VP, Clinical Pharmacology & Pharmacometrics — Remote

Recursion Pharmaceuticals

New York (NY)

Hybrid

USD 322,000 - 443,000

Full time

2 days ago

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Job summary

Recursion Pharmaceuticals is seeking a dynamic executive to lead Clinical Pharmacology, Pharmacometrics, and translational modeling from first-in-human planning to registrational development. You will shape dose strategy, drive quantitative development, and guide regulatory submissions with cross-functional teams.

The role demands10–15+ years in biotech/pharma, strong leadership, and a track record of influencing executives and regulators.

Qualifications

Advanced degree in clinical pharmacology, pharmacometrics, pharmaceutical sciences, quantitative pharmacology, biomedical engineering, medicine, pharmacy, or a related field; PhD, PharmD, or MD preferred.
15+ years of biotech or pharmaceutical industry experience, including significant leadership experience in Clinical Pharmacology, Pharmacometrics, Quantitative Pharmacology, or model-informed drug development.
Proven success leading clinical pharmacology strategy across multiple programs, ideally from first-in-human studies through registrational development, submission, and labeling.
Deep expertise in PK, PK/PD, exposure-response, exposure-safety, population PK, PBPK, QSP, dose optimization, dose justification, and model-based clinical trial design.
Experience designing, interpreting, and defending clinical pharmacology studies and analyses in support of global development and regulatory submissions.
Strong understanding of FDA, EMA, MHRA, PMDA, and ICH expectations for clinical pharmacology, pharmacometrics, dose selection, MIDD, and regulatory documentation.
Demonstrated ability to build and lead high-performing teams, influence senior stakeholders, manage external partners, and communicate complex quantitative concepts clearly to executives, program teams, partners, and regulators
Experience in oncology, rare disease, and/or small molecule development strongly preferred; experience applying AI, advanced analytics, or automation in clinical pharmacology is a plus

Responsibilities

Set the enterprise strategy for Clinical Pharmacology, Pharmacometrics, Translational Modeling, and preclinical-to-clinical quantitative integration across Recursion’s clinical and post-candidate nomination portfolio
Own dose strategy from first-in-human planning through registrational development, including dose escalation, dose optimization, exposure-response, safety, efficacy, and label-supporting dose justification
Lead quantitative development approaches, including population PK, PK/PD, exposure-response, PBPK, QSP, disease progression modeling, and clinical trial simulations
Design and oversee clinical pharmacology studies, including food effect, DDI, organ impairment, QT/cardiac safety, bioavailability/bioequivalence, mass balance/ADME, and special population studies
Partner cross-functionally with Clinical Development, Development Sciences, DMPK, Toxicology, Translational Modeling, Biomarkers, Regulatory, Biostatistics, CMC, and Data Science to inform development strategy and decision-making
Represent Recursion as the clinical pharmacology expert in regulatory interactions and ensure high-quality clinical pharmacology contributions to INDs/CTAs, briefing books, NDAs/BLAs/MAAs, regulatory responses, and labeling
Represent Clinical Pharmacology and Translational Modeling in cross-functional program teams, governance forums, regulatory interactions, and alliance settings with Recursion’s external pharma partners
Build, mentor, and scale a high-performing Clinical Pharmacology and Pharmacometrics function, including internal talent, consultants, CROs, and external modeling partners
Advance the responsible use of AI, automation, and advanced analytics to improve evidence integration, modeling workflows, and clinical development decisions