Sr. Manager, Translational Modeling

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 using mechanistic approaches (PK, PBPK, PK/PD, QSP) to support candidate selection, progression, and key development decisions. Provides oversight and review of regulatory documentation supporting IND, NDA, BLA, and other submissions.

Essential Duties & Responsibilities
- Lead development of mechanistic modeling strategy from discovery through early development/clinical, focused on biologics and protein therapeutics.
- Design, implement, calibrate, validate, and document mechanistic modeling approaches addressing MIDD questions across programs.
- Develop PBPK, PK/PD, QSP, and mechanistic pathway models with scientific rigor.
- Drive translational modeling strategies for discovery and early development decision-making.
- Integrate in vitro, in vivo, and emerging datasets into robust translational models.
- Collaborate with DMPK, toxicology, bioanalytical, biology, and clinical pharmacology.
- Present strategies, results, and recommendations to guide program discussions.
- 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.
- Implement best practices for modeling workflows; ensure high-quality, reproducible outputs.
- Evaluate and apply emerging methodologies including AI/ML.
- Coordinate modeling deliverables across programs to meet timelines and quality expectations.
- Support external scientific engagement via publications and conference presentations.

Experience & Qualifications
- PhD in systems biology, engineering, biochemistry, physics, applied mathematics, bioinformatics, or scientific computing.
- 5+ years pharma/biotech experience with significant translational modeling experience.
- Strong scientific computing/programming skills; preference for Matlab/SimBiology.
- Extensive experience developing/applying mechanism-based mathematical models.
- Proven MIDD experience, especially PBPK and QSP across multiple programs with impact on program cadence/success.
- Strong translational science and drug development knowledge (pharmacometrics, pharmacology, pharmacodynamics, toxicology, bioanalytics).
- Demonstrated ability to guide program decisions using modeling and simulation.
- Track record using modeling to guide experimental design for modality-driven target hypotheses.
- Strong analytical, problem-solving, and data interpretation skills.
- Excellent written and oral communication; ability to influence cross-functional teams.

Preferred Qualifications
- Experience across multiple therapeutic areas, modalities, and delivery routes.
- Experience contributing to regulatory submissions (e.g., IND, briefing documents).
- Experience leveraging/evaluating AI/ML in modeling workflows.
- Established publication record.
- Experience with external partners, vendors, or collaborations.