Senior Director, Clinical Pharmacology

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

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
• Strong project management skills and ability to prioritize and manage multiple projects simultaneously
• Experience in managing external vendors is required
• Prior background or deep scientific familiarity with neuromuscular or neurodegenerative disease areas is strongly preferred

Education and Experience

• 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 biotechnology industry experience specializing in clinical pharmacology, pharmacometrics, and drug development with a clear track record of increasing leadership responsibility

Potential base pay range

• $221,000 — $250,000 USD

Our Diversity, Equity & Inclusion Mission Statement

Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Recruitment & Staffing Agencies

Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.