Director, Translational Pharmacokinetics – DMPK

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

📋 Description

• Create and validate physiologically based pharmacokinetic (PBPK) models to simulate drug absorption, distribution, metabolism, drug-drug interactions, and excretion (ADME/DDI).

• Develop and advance pharmacokinetic and pharmacodynamic (PKPD) models utilizing nonclinical and clinical data.

• Assist with first-in-human (FIH) dose projections for drug candidates entering clinical development.

• Analyze nonclinical and clinical data while integrating various experimental data into models.

• Prepare simulation reports and evidence-based documentation to support regulatory decisions and submissions, including INDs, CTAs, IBs, briefing documents, regulatory responses, and materials for health authority meetings.

• Engage in regulatory interactions and preparation activities.

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

• Contribute insights into in vitro and in vivo study designs for model development.

• Perform DDI simulations and optimize dosing strategies under various physiological conditions.

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

• Assess emerging scientific 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 across the portfolio.

⛳️ Requirements

• PhD, PharmD, or a comparable advanced scientific degree.

• Over 12 years of industry experience in the modeling and simulation of PBPK and PKPD models, along with FIH dose projections.

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

• Strong understanding of ADME principles.

• Proficient in pharmacokinetic modeling software such as Simcyp, GastroPlus, Phoenix WinNonlin, and NONMEM.

• Capability to critically assess experimental data for model input.

• Ability to excel in a highly collaborative, matrixed biotechnology environment.

• Experience in supporting programs related to CNS, neuroscience, rare diseases, or sleep-wake disorders.

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

• Experience in advancing programs from candidate selection through to clinical development.

• Experience in managing CRO networks and outsourced development efforts.

• Strategic thinking and strong scientific judgment.

• Exceptional communication and influencing abilities.

• Cross-functional leadership experience.

• Strong project and risk management skills.

• Ability to balance scientific rigor with operational execution.

• Collaborative and hands-on leadership approach.

• Adaptability and quick learning capabilities.

🏝️ Benefits

• Company bonus based partially on individual and company performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent care flexible spending accounts.

• Life insurance and death benefits.

• Time-off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and various employee clubs and activities.

• Employee resource groups and support networks.