Senior Director 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

The role

The Senior Director Non-Clinical Development determines and executes the strategy of Pharming's non-clinical development programs for Pharming's biopharmaceutical products and leads the non-clinical team. Responsibilities include non-clinical development of all of Pharming’s products including the modules for the regulatory filing and ensure consistency across the portfolio.

The Senior Director Non-Clinical Development determines and executes the strategy of Pharming's non-clinical development programs for Pharming's biopharmaceutical products and leads the non-clinical team. Responsibilities include non-clinical development of all of Pharming’s products including the modules for the regulatory filing and ensure consistency across the portfolio.

Areas of responsibility

• Determine the non-clinical strategy for Pharming’s products, ensure alignment with the clinical and CMC strategy and ensure proper implementation and execution
• Provide leadership to a highly scientific non-clinical team (3 FTEs); develop people to their full potential and ensure that people are properly trained to execute the job
• Track, analyze and monitor performance metrics; set goals, foster a culture of continuous improvement and implement (organizational) changes to achieve efficient deployment of strategy
• Ensure the right quality of all non-clinical studies according to the applicable guidelines and defend the non-clinical development program to the relevant authorities
• Ensure that processes, organization and infrastructure are in place to ensure compliance with regulatory guidelines
• Drive the non -clinical risk management process and prepare mitigating actions. Ensure consistency across the portfolio
• Collaborate with clinical function to provide input on development activities
• Approve critical non-clinical documents (e.g. regulatory study documents, scientific publications)
• Maintain current knowledge of the scientific landscape and developments
• Be responsible for sound financial planning/spending and resourcing of the non-clinical programs
• Provide non-clinical expertise as required to business activities such as in-licensing and third-party collaborations, based on scientific and managerial expertise
• Be an influential member of the R&D Leadership team
• Empower innovation and creativity
• Performs other duties as assigned

Qualifications & Experience

• PhD degree in Pharmacology or Toxicology or related field
• At least 15 years relevant experience in pharmaceutical drug development of which min. 10 years study program management experience
• At least 4 years managerial experience
• Experience in Pharmacokinetics and Pharmacodynamics
• Experience with GLP and other quality management systems
• Extensive experience working in a highly regulated (ICH and GLP) environment
• Extensive experience in writing pharmaceutical dossier documents
• Extensive experience with government agencies such as EMA and FDA to defend nonclinical record
• Ability to worked in a matrixed organization
• Excellent project/program management skills
• Ability to travel (estimated at 10%)
• Commitment and alignment to Pharming’s mission, core values and behaviors

Who We Are

We’re built on a simple belief: people living with rare diseases deserve more.

Pharming is a global biotechnology company taking on some of the toughest rare disease challenges. We develop and commercialize innovative therapies for rare and ultra-rare immunological and genetic diseases with significant unmet need, where our scientific and commercial expertise, long‑term commitment, and real partnership can help advance care.

We put patients at the heart of our work. Their insights, along with those of caregivers, clinicians, scientists, and partners, shape our strategy, guide our decisions, and help turn science into meaningful progress. We keep it simple, act with urgency, and get it done — expanding access to approved therapies, advancing high‑value pipeline programs, and building a leading global rare disease company.

Our vision is simple: a world where people living with rare diseases don’t wait for progress or care. Together with the communities who inspire us, we’re opening new possibilities — proving that breakthroughs aren’t just discovered. They’re created together.

Ready to make a difference? Join us.

What It’s Like To Work Here

At Pharming, every role helps move rare disease therapies closer to the people who need them. We make it happen together, across teams, disciplines, and borders, because breakthroughs don’t happen in silos. Rare diseases are complex, and meaningful progress takes people who ask better questions, challenge each other, and turn insight into action. Here, you won’t work on the sidelines. Pharming is a place for builders, problem‑solvers, and bold thinkers who move with urgency, take ownership, and stay focused on what matters most: improving the lives of people living with rare diseases. Advancing rare disease care isn’t the work of one team or one leader. It’s all of us, building what’s next together.

In addition, we offer:

• Competitive year salary
• 8.33% holiday allowance
• A minimum of 30 vacation days for a healthy work‑life balance
• Excellent pension plan to secure your future