Senior Director Non Clinical Development

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.

• 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

• 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

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…