Associate Director Preclinical & Translational PK/PD

About the role

The Associate Director of Translational/Preclinical Modeling develops and implements quantitative and mechanistic PK/PD models to aid in the understanding of target biology, therapeutic modality selection/optimization, and contributes to early clinical trial dose selection and/or design and advancement and strategic direction of modeling and simulation sciences.

Responsibilities

• Independently develops and implements quantitative and mechanistic mathematical PK/PD models that inform preclinical-to-early clinical translation, including human efficacious dose predictions and first-in-human dose selection.
• Actively contributes to the advancement and strategic direction of modeling and simulation sciences.
• Provides expert support to pre-clinical PK/PD project representatives and R&D project teams to design, execute and interpret in vitro and in vivo quantitative pharmacology studies.
• Effectively integrates and summarizes modeling and simulation analyses into useable information for multidisciplinary project teams.
• Remains apprised of emerging science and literature, and effectively collaborates with subject matter experts in Clinical Pharmacology, Quantitative Pharmacology and R&D to advance modeling and simulation sciences.
• Presents work at internal/external scientific meetings and publishes work in scientific journals.

Requirements

• Experience using one or more modeling and simulation platforms (e.g., Phoenix NLME, NONMEN, Monolix, ADAPT, MATLAB, SimBiology, etc.).
• Strong theoretical and practical foundation in pharmacokinetics, including non-compartmental, compartmental, PK/PD and PBPK.
• Effective work in a fast-paced, highly-matrixed team-based environment and leverage scientific reasoning to influence key stakeholders.
• Ability to learn new areas of biological sciences to develop quantitative and mechanistic PK/PD models for emerging therapeutic modalities.
• Familiarity with biotherapeutic modalities, including monoclonal and bispecific antibodies, gene therapy, CAR-T, siRNAs and other targeting agents preferred.

Qualifications

• Ph.D. or M.S. in pharmacokinetics, pharmaceutical sciences, engineering, applied mathematics or related disciplines.
• Greater than 6 years of pharmaceutical industry or related experience in developing and applying mechanism-based PK/PD models to guide R&D teams from early discovery to IND-stage clinical development.

Skills

• Expertise in modeling and simulation platforms.
• Strong theoretical and practical foundation in pharmacokinetics.
• Ability to learn new areas of biological sciences.
• Familiarity with biotherapeutic modalities.

Benefits

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Family support benefits.

Pay

$176,100.00 - $287,300.00 annually

Schedule

Not specified