Role Description
The Senior Director of Clinical Pharmacology & Pharmacometrics (CPP) provides scientific, functional, and operational leadership across assigned drug development programs. Reporting to the VP, Head of Clinical Pharmacology, this individual is responsible for designing and executing program-level clinical pharmacology and pharmacometric strategies, ensuring their integration into global development plans. The Senior Director works cross-functionally with Clinical Development, DMPK, Regulatory, and Biostatistics to optimize dose selection, study design, and quantitative decision-making from early to late development.
Key Responsibilities
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Lead the design and implementation of clinical pharmacology and pharmacometrics strategies for assigned programs, from early development through registration and lifecycle management.
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Integrate PK/PD modeling, exposure–response, and quantitative pharmacology to support data-driven decision-making and model-informed drug development (MIDD).
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Collaborate with the VP, Head of Clinical Pharmacology, to ensure alignment with the overall departmental and organizational strategy.
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Serve as the global CPP lead on cross-functional project teams, providing scientific guidance on study design, dose rationale, and risk–benefit assessment.
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Partner with Translational Medicine, Biomarker Sciences, and Biostatistics to incorporate quantitative and mechanistic insights into clinical development plans.
Operational Excellence
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Oversee planning, conduct, and interpretation of clinical pharmacology studies (e.g., FIH, DDI, food effect, special population studies).
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Ensure timely and high-quality preparation of study protocols, analysis plans, and reports.
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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).
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Support cross-functional integration of modeling and simulation into global regulatory strategies and provide scientific input to agency queries.
Modeling, Simulation & Innovation
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Apply and oversee population PK/PD, PBPK, exposure–response, and disease modeling approaches to support dose selection, trial design, and risk management.
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Promote the use of innovative modeling techniques, including AI/ML, Bayesian methods, and quantitative systems pharmacology.
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Drive implementation of new tools and processes that enhance the impact and efficiency of model-informed development.
Leadership & Mentorship
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Provide scientific and functional leadership to clinical pharmacology and pharmacometrics team members working on assigned programs.
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Mentor and develop staff to foster scientific excellence, collaboration, and continuous learning.
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Contribute to departmental initiatives, best practice development, and knowledge sharing in partnership with the VP and other senior leaders.
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Represent Clinical Pharmacology in cross-functional governance discussions and external scientific forums.
Qualifications
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PhD, PharmD, MD, or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related quantitative discipline.
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12+ years of experience in clinical pharmacology, pharmacometrics, or quantitative drug development in the biopharmaceutical industry.
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Demonstrated success in designing and leading clinical pharmacology strategies at the program or portfolio level.
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Strong understanding of regulatory expectations (FDA, EMA, PMDA, NMPA) for clinical pharmacology and modeling & simulation.
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Proficiency in modeling and data analysis tools (e.g., NONMEM, Monolix, Phoenix NLME, MATLAB, R).
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Proven ability to lead in matrixed environments, influence cross-functional teams, and drive decision-making.
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Experience with both small molecules and biologics; exposure to novel modalities (e.g., gene or cell therapies) preferred.
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Excellent communication, collaboration, and presentation skills.
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Demonstrated use of AI tools in your current role and responsibilities is required. Advanced or innovated use of AI is a strong plus.
Benefits
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The base salary target for this position is $265,000-$320,000 per year, depending on experience, qualifications, and internal practices.
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Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.
Core Values
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Growth-Minded: We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
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In(ter)dependent: We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
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Patient-focused: We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
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All-In: We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.