Group Lead Clinical Operations

headcount AG; Zürich; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

headcount AG in Switzerland seeks a Group Lead Clinical Operations to guide a growing team of Clinical Project Managers and shape the clinical development strategy. You will oversee global Phase I/II trials, ensure on-time delivery within budget, and manage CROs, sites and vendors in a fast-paced biotech environment.

Ideal candidates have extensive CRO management, regulatory submission experience and fluently communicate in English.

Qualifikationen

• Master’s degree or PhD in Life Sciences or a related discipline.
• 8–12+ years of Clinical Operations experience within biotechnology or pharmaceuticals.
• Extensive experience managing global Phase I and/or II clinical trials.
• Previous experience leading Clinical Project Managers or cross-functional clinical teams.
• Strong understanding of clinical development strategy.
• Proven experience managing CROs and external vendors.
• Experience preparing regulatory and ethics submissions.
• Excellent knowledge of ICH‑GCP and international clinical regulations
• Strong leadership, coaching and communication skills
• Ability to work successfully in a fast‑paced, entrepreneurial biotech environment
• Fluent English

Aufgaben

• Lead, mentor and develop a growing team of Clinical Project Managers.
• Provide scientific and operational guidance throughout clinical development programs.
• Allocate resources across projects and support workload planning.
• Foster collaboration across Clinical Operations and cross-functional departments.
• Drive continuous improvement of clinical processes, SOPs and operational excellence.
• Support recruitment, onboarding and development of new team members.
• Contribute to departmental strategy and organizational growth.
• Lead global Phase I and Phase II trials from planning to close-out.
• Ensure studies are delivered on time and within budget.
• Develop and review protocols, clinical study plans, ICFs and study reports.
• Oversee CROs, sites, labs and external vendors.
• Manage regulatory and ethics submissions.
• Identify study risks and implement mitigation strategies.
• Monitor study progress, data quality and vendor performance.
• Present study updates to senior management and stakeholders.
• Ensure compliance with ICH-GCP and regulations.

Kenntnisse

Leadership

People management

Coaching

Communication

Resource planning

Vendor management

Regulatory submissions

ICH-GCP

English (Fluent)

Ausbildung

Master’s degree or PhD in Life Sciences or related

Jobbeschreibung

Location: Greater Zurich Area | Switzerland

Your Responsibilities As Group Lead Clinical Operations

Leadership

• Lead, mentor and develop a growing team of Clinical Project Managers
• Provide scientific and operational guidance throughout clinical development programs
• Allocate resources across projects and support workload planning
• Foster collaboration across Clinical Operations and cross-functional departments
• Drive continuous improvement of clinical processes, SOPs and operational excellence
• Support recruitment, onboarding and development of new team members
• Contribute to departmental strategy and organizational growth

Clinical Operations

• Lead global Phase I and Phase II clinical studies from planning through execution and close-out
• Ensure studies are delivered on time, within budget and according to quality standards
• Develop and review key study documents, including protocols, clinical study plans, informed consent forms and study reports
• Oversee CROs, clinical sites, central laboratories and external vendors
• Manage regulatory and ethics submissions
• Identify study risks and implement mitigation strategies
• Monitor study progress, data quality and vendor performance
• Present study updates to senior management and external stakeholders
• Ensure compliance with ICH‑GCP (E6(R3)), applicable regulations and internal SOPs

Your Profile

• Master’s degree or PhD in Life Sciences or a related discipline
• 8–12+ years of Clinical Operations experience within biotechnology or pharmaceuticals
• Extensive experience managing global Phase I and/or II clinical trials
• Previous experience leading Clinical Project Managers or cross‑functional clinical teams
• Strong understanding of clinical development strategy
• Proven experience managing CROs and external vendors
• Experience preparing regulatory and ethics submissions
• Excellent knowledge of ICH‑GCP and international clinical regulations
• Strong leadership, coaching and communication skills
• Ability to work successfully in a fast‑paced, entrepreneurial biotech environment
• Fluent English

What You Can Expect

• Leadership responsibility within a rapidly growing Clinical Operations organization
• The opportunity to shape both clinical programs and team development
• High level of ownership and visibility across the organization
• International, collaborative and science‑driven culture
• Flat hierarchies and short decision‑making processes
• Modern offices in the Zurich area with excellent public transport connections

Due to Swiss employment regulations, only candidates who are currently eligible to work in Switzerland can be considered for this position.