SVP, Head of Clinical Pharmacology, QSP & Translational Sciences

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🔥 56 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🔴 Lead

🌎 Translator / Interpreter

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• Serve as a strategic member of the R&D Leadership Team and contribute to portfolio prioritization, governance, business development evaluations, and overall R&D strategy • Build and lead a world-class organization encompassing Clinical Pharmacology, Pharmacometrics, Quantitative Systems Pharmacology, Translational Medicine, Biomarker Strategy, Model-Informed Drug Development, Computational and AI-enabled Drug Development Sciences • Define and execute the company's global Clinical Pharmacology strategy across all development programs • Lead dose selection, dose optimization, exposure-response analyses, QT assessments, special population evaluations, drug-drug interaction strategies, and regulatory clinical pharmacology packages • Develop and implement innovative Quantitative Systems Pharmacology and mechanistic modeling approaches • Partner closely with Research, Clinical Development, Regulatory Affairs, Biometrics, and Medical Affairs to create seamless translation from discovery through registration • Lead BioCryst's vision for integrating AI and machine learning into translational and clinical development decision-making • Collaborate closely with Clinical Development, Regulatory Affairs, Biometrics & Data Sciences, Research, Medical Affairs

🎯 Requirements

• PhD in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Systems Biology, Biomedical Engineering, Applied Mathematics, Computational Biology, Pharmaceutics, or a related scientific discipline • Minimum 15 years of progressive pharmaceutical or biotechnology industry experience • Significant leadership experience in Clinical Pharmacology, Pharmacometrics, Translational Sciences, QSP, or related disciplines • Demonstrated success supporting both early-stage and late-stage drug development programs • Extensive experience in rare disease drug development strongly preferred • Broad therapeutic area experience across multiple disease areas • Proven track record of successful regulatory submissions and approvals • Substantial experience interacting directly with global regulatory agencies, including FDA and EMA • Experience building and leading high-performing global teams • Demonstrated application of MIDD approaches that materially influenced development and regulatory decisions

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities