Independently develops pre-clinical PK/PD and quantitative systems pharmacology models that enhance decision-making for NBE target and candidate selections and inform translational research strategies for NBEs.
Management of direct reports as needed including recruiting, onboarding and development; Mentors and develops scientific staff; Assigns projects, directs and oversees experimental design and results of technicians and junior level scientists.
Uses modeling and simulation to predict human efficacious dose/dose regimen and influences selection of first-in-human starting dose.
Designs quantitative pharmacology and pharmacokinetic studies, analyzes and interprets data, and clearly communicates results to teams and management.
Leverages literature data or proposes new experiments to validate models or test model-generated hypotheses.
Develops new methodologies, protocols, or procedures that contribute to core group/research goals and reflect expert knowledge.
Serves as the PK/PD modeling representative on multiple cross-functional project teams.
Effectively collaborates with scientists within and outside the functional area (e.g., therapeutic area biologists, protein engineering scientists, clinical pharmacologists).
Contributes to the overall translational research strategy by integrating PK/PD and target engagement considerations into team strategy and decision-making.
Prepares clear technical reports, publications, and oral presentations.
Develops broad knowledge in the field of expertise and enhances internal capabilities of the group.
Presents work at internal/external scientific meetings and publishes work in scientific journals.
Complies with all applicable regulations; Ensures that work performed in area of responsibility is conducted in a safe and compliant manner; Maintains proper records in accordance with SOPs and policies.
Contributes to departmental administration; Demonstrates fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travel.
Qualifications
Theoretical and practical knowledge of pharmacokinetics, PK/PD, and quantitative systems pharmacology modeling.
Experience using one or more commercially available modeling and simulation platforms (e.g., Phoenix/WinNonlin, NONMEM, MATLAB, SimBiology, etc.).
Experience in mechanism-based PK/PD modeling of therapeutic proteins is highly desired.
Proficiency with a scriptable modeling and simulation language (e.g., R, MATLAB, Julia).
Proficiency with PBPK (whole-body and minimal) modeling applied to biologics research and development.
Experience with computational tools used for validation and verification of mechanism-based models (e.g., parameter estimation, sensitivity analysis, virtual population/patient simulations).
Proven ability to manage and mentor scientific teams, fostering professional development and ensuring successful project delivery.
Strong aptitude for managing projects and sharing expertise with cross-functional and global teams.
Ability to build effective working relationships and influence others both inside and outside the department.
