Jobid: 3195967726 (0.11)
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
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