Boston-Based Clinical Pharmacology Lead — Senior Manager

Crispr Therapeutics AG; Boston (MA); Hybrid; USD 135,000 - 150,000; Full time

Benefits offered by this job

Bonus potential

Equity

Job summary

CRISPR Therapeutics in Boston is seeking a Clinical Pharmacology Lead to guide dose selection, PK/PD analyses, and regulatory-ready submissions for gene therapies. This hands-on role includes assay strategy, data integration, and CRO oversight to deliver robust clinical programs.

You will lead cross-functional teams, drive dose decisions, ensure GLP/GCLP compliance, and mentor staff while communicating findings to governance bodies. Travel ~10% is required.

Qualifications

• BS in pharmacology or related field with 10+ years of industry clinical pharmacology experience.
• Hands-on proficiency with NCA and population modeling approaches.
• Knowledge of bioanalytical techniques, assay development and validation.
• Experience coordinating and managing CROs.
• Excellent oral and written communication skills.

Responsibilities

• Serve as the clinical pharmacology lead on cross-functional program teams from IND through later-stage development.
• Drive dose selection and justification by integrating nonclinical and clinical data, including first-in-human dosing.
• Design PK/PD sampling strategies for clinical protocols with relevant partners.
• Collaborate with clinical operations and laboratories to ensure proper sample journeys and SOPs.
• Manage CROs and vendors, including assay development and validation, ensuring quality and timelines.
• Monitor GLP/GCLP validation of assays and review documents for multiple projects.
• Interpret data and provide actionable recommendations to governance bodies; author regulatory content.
• Travel up to 10% as needed.

Skills

NCA (Phoenix WinNonlin)

Population PK/PD modeling

Nonclinical data integration

Cross-functional collaboration

Independent work

Education

BS in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, or related field

PhD, PharmD or equivalent (preferred)

Tools

Phoenix WinNonlin

NONMEM

Monolix

R

qPCR

NGS

ELISA

HPLC

Job description

CRISPR Therapeutics in Boston is seeking a Clinical Pharmacology Lead to guide dose selection, PK/PD analyses, and regulatory-ready submissions for gene therapies. This hands-on role includes assay strategy, data integration, and CRO oversight to deliver robust clinical programs.

You will lead cross-functional teams, drive dose decisions, ensure GLP/GCLP compliance, and mentor staff while communicating findings to governance bodies. Travel ~10% is required.