Associate Director, Operational Excellence

This is a fully remote position, open to applicants in Germany.

📋 Description

• Spearhead strategic initiatives aimed at enhancing clinical trial processes and promoting operational efficiency within GCP-regulated activities.

• Create and uphold GCP-compliant process frameworks specifically designed for early-phase oncology trials.

• Partner with cross-functional teams (such as Clinical Operations, Clinical Development, QA, and Project Management) to pinpoint process weaknesses, bottlenecks, and implement enhancements.

• Perform gap analyses to uncover potential deficiencies in business processes and/or systems.

• Develop new Standard Operating Procedures (SOPs) and update existing documents to align with optimized, compliant, and scalable practices.

• Oversee SOP review cycles, integrating stakeholder feedback and ensuring compliance with internal policies and relevant regulatory requirements.

• Evaluate operational data and performance metrics to enable data-driven decision-making and foster accountability.

• Promote risk-based strategies in clinical operations, including proactive risk identification, mitigation planning, and oversight of Corrective and Preventive Actions (CAPA).

• Assist with inspection readiness efforts and collaborate closely with QA and operational teams, playing a key role in internal audits and regulatory inspections.

⛳️ Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related discipline.

• At least 10 years of experience in clinical research, with a minimum of 5 years in a role focused on operational excellence, quality, or process improvement.

• Extensive experience in drafting process documents and converting operational department requirements into practical, streamlined, and compliant process descriptions.

• Comprehensive knowledge of ICH-GCP and regulatory standards pertinent to oncology trials.

• Strong analytical abilities with a proven track record of translating data into actionable operational insights.

• Demonstrated success in leading cross-functional improvement initiatives within a fast-paced biotech or startup context.

• Exceptional communication and facilitation skills; capable of influencing without direct authority.

• Proficient in English, both spoken and written.

• Experience in a biotech environment, ideally within a startup.

• Familiarity with authority inspections (FDA, EMA, MHRA).

🏝️ Benefits

• Contribute to innovative therapies.

• Collaborate in an international and diverse team.

• Advance your career in a supportive, dynamic environment.

• Push boundaries with innovative science.