Sr. Director Clinical Pharmacology

📋 Description

• Lead pharmacometric and clinical pharmacology strategies for global pediatric programs.
• Lead cross-functional teams; translate quantitative insights into development decisions.
• Oversee population PK, PK/PD, exposure–response, and PBPK modeling for dose/design.
• Support regulatory strategy; author key clinical pharmacology documents; engage with authorities.
• Design clinical pharmacology studies; manage study execution and CRO/vendor relations.
• Present results to internal/external stakeholders and contribute to publications.

🎯 Requirements

• Ph.D. or Pharm.D. in PK/Pharmacometrics or related field; 10+ years biotech/pharma.
• Hands-on modeling across development; regulatory submissions; pediatric experience preferred.
• Expertise in population PK, PK/PD, PBPK; apply to clinical development and regulatory strategy.
• Proficiency in NONMEM, Monolix, NLME, Simcyp, R.
• Strong understanding of FDA/EMA guidance for MIDD and regulatory expectations.
• Excellent analytical, communication, and problem-solving skills.

🎁 Benefits

• 401(k) with employer match
• Subsidized lunch and parking on in-office days
• Flexible PTO and company holidays
• 100% employer-paid medical, dental, and vision for you and dependents
• Fertility and family-forming benefits
• Expanded mental health support