Role Overview
Your main responsibilities will include, but are not limited to:
- Lead and perform population pharmacokinetic analyses using advanced modeling tools and methodologies
- Develop and implement innovative approaches to improve the efficiency and accuracy of pharmacokinetic analyses
- Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize PK sampling and dosing strategies
- Provide strategic advice to clients, assume responsibility for deliverables, and develop clinical pharmacology plans
- Write and review pharmacokinetic reports and the clinical pharmacology sections of regulatory documents
- Represent clients in interactions with regulatory authorities and contribute to business development and relationship management
Requirements
To succeed, we are looking for the following qualifications and attributes:
- Degree in life sciences, healthcare, and/or business administration
- At least 6 to 10 years of relevant professional experience, including drug development, clinical pharmacology, and pharmacometrics
- Regulatory experience, including preparation of regulatory reports, is essential. Experience with regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), regulatory meetings, and marketing authorization submissions (NDA/BLA/MAA)
- Proficiency with NONMEM, Pirana, and R is preferred
- Excellent organizational, negotiation, and financial management skills
Benefits
Benefits of working at Allucent include:
- Comprehensive benefits package by site
- Competitive salaries by site
- Departmental budget dedicated to training and study to support professional development
- Flexible working hours (where reasonable)
- Opportunity for remote/hybrid work depending on the site
- Leadership and mentoring opportunities
- Participation in our mentorship program for new and existing employees
- Opportunities for internal mobility and career progression
- Financially attractive employee referral program