Associate Director, DMPK

We are seeking an Associate Director to join the DMPK team, specializing in ADME and pharmaceutical drug development for small molecule and protein therapeutics. This role involves representing the Development DMPK function on cross-functional project teams, overseeing drug metabolism and pharmacokinetics (PK) activities, contributing to regulatory submissions, and shaping departmental strategy.

Key Responsibilities:

• Represent DMPK on project teams, defining ADME and PK strategies for biologics and small molecule therapeutics.
• Oversee nonclinical drug metabolism and PK studies (internal and outsourced), including study design, data interpretation, and reporting.
• Author and review regulatory documents (e.g., CTD sections for INDs, NDAs/BLAs, Investigator Brochures, briefing books).
• Address ADME and PK-related inquiries to support clinical development.
• Contribute to department strategy and, if needed, mentor junior scientists.

Qualifications:

Basic Qualifications:

• Ph.D. in Life Sciences with 6+ years of academic or industry experience, including 2+ years of leadership experience, OR
• Master's degree with 8+ years of experience, OR
• Bachelor's degree with 10+ years of experience.
• Expertise in drug disposition and PK of small molecules, including in vitro and in vivo ADME characterization.
• Strong understanding of small molecule drug development and regulatory requirements in drug metabolism, drug-drug interactions, bioanalysis, toxicology, and clinical pharmacology.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• 10+ years of experience in drug discovery and development, with 2+ years of leadership experience.
• Knowledge of PK/PD models and human PK/dose prediction.
• Experience in bioanalysis, regulatory submissions, and CRO oversight.
• Ability to work independently with cross-functional teams to implement ADME strategies and development plans.