Senior Director, Clinical Pharmacology & M&S Strategy

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

Job summary

Keros Therapeutics Inc. in the United States seeks a Senior Director, Clinical Pharmacology to lead global PK/PD modeling, MIDD, and advanced quantitative strategies from pre-IND through NDA/BLA/MAA.

You will guide clinical pharmacology for small molecules and biologics, oversee external vendors, and collaborate across DMPK, Regulatory Affairs, Biostatistics, and Clinical Operations. This role requires an advanced degree and 8–10+ years in clinical pharmacology/pharmacometrics with a proven

Qualifications

• Advanced degree in pharmaceutical sciences or a highly quantitative discipline.
• 8–10+ years in clinical pharmacology/pharmacometrics/drug development in the pharma/biotech industry.
• Experience authoring regulatory submission documents (NDAs/BLAs/MAAs) and defending dosing strategies.
• Experience managing external vendors and cross-functional teams.

Responsibilities

• Define global clinical pharmacology and M&S strategies for small molecules and biologics from pre-IND to Phase 2/3.
• Serve as clinical pharmacology SME on cross-functional program teams and influence development strategies.
• Perform and oversee PK/PD, population PK, E-R analyses, and trial simulations to answer development questions.
• Design and analyze human ADME, DDI, food effect, BA/BE, and special populations studies.
• Authorship and defense of regulatory dossiers and regulatory interactions with FDA/EMA.
• Collaborate with internal stakeholders across DMPK, Toxicology, Biology, Translational Medicine, Biometrics, Regulatory Affairs, Clinical Operations, and CMC.
• Lead selection of CROs/consultants and manage external pharmacometrics vendors.
• Lead the optimization of internal clinical pharmacology/M&S platforms and SOPs.
• Mentor and develop junior scientists and modelers.

Skills

Clinical pharmacology

M&S strategies

PK/PD modeling

Regulatory submissions

Vendor management

Leadership

Cross-functional collaboration

Education

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

Tools

Phoenix WinNonlin

SAS

Python

MATLAB

Job description

Keros Therapeutics Inc. in the United States seeks a Senior Director, Clinical Pharmacology to lead global PK/PD modeling, MIDD, and advanced quantitative strategies from pre-IND through NDA/BLA/MAA.

You will guide clinical pharmacology for small molecules and biologics, oversee external vendors, and collaborate across DMPK, Regulatory Affairs, Biostatistics, and Clinical Operations. This role requires an advanced degree and 8–10+ years in clinical pharmacology/pharmacometrics with a proven