Senior Director, Clinical Pharmacology

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