Clinical Pharmacology Lead, Senior Manager

Position Summary

CRISPR Therapeutics is seeking a Clinical Pharmacology Lead to join us in developing novel gene therapies for serious diseases. This position will report into the Clinical Pharmacology Department, within Clinical Development. The successful candidate will have the opportunity to help answer the questions that shape how our medicines are dosed and developed. This hands-on role spans clinical pharmacology strategy, dose selection, PK/PD analysis, bioanalytical assay strategy, liaising with SMEs for technical development of assays, CRO management, timely data delivery in support of clinical trials, and authoring relevant sections of publication/regulatory submissions. This position requires knowledge of GxP method qualification and GxP-quality level method validation, and associated documentation in support of regulatory submissions.

Responsibilities

• Serve as the clinical pharmacology lead on cross-functional program teams, owning clinical pharmacology strategy from IND through later-stage development.
• Drive dose selection and justification by integrating nonclinical, translational, and emerging clinical data, including first-in-human dosing, dose escalation, and dose optimization.
• Design PK, PD, and biomarker sampling strategies for clinical protocols in partnership with clinical development, bioanalytical, and clinical operations colleagues.
• Collaborate with clinical operations and clinical sample operations to inform domestic and international sample journey plans and contribute to appropriate clinical laboratory manuals.
• Translate the needs of the clinical program into a portfolio of clinical assays and vendor strategies via collaboration with discovery/pre-clinical scientists, clinical scientists and commercial vendors.
• Select and manage CROs and vendors supporting clinical pharmacology work, including assay development, transfer, validation, and clinical sample analysis, ensuring quality and adherence to timelines.
• Monitor GLP/GCLP quality level method validation of assays at CROs by providing technical expertise and troubleshooting, and review of documents for multiple clinical projects simultaneously.
• Ensure that assay validation and sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (e.g., FDA, EMA, ICH, WHO, GLP/GCLP, and ISO).
• Work with clinical data management and biometrics to ensure appropriate and timely transfer of data.
• Conduct noncompartmental analyses, population PK/PD modeling, and exposure–response modeling.
• Assess the clinical impact of immunogenicity on PK, PD, safety, and efficacy.
• Interpret clinical pharmacology data and communicate it to program teams and governance bodies as clear, actionable recommendations.
• Author and review clinical pharmacology content for publications, public disclosures, and regulatory documents (e.g., INDs/CTAs, investigator’s brochures, briefing documents, clinical study reports, and BLA/MAA modules), as well as supporting reports and plans such as method development/validation reports, sample analysis reports, and SAPs.
• Manage critical project and program deadlines.
• Stay current on regulatory guidance and the science of cell and gene therapy clinical pharmacology, and contribute to departmental best practices.

Minimum Qualifications

• BS in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, or a related field, with 10+ years of industry clinical pharmacology experience.
• Hands-on proficiency with NCA (e.g., Phoenix WinNonlin) and population modeling approaches (e.g., NONMEM, Monolix, R).
• Working knowledge of bioanalytical techniques, assay development and validation.
• Working knowledge of the principles of clinical trial operations.
• Prior experience working in a biotechnology or pharmaceutical company coordinating and managing external projects at CROs.
• Excellent oral and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, cross-functional, results-oriented team environment.
• Ability to work within tight timelines for successful and timely execution of project and program goals.
• Financial management of projects.
• Ability to travel, if required (Approximately 10%).

Preferred Qualifications

• PhD, PharmD, or equivalent in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, or a related field, with 6+ years of industry clinical pharmacology experience.
• Working knowledge of assay development and validation across molecular (e.g., qPCR, NGS), protein (e.g., ELISA, MSD, Luminex, HPLC), and immunological (e.g., multiparameter flow cytometry, immunohistochemistry) platforms.
• Experience working in gene therapies.
• Experience contributing to a BLA or MAA submission.
• Familiarity with biomarker and immunogenicity strategy.