Head of Clinical Operations
Location: Switzerland (hybrid or remote within Switzerland)Company Type: Small / Boutique CRO – Sponsor-Dedicated ModelTherapeutic 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
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