Sr. ADME and Quantitative Pharmacology Director

In this role, you will provide strategic and technical leadership across DMPK and quantitative pharmacology functions, ensuring strong integration across discovery, development, and regulatory activities. You will guide modeling, PK/PD strategy, and clinical pharmacology approaches to support decision-making and optimize development programs.

• Lead DMPK and PK/PD strategy across discovery and clinical development programs, from candidate selection through regulatory submission.
• Drive clinical pharmacology activities including dose optimization, exposure–response modeling, and risk–benefit assessment for early- and late-stage assets.
• Oversee study design, execution, and interpretation of PK/PD and ADME studies in collaboration with cross-functional teams.
• Provide scientific input for regulatory submissions (IND, NDA, BLA) and support interactions with global health authorities.
• Serve as subject matter expert in clinical pharmacology and DMPK during FDA, EMA, and other regulatory engagements.
• Partner with discovery and translational teams to integrate ADME and PK/PD data into pipeline progression decisions.
• Align quantitative pharmacology strategy with clinical, regulatory, and manufacturing objectives across multiple programs.

Requirements

This role requires extensive experience in clinical pharmacology, DMPK, and quantitative modeling within biotech or pharmaceutical environments, along with proven leadership in cross-functional drug development.

• PhD, PharmD, MD, or equivalent advanced degree in pharmacokinetics, clinical pharmacology, pharmaceutical sciences, or related field.
• 15+ years of experience in DMPK, clinical pharmacology, and quantitative pharmacology within biotech or pharma.
• Strong expertise in PK/PD modeling, exposure–response analysis, dose finding, and modeling & simulation approaches.
• Deep understanding of regulatory frameworks (FDA, EMA, ICH) for small molecule drug development.
• Demonstrated experience supporting IND, NDA, or BLA submissions and leading regulatory interactions.
• Proven ability to collaborate with CROs, academic partners, and cross-functional internal teams.
• Strong leadership skills with experience guiding teams and influencing at all organizational levels.
• Excellent communication skills with the ability to translate complex quantitative insights into actionable development strategies.

Benefits

• Competitive senior executive-level compensation (base salary range: $340,000–$390,000)
• Comprehensive medical, dental, and vision coverage (90% employer-covered)
• 401(k) retirement plan with company match
• Flexible paid time off policy
• Adoption assistance program
• Opportunity to contribute to high-impact drug discovery programs in a fast-growing biotech environment
• Collaborative, mission-driven culture focused on scientific innovation and patient impact