Senior Director, Clinical Pharmacology & Pharmacometrics

Why Join Us?

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell‑penetrant alpha‑helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities. Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first‑in‑class therapies across both rare and common cancers.

Its lead candidate, FOG‑001, is the first direct inhibitor of the interaction between β‑catenin and the T‑cell factor (TCF) family of transcription factors, implicated in colorectal cancer, desmoid tumors, and a range of other Wnt/β‑catenin‑driven tumors. Parabilis is also advancing investigational degraders of ERG and ARON for the treatment of prostate cancer, as well as other preclinical programs.

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.

• 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.

• PhD, Pharm
  
  D, MD, or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related quantitative discipline.
• 12+ years of experience in clinical pharmacology,…