Senior PBPK Modeler

What You'll do

• As a PBPK Modeler at Vial, you will play a critical role in predicting human pharmacokinetics (PK) and optimizing dosing strategies for our novel drug candidates across multiple modalities, including antibodies, small molecules, and oligonucleotides. You will work closely with cross-functional teams to integrate in vitro, preclinical, and clinical data into physiologically based pharmacokinetic (PBPK) models to support decision-making in drug development.

• We are looking for individuals who are deeply experienced in PBPK modeling, thrive in fast-paced environments, and can independently develop and validate models to guide clinical translation.

Key Responsibilities

• Develop and refine PBPK models to predict human PK for novel drug candidates using available in vitro and preclinical data.

• Compare and validate PBPK models using published clinical PK data from reference compounds to establish model credibility.

• Propose clinical dosing regimens based on PBPK model outputs, leveraging reference drug data for benchmarking.

• Analyze and interpret model predictions, identifying key parameters influencing drug exposure and clearance.

• Collaborate with internal scientists and external partners to integrate experimental data into PBPK modeling workflows.

• Address discrepancies between preclinical and human PK predictions, providing insights into factors driving variation.

• Incorporate variability (e.g., age, weight, genetics) into PBPK models, ensuring robustness of clinical predictions.

• Adapt modeling approaches for different drug modalities (antibodies, small molecules, oligonucleotides), considering key differences in ADME properties.

• Stay up to date on advancements in PBPK modeling, applying best practices and emerging methodologies.

Who You Are

• 5+ years of experience in PBPK modeling, preferably within a biotech or pharmaceutical setting.

• Expertise in modeling across multiple modalities, with a strong understanding of PK principles for antibodies, small molecules, and oligonucleotides.

• Proficiency in PBPK modeling software (e.g., Simcyp, GastroPlus, PK-Sim, Phoenix WinNonLin) and familiarity with programming languages such as R, Python, or MATLAB.

• Strong understanding of ADME properties and their impact on drug disposition.

• Experience with parameter estimation and model validation using clinical reference data.

• Ability to propose and justify clinical dosing regimens based on model outcomes.

• Excellent problem-solving skills and ability to work independently in a fast-paced environment.

• Strong communication and collaboration skills, with the ability to translate complex modeling results into actionable insights.

• Experience in multi-specific antibodies or extended half-life biologics.

• Understanding of small molecule PBPK modeling, including key input requirements and differences from mAb models.

• Prior experience supporting clinical trial design or regulatory submissions using PBPK models.

Why You’ll Love Working At Vial

Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved. This innate curiosity drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life.

Fostering autonomy. Autonomy is our guiding principle. We firmly believe that when team members are entrusted with autonomy, they unleash their true potential. Our culture fosters an environment where each individual takes ownership of their domain, empowering them to make a profound impact.

The pursuit of mastery. We are dedicated to cultivating mastery. We understand the value of honing expertise in a craft. The pursuit of mastery, coupled with a deep sense of pride in one's workmanship, fuels our unwavering commitment to tackle intricate challenges. At Vial, we foster a culture of highly autonomous professionals, each an expert in their field, collaborating on an immensely demanding endeavor together.

Move fast, stay humble. Our strength lies in agility and humility. We firmly believe that intellectual honesty and a nimble mindset are the pillars of success. By staying adaptable and open-minded to all solutions, we tackle obstacles head-on, remaining humble in the face of adversity. This enables us to surmount the hurdles that confront us at every twist and turn.

Benefits

• Competitive salary and equity compensation

• Generous paid time off and holidays

• Remote-first work environment with flexible schedules

• Company-provided laptop and home office setup stipend

• We prioritize candidate safety. Please be aware that official communication will only be sent from '@vial.com' or '@vial.careers' addresses. Vial is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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