

Study Start-Up and Change Management

• Oversee operational readiness and site activation activities to support timely study initiation.
• Coordinate implementation of protocol amendments and other study changes, including impacts on budgets, contracts, training, patient visits, and timelines.
• Assess operational implications and provide recommendations to support informed decision-making.

Issue Management and Operational Accountability

• Establish clear processes for tracking study risks, site concerns, vendor deliverables, and outstanding decisions.
• Drive resolution of persistent operational issues through appropriate escalation, stakeholder alignment, and follow-through.
• Maintain visibility into study progress and ensure action items have clear ownership and defined next steps.

Site Training and Scientific Communication

• Facilitate investigator discussions, site education initiatives, and training sessions to support protocol understanding and consistent study execution.
• Communicate clinical and operational requirements effectively to physicians, coordinators, and other research professionals.
• Incorporate feedback from site personnel into recommendations for improving study processes and participant engagement.

Quality and Regulatory Compliance

• Promote adherence to Good Clinical Practice (GCP), approved protocols, and applicable clinical research requirements.
• Partner with quality, regulatory, and external study teams to address compliance concerns, audit findings, and documentation gaps.
• Support the maintenance of accurate, complete, and inspection-ready clinical trial records.

Operational Strategy and Portfolio Development

• Contribute to study feasibility assessments, site and country selection, vendor strategy, and resource planning for future clinical programs.
• Develop scalable operational processes to support portfolio growth and increasing study complexity.
• Identify future staffing, infrastructure, and external support requirements as clinical development activities expand.

Qualifications

• Bachelor's degree in life sciences, nursing, healthcare, or a related discipline required; advanced degree preferred.
• At least 10 years of clinical research experience, including leadership responsibility for clinical trial execution, timelines, budgets, and external partner oversight.
• Demonstrated experience managing CRO relationships and clinical vendors within a pharmaceutical, biotechnology, or clinical research organization.
• Strong understanding of sponsor responsibilities, clinical trial governance, and effective oversight of outsourced study activities.
• Significant experience working directly with clinical research sites, investigators, and study coordinators. Previous clinical research associate (CRA) experience is highly desirable.
• Proven ability to identify recruitment and enrollment challenges, develop practical interventions, and improve site performance.
• Strong understanding of clinical research operations, including site workflows, patient referral processes, staffing considerations, and participant visit requirements.
• Experience supporting site activation, protocol amendments, budget negotiations, and clinical trial contract management.
• Working knowledge of GCP requirements and clinical trial systems, including clinical trial management systems (CTMS), electronic trial master files (eTMF), and electronic data capture (EDC).
• Ability to interpret clinical and scientific information, engage confidently with medical professionals, and translate site feedback into operational recommendations.
• Demonstrated initiative, independent problem-solving, and sound decision-making in a fast-paced, resource-conscious environment.
• Experience supporting international clinical trials or preparing programs for expansion into additional countries is an advantage.
• Experience in therapeutic areas such as metabolic disorders, oncology, obesity, or related chronic diseases is preferred.
• Willingness and ability to travel regularly for research site visits, investigator meetings, and external partner engagements.

Leadership Profile

The successful candidate will be a proactive, detail-oriented clinical operations professional who combines strategic oversight with hands-on execution. They will be comfortable working in a small, evolving organization, influencing external partners, building trusted relationships with research sites, and taking ownership of issues through resolution.

Success in this role requires a balance of operational discipline, scientific credibility, collaborative leadership, and a practical understanding of the factors that drive clinical trial performance.