Lead and conduct population PK analyses using advanced modeling tools and methodologies
Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
Author and review PK reports and clinical pharmacology sections of regulatory documents
Represent clients in regulatory interactions and contribute to business development and relationship management
Requirements
Life science, healthcare and/or business degree
Minimum 6-10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics
Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions
Proficiency in NONMEM, Pirana, and R software preferred
Excellent organizational, negotiating and financial skills
Benefits
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees