Director of Clinical Pharmacology and Quantitative Medicine

Role Summary

Director of Clinical Pharmacology and Quantitative Medicine based in USA - Pennsylvania - Upper Providence. You will lead clinical pharmacology and quantitative medicine activities that guide drug development decisions. You will work with cross-functional teams to design trials, build models, and translate data into clear dose and study recommendations. This role emphasizes scientific curiosity, teamwork, and clear communication, offering growth and visible impact on patient-focused programs as you help unite science, technology and talent to get ahead of disease.

• Lead development and application of pharmacokinetic, pharmacodynamic and mechanistic models to inform dose selection, trial design and evidence generation.
• Collaborate with clinical, translational, biomarker, regulatory and statistical teams to design efficient clinical development plans.
• Provide quantitative input for regulatory interactions and contribute to submission documents.
• Design and interpret clinical pharmacology studies assessing intrinsic and extrinsic factors, drug-drug interactions, and special populations.
• Promote and implement model-informed drug development approaches, including PK, PKPD, mechanistic and systems models, and foster external scientific collaboration.
• Communicate results clearly to diverse audiences through reports, presentations and scientific publications.

• Required:
  
  Advanced degree (PhD, Pharm
  
  D or equivalent) in clinical pharmacology, pharmaceutical sciences, quantitative biology or related field.
• Required:
  
  Minimum 5 years of industry experience in clinical pharmacology and pharmacokinetics/pharmacodynamics modelling and simulation in drug development.
• Required:
  
  Hands-on experience with pharmacometrics tools and languages (for example NONMEM, Monolix, R, SAS, MATLAB or similar).
• Required:
  
  Proven experience contributing to regulatory submissions or interactions and applying relevant guidance for clinical study design.
• Required:
  
  Demonstrated ability to design and interpret clinical pharmacology studies, including evaluation of drug interactions and special populations.
• Required:
  
  Strong collaborator who can work effectively across multi-disciplinary teams and communicate complex data clearly.
• Preferred:
  Experience with mechanistic, systems pharmacology or quantitative systems models applied to preclinical and clinical questions.
• Preferred:
  Experience across multiple drug modalities (small molecules, biologics) and therapeutic areas; preferably antisense oligonucleotides and small interfering RNAs.
• Preferred:
  Track record of scientific publications or presentations in pharmacology, modelling or related fields.
• Preferred:
  Experience leading project teams or mentoring junior scientists.
• Preferred:
  Comfort working with data science or scientific machine learning approaches that support modelling and simulation.