Senior Manager, Translational Modeling

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Deliver expert mathematical modeling to spearhead the development of a mechanistic modeling strategy for drug discovery and early development through clinical phases, with a strong emphasis on biologics and protein therapeutics.

• Oversee the design, implementation, calibration, validation, and documentation of mechanistic modeling approaches to address MIDD questions across various programs.

• Create PBPK, PK/PD, QSP models, and mechanistic pathway models, ensuring scientific rigor and consistency throughout.

• Propel translational modeling strategies to facilitate decision-making in discovery and early development.

• Synthesize data from diverse sources (in vitro, in vivo, and emerging datasets) to construct robust translational models.

• Collaborate closely with cross-functional stakeholders (DMPK, toxicology, bioanalytical, biology, clinical pharmacology) to ensure alignment and effectiveness of modeling strategies.

• Present modeling strategies, results, and recommendations to cross-functional teams and guide program discussions effectively.

• Advise on study design and data generation strategies to optimize translational value.

• Author and review modeling components of regulatory documents (e.g., IND-enabling packages, briefing materials) and provide support for regulatory interactions as necessary.

• Advocate for and implement best practices in modeling workflows, ensuring high-quality and reproducible outputs.

• Assess and apply emerging methodologies, including AI/ML, to enhance modeling capabilities.

• Coordinate modeling deliverables across assigned programs, ensuring timelines and quality expectations are achieved.

• Contribute to external scientific engagement through publications and conference presentations.

⛳️ Requirements

• PhD in systems biology, chemical, mechanical or biomedical engineering, biochemistry, physics, applied mathematics, bioinformatics, or scientific computing.

• A minimum of 5 years of experience in the pharma/biotech industry with substantial experience in translational modeling.

• Strong proficiency in scientific computing and programming, with a strong preference for Matlab/SimBiology.

• Extensive experience in developing and applying mechanism-based mathematical models of biological systems.

• Proven experience with MIDD approaches, particularly with PBPK and QSP modeling workflows across multiple programs, demonstrating a track record of translational modeling influencing program cadence and success.

• Strong understanding of translational science and drug development from discovery through early development, including related disciplines (pharmacometrics, pharmacology, pharmacodynamics, toxicology, bioanalytics).

• Demonstrated ability to contribute to and guide program-level decision-making using modeling and simulation techniques.

• Proven history of utilizing modeling and simulation to inform experimental design specific to modality-driven target hypotheses.

• Strong analytical, problem-solving, and data interpretation skills.

• Excellent written and oral communication abilities, capable of influencing cross-functional teams.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Professional development opportunities