Senior Manager, Clinical Pharmacology Lead - Gene Therapy

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

Benefits offered by this job

Bonus

Equity

Job summary

CRISPR Therapeutics, a leading gene-editing biopharmaceutical company, is seeking a Clinical Pharmacology Lead to advance dosing strategies and PK/PD analyses for novel gene therapies. You will drive IND-to-late stage development, manage CROs, and ensure GLP/GCLP compliance while collaborating with cross-functional teams in a fast-paced environment.

The role emphasizes clinical pharmacology strategy, assay development, regulatory submissions, and data interpretation, with travel up to ~10%.

Qualifications

• BS in pharmacology 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.
• Working knowledge of clinical trial operations.
• Prior experience coordinating and managing external 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 travel, approximately 10%.

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 by integrating nonclinical, translational, and emerging clinical data, including first-in-human dosing and dose optimization.
• Design PK, PD, and biomarker sampling strategies for clinical protocols with cross-functional partners.
• Collaborate with clinical operations and sample operations to inform sample journey plans and create clinical laboratory manuals.
• Translate program needs into a portfolio of clinical assays and vendor strategies with discovery/pre-clinical scientists and CROs.
• Manage CROs and vendors supporting clinical pharmacology work, including assay development and transfer.
• Monitor GLP/GCLP validation of assays at CROs and review documentation for multiple projects.
• Ensure assay validation and sample analyses meet regulatory standards (FDA/EMA/ICH/WHO/GLP/GCLP/ISO).
• Work with data management and biostatistics to ensure timely data transfer.
• Conduct noncompartmental analyses, population PK/PD modeling, and exposure–response analyses.
• Assess immunogenicity impact on PK/PD/safety/efficacy.
• Prepare and review content for publications, regulatory submissions, SAPs, and study reports.

Skills

NCA (Phoenix WinNonlin)

Population modeling (NONMEM, Monolix,R

Bioanalytical assay knowledge

Clinical trial operations

CRO management

Excellent communication

Independent, fast-paced work

Education

Bachelor's degree in pharmacology or related field

Tools

qPCR

ELISA

MSD

Luminex

HPLC

Job description

CRISPR Therapeutics, a leading gene-editing biopharmaceutical company, is seeking a Clinical Pharmacology Lead to advance dosing strategies and PK/PD analyses for novel gene therapies. You will drive IND-to-late stage development, manage CROs, and ensure GLP/GCLP compliance while collaborating with cross-functional teams in a fast-paced environment.

The role emphasizes clinical pharmacology strategy, assay development, regulatory submissions, and data interpretation, with travel up to ~10%.