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SVP, Head of Clinical Pharmacology, QSP & Translational Sciences
BioCryst Pharmaceuticals, Inc.Senior Vice President & Head of Clinical Pharmacology, QSP & Translational Sciences at BioCryst. Leading innovative drug development strategies and integrating AI in clinical decision-making.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Pharmacology and Pharmacometrics, with a strong focus on leading drug development strategies and regulatory submissions. Proven ability to integrate AI and machine learning into clinical decision-making and build high-performing global teams.
Highest-signal resume keywords
PhD In Clinical PharmacologyLeadership In Clinical PharmacologyRegulatory Submissions And ApprovalsQuantitative Systems PharmacologyExperience In Rare Disease Drug Development
ATS Keywords
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Hard Skills
Dose SelectionDose OptimizationExposure-Response AnalysesDrug-Drug Interaction StrategiesModel-Informed Drug DevelopmentMechanistic Modeling ApproachesAI-Enabled Drug DevelopmentClinical Pharmacology StrategyTranslational MedicineBiomarker Strategy
Soft Skills
CollaborationLeadershipStrategic ThinkingCommunicationTeam Building
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryRegulatory AgenciesFDAEMATranslational SciencesClinical DevelopmentBiometricsData SciencesTherapeutic Area Experience
Tech Stack
Tools & technologiesQt
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities