Senior Principal Scientist, Development DMPK

Role Summary

Senior Principal Scientist, Development DMPK – role focused on ADME, DDI and PK support across pipeline assets; represents Dev DMPK on cross-functional teams; oversees non-clinical metabolism and PK activities; prepares regulatory submissions and helps develop group strategy.

Responsibilities

• Represents Dev DMPK on cross-functional development project teams for small molecule therapeutics and biologics, including preparing project strategies and development plans.
• Leverage specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, or PBPK modeling to impact project progression and decision-making.
• Oversee internal and outsourced nonclinical drug metabolism and PK activities on multiple projects, including study design, data interpretation and presentation.
• Write and review nonclinical submission documents such as DMPK sections for INDs and NDAs/BLAs, Investigator Brochures, briefing books, DSUR, etc., to support clinical trials and global registrations. Interact with regulatory authorities as needed.
• Support clinical assets for all ADME, DDI and PK-related inquiries and activities.
• Assist in guiding department strategy. Supervising and/or mentoring junior scientists may be required.

Qualifications

• Required: Ph.D. or equivalent advanced degree in Life Sciences with 6+ years of academic/industry experience. Plus 2 years of leadership experience.
• Required: Bachelor's Degree with 10+ years of academic and/or industry experience; or Master's Degree with 8+ years of academic and/or industry experience.
• Preferred: PhD in pharmaceutics, biochemistry, chemistry, biology or related fields, with 8+ years of relevant drug discovery and development experience and 2+ years of leadership experience.

Skills

• Extensive expertise in drug disposition, DDI and small molecule therapeutics; understanding of techniques to characterize ADME/PK properties.
• Hands-on PBPK modeling to predict drug interactions and human PK profiles is a plus.
• Understanding of development of small molecules, biologics and new modalities including ADCs; ability to work with multidisciplinary project teams to develop ADME strategies.
• Regulatory understanding in drug metabolism, drug-drug interactions, bioanalysis, toxicology, and clinical pharmacology; experience overseeing studies internally or at CROs.
• Strong written and verbal communication skills.

Education

• Ph.D. or equivalent advanced degree in Life Sciences (preferred).
• Other degrees as listed in qualifications may apply depending on experience.