Senior Director, Non-Clinical Development & Strategy

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

Benefits offered by this job

Holiday allowance 8.33%

Vacation days (min 30)

Pension plan

Job summary

Pharming Group is seeking a Senior Director Non-Clinical Development to define and drive the non-clinical strategy for its biopharmaceutical portfolio. You will lead a small, highly scientific team, ensuring GLP-compliant studies, regulatory defense, and seamless collaboration with clinical and CMC to align development programs.

The role demands extensive experience in regulated environments, strong leadership, and the ability to influence R&D strategy.

Qualifications

• 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 regulated environments (ICH/GLP).
• Experience with EMA and FDA interactions to defend nonclinical records.
• Ability to work in a matrixed organization.
• Strong project/program management skills.
• Ability to travel (~10%).

Responsibilities

• Define and execute the non-clinical strategy for Pharming’s products.
• Lead a 3 FTE non-clinical team and develop staff capabilities.
• Monitor performance metrics and drive continuous improvements.
• Ensure GLP-compliant non-clinical studies and defend programs to authorities.
• Ensure regulatory compliance across processes and infrastructure.
• Collaborate with clinical to align development activities.
• Approve critical non-clinical documents (regulatory studies, publications).
• Provide non-clinical input to business activities like in-licensing and collaborations.

Skills

Leadership

People management

Project management

Cross-functional collaboration

Regulatory knowledge

GLP experience

PK/PD

Travel willingness

Education

PhD in Pharmacology or Toxicology

Job description

Pharming Group is seeking a Senior Director Non-Clinical Development to define and drive the non-clinical strategy for its biopharmaceutical portfolio. You will lead a small, highly scientific team, ensuring GLP-compliant studies, regulatory defense, and seamless collaboration with clinical and CMC to align development programs.

The role demands extensive experience in regulated environments, strong leadership, and the ability to influence R&D strategy.