Overview
In this Director role, you drive high-impact population PK analyses and guide cross-functional teams in a CPMS setting. You shape study design, interpretation, and regulatory input while mentoring colleagues and engaging clients. You will represent clients in agency interactions and help grow business through strategic PK/PD insights. This is a hands-on leadership position at the forefront of pharmacometrics, with opportunities to influence regulatory documents and client strategy.
Pay / Benefits
- Comprehensive benefits package per location
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid working depending on location
- Leadership and mentoring opportunities
- Departmental study/training budget
- Internal growth opportunities and career progression
Responsibilities
- Lead population PK analyses using advanced modeling tools and methodologies
- Develop and implement innovative approaches to improve PK analysis efficiency and accuracy
- Design, analyze, and interpret clinical pharmacology studies and optimize sampling and dosing strategies
- Provide strategic guidance to clients, own deliverables, and develop clinical pharmacology plans
- Author and review PK reports and regulatory sections of documents
- Represent clients in regulatory interactions and contribute to business development and relationship management
Key requirements
- 6–10 years or more in drug development and pharmacometrics (conflicting wording in description resolved to 10+ years)
- Experience in regulatory report writing and regulatory submissions (INDs, CTAs, NDA/BLA/MAA)
- Proficiency in NONMEM, Pirana, and R
- Strong analytical thinking and client-focused leadership in fast-paced environments
- Excellent organizational, negotiating, and financial skills
- Background in life sciences, healthcare, or business
- leadership
- collaboration
- strong communication
- NONMEM
- Pirana
- R
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