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Parabilis Medicines · 1 day ago

Senior Director, Clinical Pharmacology & Pharmacometrics

Cambridge, MA

Full-time

Onsite

Director/Executive

$250K/yr - $300K/yr

12+ years exp

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets. The Senior Director of Clinical Pharmacology & Pharmacometrics provides scientific, functional, and operational leadership across assigned drug development programs, focusing on designing and executing clinical pharmacology strategies and collaborating with cross-functional teams.

Biotechnology

H1B Sponsor Likely

Responsibilities

Lead the design and implementation of clinical pharmacology and pharmacometrics strategies for assigned programs, from early development through registration and lifecycle management

Integrate PK/PD modeling, exposure–response, and quantitative pharmacology to support data-driven decision-making and model-informed drug development (MIDD)

Collaborate with the VP, Head of Clinical Pharmacology, to ensure alignment with the overall departmental and organizational strategy

Serve as the global CPP lead on cross-functional project teams, providing scientific guidance on study design, dose rationale, and risk–benefit assessment

Partner with Translational Medicine, Biomarker Sciences, and Biostatistics to incorporate quantitative and mechanistic insights into clinical development plans

Oversee planning, conduct, and interpretation of clinical pharmacology studies (e.g., FIH, DDI, food effect, special population studies)

Ensure timely and high-quality preparation of study protocols, analysis plans, and reports

Author and review clinical pharmacology sections of regulatory submissions (IND, CTA, NDA, BLA) and represent the function in interactions with global health authorities (FDA, EMA, PMDA, NMPA)

Support cross-functional integration of modeling and simulation into global regulatory strategies and provide scientific input to agency queries

Apply and oversee population PK/PD, PBPK, exposure–response, and disease modeling approaches to support dose selection, trial design, and risk management

Promote the use of innovative modeling techniques, including AI/ML, Bayesian methods, and quantitative systems pharmacology

Drive implementation of new tools and processes that enhance the impact and efficiency of model-informed development

Provide scientific and functional leadership to clinical pharmacology and pharmacometrics team members working on assigned programs

Mentor and develop staff to foster scientific excellence, collaboration, and continuous learning

Contribute to departmental initiatives, best practice development, and knowledge sharing in partnership with the VP and other senior leaders

Represent Clinical Pharmacology in cross-functional governance discussions and external scientific forums

Qualification

Clinical PharmacologyPharmacometricsModeling & SimulationRegulatory KnowledgeData Analysis ToolsLeadershipAI ToolsCommunication SkillsCollaboration SkillsPresentation SkillsMentorship

Required

PhD, PharmD, MD, or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related quantitative discipline

12+ years of experience in clinical pharmacology, pharmacometrics, or quantitative drug development in the biopharmaceutical industry

Demonstrated success in designing and leading clinical pharmacology strategies at the program or portfolio level

Strong understanding of regulatory expectations (FDA, EMA, PMDA, NMPA) for clinical pharmacology and modeling & simulation

Proficiency in modeling and data analysis tools (e.g., NONMEM, Monolix, Phoenix NLME, MATLAB, R)

Proven ability to lead in matrixed environments, influence cross-functional teams, and drive decision-making

Excellent communication, collaboration, and presentation skills

Demonstrated use of AI tools in your current role and responsibilities is required

Preferred

Experience with both small molecules and biologics; exposure to novel modalities (e.g., gene or cell therapies) preferred

Advanced or innovated use of AI is a strong plus

Benefits

Annual target bonus

Equity

Comprehensive suite of competitive benefits designed to support our employees' overall well-being

Company

Parabilis Medicines

Parabilis Medicines™ is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer.

Founded in 2016

Cambridge, MA, US

51-200 employees

https://parabilismed.com/

H1B Sponsorship

Parabilis Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (4)

2023 (1)

2022 (2)

2020 (2)