Senior Director, Clinical Strategy and Delivery

Location: Spain

Company

hirify.global supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics through clinical research services.

What you will do

• Contribute to proposal development and bid defense activities on behalf of Clinical Operations, including risk-based monitoring strategies.
• Collaborate with start-up teams to keep study activities within expected timelines and escalate delays.
• Create and oversee monitoring strategies for internal teams and sponsors, providing rationale for the selected approach.
• Evaluate risk assessment and categorization processes for quality, consistency, and ICH compliance.
• Oversee management of protocol execution risks and ensure closed-loop issue resolution.
• Work with technology vendors to operationalize monitoring strategies and support central monitoring activities.

Requirements

• Bachelor’s degree in a related field, or an equivalent combination of education, training, and experience.
• At least 12 years of clinical research experience, including 5 or more years as a Clinical Trial Manager, Clinical Lead, or in project management.
• Expert knowledge of GCP, ICH E6 R2, and applicable regulatory requirements.
• Experience implementing risk-based monitoring methodologies and concepts.
• Strong understanding of clinical operations delivery from study start-up through maintenance and close-out.
• Expertise with central monitoring approaches, systems, and tools, plus strong project financial management experience.

Nice to have

• Line management experience.

Culture & Benefits

• Flexibility and balance to support individual work and life needs.
• Opportunities for professional growth, skills development, and career advancement.
• A collaborative environment where employee ideas and input influence ways of working.