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
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Potential base pay range
$221,000-$250,000 USD
