Strategic Leader, Non-Clinical Development

Pharming Group; Leiden; On-site; EUR 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary

8.33% holiday allowance

Minimum 30 vacation days

Excellent pension plan

Job summary

Pharming Group is seeking a Senior Director Non-Clinical Development to shape and execute the strategy for non-clinical programs across all products. You will lead a highly scientific team, ensure regulatory alignment, and safeguard quality throughout the development portfolio.

You will drive cross-functional collaboration with clinical, CMC, and external partners, oversee risk management, and defend the program in interactions with EMA/FDA.

Qualifications

• PhD required and relevant field.
• 15+ years of pharmaceutical drug development experience.
• 10+ years in study program management.
• 4+ years of managerial experience.
• Experience with GLP/ICH quality systems.
• Experience dealing with EMA/FDA in regulatory contexts.
• Ability to work in a matrixed organization.
• Excellent project/program management skills.

Responsibilities

• Define non-clinical strategy aligned with clinical/CMC plans.
• Lead a scientific non-clinical team (3 FTEs) and develop talent.
• Monitor performance metrics and drive continuous improvement.
• Ensure quality and regulatory compliance of non-clinical studies.
• Defend development programs to regulatory authorities.
• Oversee budget, resourcing and financial planning.
• Collaborate with clinical to inform development activities.
• Approve key non-clinical documents and publications.
• Stay updated on scientific landscape and developments.
• Provide non-clinical input to in-licensing and partnerships.
• Be an influential member of the R&D Leadership team.
• Foster innovation and creativity.

Skills

Strategic leadership

Program management

Regulatory understanding

Cross-functional collaboration

Communication

Education

PhD in Pharmacology or Toxicology or related field

Job description

Pharming Group is seeking a Senior Director Non-Clinical Development to shape and execute the strategy for non-clinical programs across all products. You will lead a highly scientific team, ensure regulatory alignment, and safeguard quality throughout the development portfolio.

You will drive cross-functional collaboration with clinical, CMC, and external partners, oversee risk management, and defend the program in interactions with EMA/FDA.