Head of Clinical Operations (MedTech)

Position Overview

We are seeking an experienced leader to take on the role of Head of Clinical Operations for a pioneering MedTech company in the Leipzig region. This role is initially contracted for two years with the possibility of extension to a permanent position.

Key Responsibilities

• Assume strategic responsibility for all clinical study programs within the company.
• Develop and execute a global strategy for Clinical Operations aligned to company goals.
• Plan, direct, and monitor clinical studies ensuring adherence to timelines, quality standards, and budgetary constraints.
• Ensure compliance with regulatory frameworks such as ICH-GCP and internal Standard Operating Procedures (SOPs).
• Lead, develop, and expand the Clinical Operations team to meet operational needs.
• Manage and oversee external partners including CROs, service providers, and investigation sites.
• Responsible for managing clinical trials throughout their full lifecycle from initiation to closure.
• Identify, assess, and resolve risks and challenges encountered during clinical studies.
• Collaborate closely with internal departments such as Medical, Regulatory, and Quality teams.
• Support audits, inspections, and communication with regulatory authorities.
• Contribute to study protocols, regulatory submissions, and strategic development plans.
• Report regularly to Senior Management and assist with board and investor presentations.

Candidate Requirements

• Degree in Life Sciences, Medicine, Pharmacy, Biomedicine, or a related discipline.
• A minimum of 5 years' experience in Clinical Operations, preferably within a MedTech environment focused on Class III medical devices.
• In-depth understanding of ICH-GCP guidelines, ISO 14155, and relevant regulatory requirements.
• Proven leadership experience managing teams and handling complex clinical trial programs.
• Demonstrated expertise in managing global studies and coordination with external service providers.
• Strong skills in strategic planning, organizational development, and problem-solving.
• Excellent communication and leadership abilities.
• Experience working in dynamic, fast-growing company environments.
• Fluency in English with strong negotiation capabilities.

Benefits and Working Conditions

• Key strategic position with substantial responsibility and direct impact on company objectives.
• Collaboration with top-level management.
• Engagement in an international, innovative workplace.
• Opportunity to shape and develop processes and teams.
• Work on clinically critical programs prioritizing quality and patient safety.
• Dynamic setting characterized by rapid decision-making.