Director, Pharmacometrics

About the role

Step into a role where science meets strategy and your expertise shapes the future of drug development. As a Director, Pharmacometrician, you’ll lead high-impact modeling and simulation efforts within a dynamic Clinical Pharmacology, Modeling and Simulation (CPMS) environment. You’ll guide teams, mentor pharmacometricians, and provide strategic insight to clients at key development milestones. This role also offers the opportunity to represent clients in interactions with regulatory agencies. If you thrive on collaboration and solving complex scientific challenges, this is your chance to make a meaningful impact.

Responsibilities

• 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 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

Disclaimers

Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within a reasonable distance from one of our global offices.