Lead Clinical Pharmacology, Gene Therapy | Senior Manager

CRISPR Therapeutics; Boston (MA); Híbrido; USD 135.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

On-site lab facilities

Descripción de la vacante

CRISPR Therapeutics is seeking a Clinical Pharmacology Lead to join our Clinical Development team. This hands-on role covers strategy, dose selection, PK/PD analysis, and bioanalytical assay development, with CRO management and regulatory submission support.

The successful candidate will guide clinical pharmacology from IND through later-stage development, ensuring GMP compliance and timely data delivery to trials and publications.

Formación

• BS in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, or related field with 10+ years of industry clinical pharmacology experience.
• Hands-on proficiency with NCA and population modeling approaches.
• Working knowledge of bioanalytical techniques, assay development and validation.
• Working knowledge of clinical trial operations principles.
• Experience coordinating and managing external CRO projects.
• Excellent oral and written communication skills.
• Ability to work independently and collaboratively in a fast-paced team.
• Ability to travel, if required (~10%).

Responsabilidades

• Serve as clinical pharmacology lead on cross-functional program teams from IND through later-stage development.
• Drive dose selection by integrating nonclinical and clinical data, including first-in-human dosing and escalation.
• Design PK/PD and biomarker sampling strategies for protocols with cross-functional partners.
• Collaborate with operations to inform sample journey plans and clinical lab manuals.
• Translate program needs into a portfolio of clinical assays and vendor strategies.
• Manage CROs and vendors: assay development, transfer, validation, and data analysis.
• Ensure GLP/GCLP compliance and timely documentation for regulatory submissions.
• Stay current on regulatory guidance and gene therapy pharmacology practices.

Conocimientos

NCA Phoenix WinNonlin

Population modeling

Bioanalytical techniques

Clinical trials operations

CRO management

Communication skills

Independent work

Travel willingness

Educación

BS in pharmacology or related field

PhD/PharmD preferred

Herramientas

Phoenix WinNonlin

NONMEM

Monolix

R

Descripción del empleo

CRISPR Therapeutics is seeking a Clinical Pharmacology Lead to join our Clinical Development team. This hands-on role covers strategy, dose selection, PK/PD analysis, and bioanalytical assay development, with CRO management and regulatory submission support.

The successful candidate will guide clinical pharmacology from IND through later-stage development, ensuring GMP compliance and timely data delivery to trials and publications.