Director, Clinical Pharmacology – DMPK

Role Overview

• Lead all aspects of execution and oversight across nonclinical and clinical programs
• Serve as the primary liaison to external CROs, ensuring scientific quality, regulatory compliance, and timely delivery of data
• Partner cross functionally with CMC, Clinical Operations, and Regulatory to support advancement of our phase 3-ready asset
• Manage all CRO relationships related to bioanalysis, including selection, contracting, technical oversight, and performance tracking
• Ensure timely and compliant sample collection, shipping, and analysis in alignment with GxP requirements
• Experience developing population PK models and integrating them into pivotal program planning
• Familiarity with regulatory expectations for Clinical Pharmacology in NDA/MAA filings, including labeling language
• Strong partnership with clinical development, ensuring study protocols incorporate appropriate PK sampling and CDISC-aligned data plans
• Lead the Clinical Pharmacology components of global regulatory interactions (FDA, EMA)
• Alignment of Clinical Pharmacology strategy with cross-functional program priorities and commercial considerations
• Effective communication to simplify complex concepts for clinical investigators, executives, and external partners
• Collaboration with Clinical Operations, Safety, Biometrics, and Regulatory.
• Guiding the company through decision-making (interim analyses, dose adjustments, safety reviews)
• Oversight of high-quality PK sample handling, assay readiness, and data processing workflows
• Building fit-for-purpose processes that scale as the company moves from Phase III to registration
• Operate independently as the sole internal Clinical Pharmacology expert
• Be proactive and resourceful, with the ability to step beyond a narrow functional box when needed
• Influence without direct authority—shape strategy through clarity, data, and presence rather than team size
• Thrive in a fast-moving environment and adjust strategy rapidly as clinical data emerge.

Requirements

• Advanced degree (PhD, PharmD, or MS with extensive industry experience) in a relevant field such as Pharmaceutical Sciences, Bioanalysis, or Pharmacokinetics
• At least 8 years of industry experience in bioanalysis, DMPK, or clinical pharmacology within biotechnology or pharmaceutical R&D
• Proven experience managing bioanalytical CROs and overseeing assay validation, sample analysis, and data delivery for clinical-stage programs
• Strong understanding of PK principles, LC-MS/MS assay validation, and regulatory guidance (FDA, EMA, ICH)
• Demonstrated ability to interpret, communicate, and integrate complex bioanalytical and pharmacokinetic data
• Experience supporting Phase 2–3 programs with exposure to clinical pharmacology components (first-in-human through registrational studies)
• Excellent organizational and vendor management skills in a dynamic, fast-paced environment
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.