Overview
In this role you drive clinical pharmacology for an expanding CNS RNAi portfolio, focusing on PK, PD, and PK/PD analyses to inform development and regulatory decisions. You will work across cross-functional teams to design studies, interpret data, and contribute to submissions and publications. You’ll operate in a matrixed environment, translating complex data into actionable insights that shape clinical programs and regulatory strategy. This is a virtual role based in The Netherlands or UK, offering an opportunity to impact next-generation RNAi therapies.
Responsibilities
- Represent and lead clinical pharmacology support for clinical stage project teams
- Analyze, interpret, and integrate clinical pharmacology data for reports
- Conduct PK and PK/PD analyses to guide development decisions
- Provide clinical pharmacology input for regulatory submissions (briefing documents, IND, CTA, NDA)
- Prepare sections of protocols, Investigator Brochures, and Clinical Study Reports related to Clinical Pharmacology
- Partner with Research, Bioanalytical, Clinical, Regulatory, Project Management and other R&D functions
- Prepare abstracts and manuscripts for publications
Key requirements
- Ph.D. in Pharmacokinetics, Pharmacometrics, or Clinical Pharmacology (or Pharm.D.) with pharma/biotech industry experience
- In-depth knowledge of clinical pharmacology, PK, modeling and simulation, PK/PD, ADME, and clinical data interpretation
- Strong knowledge of international Clinical Pharmacology and Pharmacometrics guidelines
- Proficiency in Phoenix WinNonlin, R, NONMEM, or equivalent PK/modeled data visualization software
- Ability to function in and contribute to a highly matrixed team
- Ability to work independently and communicate effectively
- Fluency in English (spoken and written)
- Strong communication and presentation skills
- Excellent interpersonal abilities
- Independent work style
- PK/PD analysis
- Pharmacokinetic modeling and simulation
- ADME interpretation
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