Executive Director, Clinical Pharmacology/Pharmacometrics

🕒 September 25

🇺🇸 United States – Remote

💵 $261.8k - $346.1k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Recursion

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

💰 $150M Post-IPO Equity on 2022-10

Healthcare • Manufacturing • Consulting

Recursion is a pioneering biopharmaceutical company that leverages advanced technology to drive the industrialization of drug discovery. It combines hardware, software, and vast datasets to decode complex biological information, aiming to create a next-generation platform for developing therapeutics. With a focus on AI and collaboration with industry leaders like Exscientia, Recursion is at the forefront of TechBio, transforming the landscape of drug discovery and development. The company is a proud founding member of BioHive, underscoring its commitment to innovation and leadership in the life sciences sector. Operating with over 60 petabytes of proprietary data and a significant pipeline, Recursion aims to radically improve lives by exploring broad therapeutic areas in partnership with other entities.

📋 Description

• Lead clinical pharmacology and pharmacometrics strategy and execution for rare disease and oncology clinical programs • Develop clinical pharmacology and pharmacometric strategies supporting product development plans • Serve as Clinical Pharmacology lead for programs in clinical development and representative for regulatory interactions • Perform and/or oversee modeling and simulation to solve drug development questions and expedite decision making • Provide clinical pharmacology input on Phase 1–3 clinical study designs and dedicated Phase 1 clinical pharmacology studies • Author and review clinical pharmacology sections for Investigator's Brochures, INDs, NDAs, and other regulatory submissions • Act as clinical pharmacology expert during interactions with health authorities • Collaborate with clinical study, translational, preclinical, and due diligence teams • Work with clinical development functions and discovery functions across end-to-end projects

🎯 Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or related discipline, M.D with a Clinical Pharmacology expertise, or a Pharm D. with a Clinical Pharmacology fellowship • 10+ years of experience in biotech/pharmaceutical drug development • Demonstrated success leading all clinical pharmacology related aspects of drug development • Ability to manage PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations • Proficiency with WinNonlin, Monolix, NONMEM, R or other modeling software • Demonstrated experience responding to regulatory agency questions, preparing clinical pharmacology aspects of regulatory submissions and attending regulatory meetings • Experience in oncology is preferred, but not an absolute requirement

🏖️ Benefits

• Annual bonus • Equity compensation • Comprehensive benefits package • Required periodic travel • Accommodations available on request for candidates taking part in all aspects of the selection process

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