Senior Director, Clinical Pharmacology

Keros Therapeutics•Lexington, MA

9h•$221,000 - $250,000

About The Position

The Senior Director, Clinical Pharmacology provides strategic leadership and operational accountability for clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and model-informed drug development (MIDD) across Keros’ R&D portfolio. The role leads modeling and simulation activities from pre-IND through early clinical development, late-stage global registrational trials, and health authority approvals, including NDA, BLA, and MAA submissions. This position establishes and executes clinical pharmacology and quantitative modeling strategies for small molecules and biologics, provides subject matter expertise on cross-functional program teams, oversees quantitative analyses and dedicated clinical pharmacology studies, and authors and defends regulatory materials. It also manages external research and pharmacometrics vendors, advances internal platforms and methods, and mentors junior scientists and modelers. The role requires an advanced degree in a relevant scientific discipline and 8 to 10+ years of pharmaceutical or biotechnology industry experience in clinical pharmacology, pharmacometrics, and drug development. The potential base pay range is $221,000–$250,000 USD. Keros describes itself as an inclusive and equal opportunity employer.

Requirements

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 increasing leadership responsibility.
Proven expertise developing and implementing clinical pharmacology and modeling and simulation strategies for large molecules and biologics, including familiarity with biologics-related PK/PD complexities such as immunogenicity, antibody-drug conjugates, ligand traps, and target-mediated drug disposition (TMDD).
Hands-on proficiency with standard industry modeling and simulation software, such as Phoenix WinNonlin.
Experience authoring regulatory submission documents, including NDAs, BLAs, and MAAs, and directly defending dosing strategies and data packages to global health authorities.
In-depth knowledge of regulatory requirements related to clinical pharmacology, modeling and simulation, and drug development.
Excellent written and verbal communication skills, including the ability to explain complex quantitative data to non-modelers and executive leaders.
Ability to work effectively and collaboratively on cross-functional teams.
Strong project management skills and ability to prioritize and manage multiple projects simultaneously.
Experience managing external vendors.

Nice To Haves

Familiarity with SAS, Python, Julia, or MATLAB.
Background or deep scientific familiarity with neuromuscular or neurodegenerative disease areas.

Responsibilities

Define, champion, and execute global clinical pharmacology and quantitative modeling and simulation 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 on cross-functional program teams and influence pipeline and clinical development strategy using quantitative reasoning and modeling frameworks.
Perform and oversee quantitative analyses, including non-compartmental analysis, population PK, PK/PD, exposure-response analyses, and clinical trial simulations.
Direct the design, execution, analysis, interpretation, and reporting of dedicated clinical pharmacology protocols, including human ADME, drug-drug interactions, food effect, BA/BE, and studies in special populations such as renal or hepatic impairment.
Author, review, and defend clinical pharmacology components of regulatory dossiers and represent Keros in health authority interactions with agencies such as the FDA and EMA.
Build cross-functional partnerships across DMPK, Toxicology, Biology, Translational Medicine, Biometrics, Regulatory Affairs, Clinical Operations, and CMC.
Select, onboard, and manage external CROs and strategic pharmacometrics vendors to deliver quality work on schedule and within budget targets.
Optimize internal clinical pharmacology and modeling and simulation platforms by identifying and adopting computational tools, analytical methodologies, and departmental SOPs.
Supervise, mentor, and develop junior scientists and quantitative modelers through direct reporting and matrixed project structures.
Prioritize and manage multiple projects while collaborating effectively across teams.