Sr. Manager, Translational Modeling
BioCryst Pharmaceuticals, Inc.
August 06, 2026
Remote friendly (North Carolina, United States)
United States
Clinical Research and Development
Job Summary
The Sr. Manager, Translational Modeling, leads translational modeling efforts across several programs within the Nonclinical and Translational Sciences department. Develops and executes modeling strategies supporting discovery and development, applying mechanistic approaches such as PK, PBPK, PK/PD, and QSP to inform candidate selection and progression and key development decisions. Oversees and reviews regulatory documentation supporting IND, NDA, BLA, and other submissions.
Essential Duties & Responsibilities
- Provide mathematical modeling to lead mechanistic modeling strategy for drug discovery through clinical development, with focus on biologics and protein therapeutics.
- Lead design, implementation, calibration, validation, and documentation of mechanistic modeling approaches to address MIDD questions.
- Develop PBPK, PK/PD, QSP, and mechanistic pathway models with scientific rigor and consistency.
- Drive translational modeling strategies for discovery and early development decisions.
- Integrate in vitro, in vivo, and emerging datasets to build robust translational models.
- Collaborate with DMPK, toxicology, bioanalytical, biology, and clinical pharmacology; present recommendations to cross-functional teams.
- Guide study design and data generation to maximize translational value.
- Author/review modeling components of regulatory documents (e.g., IND-enabling packages, briefing materials) and support regulatory interactions.
- Promote best practices for modeling workflows; ensure high-quality, reproducible outputs.
- Evaluate and apply emerging methodologies, including AI/ML.
- Coordinate modeling deliverables across programs; contribute via publications and conferences.
Experience & Qualifications
- PhD in systems biology, engineering, biochemistry, physics, applied mathematics, bioinformatics, or scientific computing.
- 5+ years pharma/biotech with significant translational modeling experience.
- Strong scientific computing/programming skills; preference for Matlab/SimBiology.
- Extensive mechanism-based mathematical modeling experience.
- Proven MIDD experience using PBPK and QSP across multiple programs.
- Strong understanding of translational science/drug development (pharmacometrics, pharmacology, pharmacodynamics, toxicology, bioanalytics).
- Ability to guide program decisions using modeling and simulation.
- Track record using M&S to guide experimental design for modality-driven target hypotheses.
- Strong analytical, problem-solving, data interpretation skills; excellent written/oral communication.
Preferred Qualifications
- Experience across therapeutic areas, modalities, and delivery routes.
- Experience contributing to regulatory submissions (e.g., IND, briefing documents).
- Experience with/evaluating AI/ML in modeling workflows.
- Publication record.
- Experience with external partners, vendors, or collaborations.
The Sr. Manager, Translational Modeling, leads translational modeling efforts across several programs within the Nonclinical and Translational Sciences department. Develops and executes modeling strategies supporting discovery and development, applying mechanistic approaches such as PK, PBPK, PK/PD, and QSP to inform candidate selection and progression and key development decisions. Oversees and reviews regulatory documentation supporting IND, NDA, BLA, and other submissions.
Essential Duties & Responsibilities
- Provide mathematical modeling to lead mechanistic modeling strategy for drug discovery through clinical development, with focus on biologics and protein therapeutics.
- Lead design, implementation, calibration, validation, and documentation of mechanistic modeling approaches to address MIDD questions.
- Develop PBPK, PK/PD, QSP, and mechanistic pathway models with scientific rigor and consistency.
- Drive translational modeling strategies for discovery and early development decisions.
- Integrate in vitro, in vivo, and emerging datasets to build robust translational models.
- Collaborate with DMPK, toxicology, bioanalytical, biology, and clinical pharmacology; present recommendations to cross-functional teams.
- Guide study design and data generation to maximize translational value.
- Author/review modeling components of regulatory documents (e.g., IND-enabling packages, briefing materials) and support regulatory interactions.
- Promote best practices for modeling workflows; ensure high-quality, reproducible outputs.
- Evaluate and apply emerging methodologies, including AI/ML.
- Coordinate modeling deliverables across programs; contribute via publications and conferences.
Experience & Qualifications
- PhD in systems biology, engineering, biochemistry, physics, applied mathematics, bioinformatics, or scientific computing.
- 5+ years pharma/biotech with significant translational modeling experience.
- Strong scientific computing/programming skills; preference for Matlab/SimBiology.
- Extensive mechanism-based mathematical modeling experience.
- Proven MIDD experience using PBPK and QSP across multiple programs.
- Strong understanding of translational science/drug development (pharmacometrics, pharmacology, pharmacodynamics, toxicology, bioanalytics).
- Ability to guide program decisions using modeling and simulation.
- Track record using M&S to guide experimental design for modality-driven target hypotheses.
- Strong analytical, problem-solving, data interpretation skills; excellent written/oral communication.
Preferred Qualifications
- Experience across therapeutic areas, modalities, and delivery routes.
- Experience contributing to regulatory submissions (e.g., IND, briefing documents).
- Experience with/evaluating AI/ML in modeling workflows.
- Publication record.
- Experience with external partners, vendors, or collaborations.