Head of Clinical Operations

Head of Clinical Operations

Location: Switzerland (hybrid or remote within Switzerland)
Company Type: Small / Boutique CRO – Sponsor-Dedicated Model
Therapeutic Area: Oncology (solid tumours & hematology)

My Client is looking for a Head of Clinical Operations to provide strategic and hands-on leadership for all clinical trial activities delivered to a dedicated oncology sponsor. A key mandate of this role is to build, structure, and scale the Clinical Operations function, supporting rapid growth while ensuring high-quality delivery of oncology clinical trials in compliance with ICH-GCP, Swissmedic, EMA, and FDA regulations.

This role is ideal for a leader who has previous experience building clinical operations teams, establishing processes, and scaling delivery in a small or growing CRO environment.

Key Responsibilities

Clinical Operations Leadership

• Lead all clinical operations activities across oncology studies (Phase I–III).

• Serve as the primary operational interface with the sponsor, ensuring alignment on strategy, timelines, and execution.

• Translate sponsor clinical development strategy into robust operational plans.

Clinical Operations Team Build & Scale

• Build, develop, and scale the Clinical Operations team (Clinical Project Managers, CRAs, Study Start-Up Specialists, CTAs) in line with company growth.

• Lead recruitment, onboarding, training, and mentoring of clinical operations staff.

• Define team structure, roles, performance objectives, and development pathways.

• Establish a high-performance culture focused on quality, accountability, and sponsor satisfaction.

• Leverage prior experience in building clinical teams to implement scalable and sustainable operating models.

Study Oversight & Delivery

• Oversee end-to-end delivery of oncology clinical trials from start-up through close-out.

• Ensure effective oversight of study start-up, regulatory submissions, site management, monitoring, and vendors.

• Proactively identify and mitigate risks specific to oncology trials (complex protocols, safety oversight, recruitment challenges).

Quality & Compliance

• Ensure compliance with ICH-GCP, Swissmedic, EU CTR 536/2014, and FDA requirements.

• Lead inspection readiness and support regulatory audits and inspections.

• Oversee CAPA implementation and continuous improvement initiatives.

Process Development & Governance

• Develop, implement, and optimise clinical operations SOPs, workflows, and KPIs suitable for a sponsor-dedicated CRO.

• Establish governance models to support current delivery and future expansion.

Budget & Vendor Management

• Oversee clinical trial budgets, forecasting, and resource planning.

• Manage CRO partners, vendors, and functional service providers.

Cross-Functional Collaboration

• Work closely with Medical Affairs, Regulatory Affairs, Safety, Data Management, Biostatistics, and Quality teams.

• Support business development by providing operational input into proposals and sponsor discussions.

Required Qualifications

• Degree in Life Sciences (BSc, MSc, PharmD, PhD, or equivalent).

• 10+ years of experience in clinical operations, including leadership roles.

• Strong experience in oncology clinical trials.

• Proven experience working within a CRO or sponsor-dedicated model.

• Demonstrated success in building and scaling clinical operations teams.

• In-depth knowledge of ICH-GCP, EMA, and FDA regulations.

Preferred Experience

• Prior role as Head/Director of Clinical Operations or Senior Clinical Operations Leader.

• Experience building teams in a small or high-growth organisation.

• Early-phase oncology trial experience (FIM, dose-escalation, adaptive designs).

• Experience working with Swiss and EU oncology sites.

• Familiarity with CTMS, eTMF, and vendor oversight frameworks.

Key Competencies

• Strategic yet hands-on leadership style

• Strong sponsor relationship management

• Proven ability to build and scale teams

• Operational excellence and risk management

• Clear, confident communication

• Entrepreneurial mindset suited to a small CRO