Senior Director, Clinical Pharmacology

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue.

We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.

The Senior Director, Clinical Pharmacology will provide strategic leadership and operational accountability for clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and model-informed drug development (MIDD) strategies across our R&D portfolio. This individual will lead modeling and simulation (M&S) activities from pre-IND through early clinical phases, late-stage global registrational trials and health authority approvals (NDA/BLA/MAA).

• Define, champion, and execute the global clinical pharmacology and quantitative M&S strategies for small molecules and biologics from pre-IND/first-in-human through Phase 2/3 and global marketing submissions
• Serve as the clinical pharmacology Subject Matter Expert (SME) on cross-functional program teams; proactively influence pipeline and clinical development strategy through quantitative logic and modeling frameworks
• Independently perform and oversee fitness-for-purpose quantitative analyses including non-compartmental analysis (NCA), population PK, PK/PD, exposure-response (E‑R), and clinical trial simulations to answer critical development questions
• Direct the design, execution, analysis, interpretation, and reporting of dedicated clinical pharmacology protocols (e.g., human ADME, drug-drug interactions [DDIs], food effect, BA/BE, and special populations such as renal or hepatic impairment)
• Author, review, and defend clinical pharmacology components of regulatory dossiers including INDs, IBs, CTAs, NDAs, BLAs, MAAs, briefing documents, and response panels; represent Keros in face‑to‑face health authority (FDA, EMA) interactions
• Cultivate deep cross-functional partnerships with internal stakeholders across DMPK, Toxicology, Biology, Translational Medicine, Biometrics, Regulatory Affairs, Clinical Operations, and CMC
• Select onboard, and manage external Contract Research Organizations (CROs) and strategic pharmacometrics vendors to ensure high-quality, time-sensitive deliverables within budgetary targets
• Lead the continuous optimization of Keros’ internal clinical pharmacology and M&S platforms by identifying, evaluating, and adopting state-of-the-art computational tools, analytical methodologies, and departmental SOPs
• Supervise, mentor, and actively develop junior scientists and quantitative modelers through both direct reporting lines and matrixed project structures

• Proven expertise in developing and implementing clinical pharmacology/M&S strategies for large molecules/biologics, with deep familiarity in managing PK/PD complexities unique to biologics (e.g., immunogenicity, antibody-drug conjugates, ligand traps, and TMDD)
• Deep hands‑on proficiency with standard industrial M&S software platforms (e.g., Phoenix Win Nonlin) is required. Secondary familiarity with SAS, Python, Julia, or MATLAB is highly valued
• Solid history of authoring regulatory submission documents (NDAs, BLAs, MAAs) accompanied by direct experience defending dosing strategies and data packages to global health authorities
• In‑depth knowledge of regulatory…