Global Head, Clinical Pharmacology & Modeling

Keros Therapeutics, Inc.; Lexington (MA); On-site; USD 221,000 - 250,000; Full time

Job summary

Keros Therapeutics, Inc. is seeking a Senior Director, Clinical Pharmacology to provide strategic leadership for PK, PD, and MIDD across our R&D portfolio.

The role leads modeling and simulation activities from pre-IND through early clinical phases and global trials, coordinating cross-functional teams and regulatory interactions. You will oversee NCA, population PK/PK-PD, exposure–response analyses, and trial simulations; manage external CROs and pharmacometrics vendors; mentor junior

Qualifications

• An advanced degree (Ph.D., Pharm.D., or M.D.) in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, Pharmacometrics, or a highly quantitative scientific discipline
• Minimum of 8 to 10+ years of direct pharmaceutical or biotech industry experience specializing in clinical pharmacology, pharmacometrics, and drug development with a clear track record of increasing leadership responsibility

Responsibilities

• Define and lead global clinical pharmacology and quantitative M&S strategies for small molecules and biologics from pre-IND through Phase 2/3 and global submissions
• Serve as the clinical pharmacology SME on cross-functional program teams and influence pipeline and strategy through quantitative frameworks
• Independently perform and oversee NCA, population PK, PK/PD, exposure–response analyses and trial simulations to answer development questions
• Direct the design, execution, analysis, and reporting of clinical pharmacology protocols (e.g., ADME, DDI, BA/BE, special populations)
• Author, review, and defend regulatory components and represent Keros in FDA/EMA interactions
• Cultivate cross-functional partnerships across DMPK, Toxicology, Biology, Translational Medicine, Biometrics, Regulatory Affairs, Clinical Operations, and CMC
• Select, onboard, and manage CROs and pharmacometrics vendors to ensure timely, budget-conscious deliverables
• Lead ongoing optimization of internal clinical pharmacology and M&S platforms with new tools and SOPs
• Supervise and develop junior scientists and quantitative modelers

Skills

Clinical pharmacology strategy

M&S leadership

NCA analyses

Population PK/PK-PD

Regulatory submissions

Cross-functional collaboration

Vendor management

MIDD

DMPK collaboration

Education

Ph.D./Pharm.D./M.D. in Pharmaceutical Sciences or related

Tools

Phoenix WinNonlin

SAS

Python

Julia

MATLAB

Job description

Keros Therapeutics, Inc. is seeking a Senior Director, Clinical Pharmacology to provide strategic leadership for PK, PD, and MIDD across our R&D portfolio.

The role leads modeling and simulation activities from pre-IND through early clinical phases and global trials, coordinating cross-functional teams and regulatory interactions. You will oversee NCA, population PK/PK-PD, exposure–response analyses, and trial simulations; manage external CROs and pharmacometrics vendors; mentor junior