Associate Director, Pharmacometrician

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and perform population pharmacokinetic analyses utilizing advanced modeling tools and techniques.

• Create and execute innovative strategies to improve the efficiency and precision of pharmacokinetic analysis.

• Design, assess, and interpret clinical pharmacology studies (including renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) while providing insights to optimize pharmacokinetic sampling and dosing strategies.

• Offer strategic guidance to clients, taking ownership of deliverables and developing clinical pharmacology plans.

• Write and review pharmacokinetic reports and clinical pharmacology sections of regulatory documents.

• Represent clients during regulatory interactions and participate in business development and relationship management efforts.

⛳️ Requirements

• Degree in life sciences, healthcare, and/or business.

• A minimum of 6-10 years of relevant experience, including expertise in drug development, clinical pharmacology, and pharmacometrics.

• Essential regulatory experience, including regulatory report writing. Experience with regulatory submissions such as INDs, CTAs, regulatory meetings, and NDA/BLA/MAA submissions is required.

• Proficient in NONMEM, Pirana, and R software is preferred.

• Strong organizational, negotiation, and financial skills.

🏝️ Benefits

• Comprehensive benefits package tailored to each location.

• Competitive salaries based on location.

• Departmental Study/Training Budget to support professional development.

• Flexible working hours (within reason).

• Opportunities for remote/hybrid working based on location.

• Leadership and mentoring prospects.

• Involvement in our enriching Buddy Program as a new or existing employee.

• Internal growth opportunities and career advancement.

• Financially rewarding internal employee referral program.

• Access to online soft-skills and technical training through internal platforms.

• Eligibility for our Spot Bonus Award Program to recognize outstanding contributions to projects.

• Eligibility for our Loyalty Award Program to acknowledge the dedication of long-serving employees.