Associate Director, PKPD Programmer

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, PKPD Programmer in Netherlands.

The Associate Director, PKPD Programmer will lead a team of programming specialists to deliver high-quality pharmacokinetic and pharmacodynamic analyses that support drug development and regulatory submissions. This role combines technical expertise with leadership responsibilities, overseeing dataset construction, analysis programs, and quality assurance for PPK, PKPD, exposure-response, and NCA analyses. You will collaborate closely with project teams and clients, ensuring timely and accurate deliverables while mentoring junior staff. Operating in a fast-paced, scientifically rigorous environment, you will contribute to process improvements and innovative programming solutions that enhance efficiency and support decision-making across multiple therapeutic areas. This position provides the opportunity to impact drug development outcomes and regulatory success on a global scale.

• Lead and manage a team of PKPD programmers, providing guidance, training, and mentorship to enhance technical skills and efficiency.
• Oversee the preparation and management of datasets for PPK, PKPD, exposure-response (efficacy and safety), C-QTc, and NCA analyses, ensuring compliance with CDISC ADaM/SDTM standards.
• Develop, maintain, and optimize high-quality R and SAS programs to facilitate dataset construction and analyses.
• Conduct exploratory analyses to support modeling and reporting, ensuring accuracy and scientific rigor.
• Interface directly with clients on dataset specifications, data transfers, and queries, delivering clear and actionable insights.
• Ensure the completion of electronic submission packages and adherence to regulatory requirements for drug submissions.
• Drive process improvements in programming methodology, automation, and quality assurance to enhance team efficiency and deliverables.

Requirements

• BS, MSc, PhD, PharmD, or equivalent in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields.
• Minimum 10 years of experience in PKPD programming, analysis, reporting, and regulatory submissions.
• Strong knowledge of clinical drug development, pharmacokinetics, pharmacology, and PKPD methodologies.
• Expertise in R and SAS for dataset construction and analysis, with familiarity in CDISC ADaM/SDTM standards.
• Proven experience in multiple therapeutic areas and global regulatory contexts.
• Excellent verbal and written communication skills in English, with experience presenting technical findings to cross-functional teams.
• Strong project management skills, with the ability to deliver high-quality work under tight deadlines.
• Leadership experience, including supervising and mentoring PKPD or statistical programmers.
• Innovative mindset with a commitment to continuous learning and process improvement.
• Ability to work independently and collaboratively in cross-functional, multinational project teams.

Benefits

• Competitive salary and performance-based incentives.
• Flexible and supportive remote or hybrid work environment.
• Comprehensive health, dental, and vision insurance coverage.
• Opportunities for professional development, training, and career growth.
• Exposure to global drug development projects and regulatory submissions.
• Collaborative, inclusive, and innovation-driven work culture.
• Paid time off and flexible policies to support work-life balance.