Senior director non clinical development Vacatures

Over de vacature

Overview

As Senior Director Non-Clinical Development, you shape and execute the non-clinical strategy across Pharming's biopharmaceutical products, aligning with clinical and CMC plans. You lead a small scientific team, drive study quality, and ensure compliant processes and regulatory defendability. You'll influence portfolio decisions, collaborate with clinical teams, and manage resources and budgets. This role offers a chance to advance rare-disease therapies with strategic impact and cross-functional influence.

Arbeidsvoorwaarden / Benefits

• Competitive annual salary
• 8.33% holiday allowance
• Minimum of 30 vacation days
• Excellent pension plan

Verantwoordelijkheden

• Define and implement the non-clinical strategy aligned with clinical/CMC plans
• Provide leadership and development for a scientific team and ensure training
• Track performance metrics, drive continuous improvement, and deploy strategic changes
• Ensure high-quality non-clinical studies under applicable guidelines and defend the program to authorities
• Maintain regulatory-compliant processes, infrastructure, and risk management
• Collaborate with clinical teams to input on development activities
• Approve critical non-clinical documents (regulatory study docs, publications)
• Maintain current scientific landscape knowledge and lead budgeting/resource planning
• Provide non-clinical input to business activities (in-licensing, partnerships)
• Act as influential member of the R&D Leadership team and foster innovation

Belangrijkste vereisten

• PhD in Pharmacology or Toxicology or related field

• At least 15 years in pharmaceutical drug development with minimum 10 years in study program management

• At least 4 years of managerial experience

• Experience in pharmacokinetics and pharmacodynamics

• Experience with GLP and quality management systems

• Extensive experience in a highly regulated (ICH/GLP) environment

• Extensive experience writing pharmaceutical dossier documents

• Experience with EMA/FDA regulatory interactions

• Ability to work in a matrixed organization

• Excellent project/program management skills

• Ability to travel 10%

• Commitment to Pharming's mission and values

• strong leadership and people development

• cross-functional collaboration

• strategic thinking and decision-making

• GLP and regulatory quality systems

• Pharmacokinetics and Pharmacodynamics

• Regulatory dossier writing and submissions