Director, Translational Pharmacokinetics – DMPK

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

📋 Description

• Develop and execute PBPK models that illustrate drug behavior within biological systems.

• Construct and refine PKPD models utilizing both nonclinical and clinical data.

• Assist in projecting first-in-human dosages for selected drug candidates.

• Combine pharmacokinetic and pharmacodynamic experimental data to enhance model precision.

• Supply evidence-based simulations for INDs, CTAs, IBs, briefing documents, regulatory responses, and materials for health authority meetings.

• Engage in regulatory interactions and preparation activities.

• Collaborate with DMPK, clinical pharmacology, translation sciences, CMC, clinical development, regulatory affairs, and project management teams.

• Contribute to the design of in vitro and in vivo studies.

• Perform simulations to forecast drug-drug interactions.

• Optimize dosing strategies across various physiological conditions.

• Support candidate selection and facilitate the transition of programs from research to development.

• Assess emerging scientific developments and competitive landscape information.

• Present program recommendations to senior leadership and governance committees.

• Mentor junior scientists and enhance organizational capabilities.

• Foster scientific rigor, innovation, and operational excellence throughout the portfolio.

⛳️ Requirements

• PhD, PharmD, or an equivalent advanced scientific degree.

• Over 12 years of industry experience in modeling and simulation of PBPK and PKPD models, as well as first-in-human dose projections.

• Proven experience in supporting IND-enabling programs and regulatory submissions.

• Strong understanding of ADME principles.

• Proficient in Simcyp, GastroPlus, Phoenix WinNonlin, and NONMEM.

• Ability to critically assess experimental data for model input.

• Capacity to thrive in a highly collaborative, matrixed biotechnology setting.

• Experience in supporting CNS, neuroscience, rare disease, or sleep-wake disorder programs.

• Familiarity with FDA, EMA, and ICH regulatory guidelines.

• Experience in progressing programs from candidate selection through clinical development.

• Experience managing CRO networks and outsourced development tasks.

• Strong scientific judgment.

• Excellent communication and influencing skills.

• Cross-functional leadership capabilities.

• Strong project and risk management skills.

• Ability to balance scientific rigor with operational execution.

• Collaborative, hands-on leadership approach.

• Adaptability and learning agility.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Prescription drug coverage.

• Healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Employee clubs and activities.