Senior Pharmacometrician

Company Overview

Clinical Dynamix is a leading biopharmaceutical company dedicated to developing innovative treatments for complex diseases. We are seeking a highly skilled and experienced Senior Pharmacometrician to join our dynamic Pharmacometrics team.

Job Summary

We are looking for a talented Pharmacometrics Lead to lead the planning, execution, and timely delivery of Model-Informed Drug Development (MIDD) and Pharmacometrics strategies and documents to support dose selection, clinical trial design, and regulatory submissions on assigned programs.

Key Responsibilities

• Represent the Pharmacometrics Group in multi-function matrix teams and serve as a subject matter expert.
• Lead the planning, execution, and timely delivery of MIDD and Pharmacometrics strategies and documents to support dose selection, clinical trial design, and regulatory submissions on assigned programs.
• Oversee the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of regulatory submissions.
• Independently conduct PK/PD analyses of data from Phase 1/2 studies and application of quantitative decision-making to assist in the characterization of population PK, dose- and exposure-response relationships to optimize subsequent clinical development.
• Communicate and interpret modeling results to project teams. Accountable for ensuring appropriate design and implementation of pharmacometrics plans.
• Collaborate with other colleagues to review and validate M&S outputs such as datasets and modeling programs.
• Prepare posters, publications, presentations for internal and external conferences.

Requirements

• MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a specific focus on PK and PK/PD modeling and simulation and 10+ years of Pharmaceutical/Biotech industry experience in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses.
• PharmD or PhD or equivalent preferred and 4+ years of relevant experience; may include postdoc experience.
• Demonstrated foundation of scientific knowledge (e.g., basic pharmacokinetic/pharmacodynamic [PK/PD] and pharmacology concepts) and technical pharmacometrics skills including but not limited to nonlinear mixed effect modeling, mechanistic PK/PD, physiologically-based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP) modeling and clinical trial simulations.
• Competent in using modeling tools for population PK, PD analysis (e.g., NONMEM, Monolix, Simcyp, R packages for nonlinear mixed-effects modeling).
• Proactive, innovative, with good problem-solving skills.
• Able to take different pharmacometrics assignments and deliver the results promptly.
• Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to cross-functional audiences.
• A critical thinker and quick learner with high engagement.
• Demonstrated experience and track record in clinical-stage drug development is a plus.
• Assimilates data and research findings outside of Company for application to new scientific projects.
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas.
• May develop an understanding of other areas and related dependencies.
• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools.
• Ability to work as part of and lead multiple teams.
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams.
• Excellent computer skills.
• Excellent communications, problem-solving, analytical thinking skills.
• Sees broader picture, impact on multiple programs, teams and/or departments.
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management skills.
• Ability to work in a cross-functional team and matrix environment.