# Senior Director, Clinical Pharmacology at Keros Therapeutics

> Hybrid · United States · Director+ · Other · open. Source: https://alderhq.app/jobs/greenhouse%3Akeros%3A4751403005 (read 2026-11-11).

## Facts (observed)

- Company: [Keros Therapeutics](https://alderhq.app/companies/keros-therapeutics)
- Location text: Lexington, MA (Hybrid); Lexington, MA (Hybrid)
- Where it can be done from (inferred): Hybrid · United States (evidence: "Location: Lexington, MA (Hybrid); Lexington, MA (Hybrid)")
- Posted: 2026-11-04 (7 days ago)
- First seen by alder: 2026-11-07 · last verified: 2026-11-08
- Reposted: 0 times · edited: 0 times
- Apply on the employer's site: https://kerostx.com/current-opportunities?gh_jid=4751403005
- Skills listed (inferred): Python

## Pay and sponsorship

- Posted pay: $221k–$250k per year (from the listing's pay field)
- Market band for similar posted roles (United States, n 5879): p25 $165k, median $210k, p75 $255k

## Description (the employer's text)

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.

Job Summary:

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).

### Primary Responsibilities

- 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
### Qualifications

- 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 WinNonlin) 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 requirements related to clinical pharmacology, M&S, and drug development
- Outstanding written and verbal communication competencies, with a demonstrated knack for articulating complex quantitative data to non-modeling colleagues and executive leadership teams
- Demonstrated ability to work effectively and collaboratively on cross-functional teams

---
Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/greenhouse%3Akeros%3A4751403005 and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.
