Clinical Pharmacology Lead & Senior Manager — Hybrid & Equity

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

Ventajas ofrecidas por este puesto de trabajo

Remote work flexibility

On-site collaboration

Descripción de la vacante

CRISPR Therapeutics, Inc. in Boston, MA seeks a Clinical Pharmacology Lead to shape strategy from IND through late-stage development for novel gene therapies.

You will own pharmacology plans, drive dose justification, and collaborate across discovery, clinical operations, and regulatory teams. The ideal candidate has 10+ years in clinical pharmacology, expertise in PK/PD modeling, and a strong regulatory mindset.

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 (e.g., Phoenix WinNonlin) and population modeling approaches (e.g., NONMEM, Monolix, R).
• Working knowledge of bioanalytical techniques, assay development and validation.
• Excellent oral and written communication skills.
• Ability to travel up to 10%.

Responsabilidades

• Serve as the clinical pharmacology lead on cross‑functional program teams, owning strategy 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 clinical protocols with cross-functional partners.
• Collaborate with operations to inform sample journey plans and lab manuals.
• Translate program needs into clinical assays and vendor strategies.
• Manage CROs and vendors for assay development, transfer, validation, and data analysis.
• Monitor GLP/GCLP validation at CROs and ensure timely document reviews.
• Ensure assay validation and analyses meet regulatory standards (FDA/EMA/ICH/WHO).
• Work with data management to ensure timely data transfer.
• Conduct noncompartmental analyses, population PK/PD modeling, and exposure–response analyses.
• Assess immunogenicity impact on PK/PD/safety/efficacy.
• Communicate actionable recommendations to teams and governance bodies.
• Author and review regulatory content and publication materials.
• Manage critical project deadlines and outsourcing of complex assays.
• Stay current on gene therapy pharmacology and departmental best practices.

Conocimientos

NCA analysis

Population PK/PD modeling

Bioanalytical techniques

Regulatory understanding

Educación

BS in pharmacology or related field

PhD/PharmD preferred

Herramientas

Phoenix WinNonlin

NONMEM

Monolix

R

Descripción del empleo

CRISPR Therapeutics, Inc. in Boston, MA seeks a Clinical Pharmacology Lead to shape strategy from IND through late-stage development for novel gene therapies.

You will own pharmacology plans, drive dose justification, and collaborate across discovery, clinical operations, and regulatory teams. The ideal candidate has 10+ years in clinical pharmacology, expertise in PK/PD modeling, and a strong regulatory mindset.