Head of Clinical Operations

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🔥 0 minutes ago

🇫🇷 France – Remote

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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Resilience

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

🏭 Manufacturing

🏥 Healthcare

📦 Logistics

Manufacturing • Healthcare • Logistics

Resilience is a leading biomanufacturing innovation company focused on the development of novel medicines. Specializing in the manufacturing of complex medicines such as cell and gene therapies, Resilience partners with small and mid-sized biotech firms to provide customized solutions that leverage cutting-edge technologies and scientific advancement. Their approach includes high-tech, end-to-end drug substance and drug product manufacturing capabilities aimed at ensuring rapid, safe, and scalable production. Resilience operates primarily in North America, with expertise in delivering regulatory-compliant solutions across global markets, enhancing the reliability and accessibility of biopharmaceutical supply chains.

📋 Description

• Lead all clinical operations for Resilience-sponsored RCTs, investigator-initiated studies, RWE projects and industry-partner studies • Report directly to the Chief Medical Officer • Manage a team of five to six Senior CTMs, CTMs and CRAs • Step in operationally on projects when backup is needed • Deliver studies on time, within budget and to expected quality standards while managing team workload • Provide medical leadership with visibility into study timelines, budgets and risk registers • Prepare clinical operations for a growing number of industry partners • Manage study budgets, timelines, risk registers, GCP compliance, milestones and performance indicators • Run weekly reviews and reporting for all projects • Allocate projects, assign tasks, organise backup, prioritise work and anticipate recruitment needs • Manage and develop team members through goal-setting, reviews and coaching • Maintain SOPs, templates and tools; prepare for audits and inspections • Act as escalation point for sites, investigators and partners regarding delays, budget overruns and quality issues • Build the operational model for the industry-partner clinical research offering, including costing, processes, tools and staffing • Collaborate cross-functionally with Commercial, Legal, Finance, Clinical Development, Biostatistics, Data Management, Regulatory, Compliance, Market Access and Product

🎯 Requirements

• Manage several studies in parallel, including budgets, timelines, resources and risks • Lead a clinical operations team, balance workloads and develop each team member’s autonomy • Estimate study costs, build budgets and monitor spending • Build and maintain a quality system, including SOPs, templates and audit preparation, compliant with GCP, ICH guidelines, the French Jardé law and GDPR • Manage relationships with sites, investigators and industry partners, including escalation situations • Professional-level English, written and spoken • Strong clinical research expertise, particularly in GCP, study budgets and timelines • Strong leadership and decision-making skills • Strategic vision and sound judgement in ambiguous situations • Clear, structured communication adaptable to leadership and operational teams • Excellent interpersonal skills and collaborative, cross-functional mindset • Degree in life sciences, pharmacy, clinical research or biomedical engineering—MSc, MD, PharmD or PhD • At least eight years of experience in clinical research, including three years managing a team or study portfolio • Experience leading studies for sponsors or industry partners in a CRO, pharmaceutical, biotech or medtech environment • Ideally, experience with real-world studies or medical devices • Knowledge of ISO 14155 is a plus

🏖️ Benefits

• Work fully remotely from France • Regular travel related to the role • Opportunity to lead clinical operations at a growing medtech company • Opportunity to shape the team’s organisation, processes and tools • Opportunity to help develop the clinical research offering for industry partners • Opportunity to contribute to studies combining clinical research, digital tools and patient-centred follow-up across several therapeutic areas

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