Senior Scientist, Clinical Pharmacology

Role Summary

Senior Scientist, Clinical Pharmacology. Develop clinical pharmacology and modeling and simulation strategies for biotherapeutic and small molecule programs, guide project teams from early development through late-stage clinical trials and regulatory submissions, and analyze PK/PD data to support clinical decision-making within the Quantitative and Clinical Pharmacology team.

Responsibilities

• Develop Clinical Pharmacology and M&S strategies for multiple biotherapeutics and small molecule programs from pre-IND through late-stage clinical studies, including pivotal Phase 2/3 trials and NDA/MAA/BLA submissions.
• Develop clinical study designs and write study protocols, amendments, and reports that meet regulatory standards and project timelines with minimal supervision.
• Conduct hands-on pharmacokinetic (PK) and pharmacodynamic (PD) data analysis using advanced tools and methodologies to support clinical decision-making.
• Analyze, interpret, and communicate PK/PD data to project teams, senior leadership, and regulatory authorities.
• Author and review sections of regulatory submissions, including IND/CTA and NDA/MAA/BLA filings.

Qualifications

• PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related scientific discipline with 5+ years experience in Clinical Pharmacology and drug development; may include relevant postdoctoral experience.
• Proficiency in quantitative PK/PD data analysis tools (e.g., Phoenix WinNonlin, population PK analysis, exposure-response analysis, and/or PBPK modeling).
• Experience in developing Clinical Pharmacology and M&S strategies, with biotherapeutics experience preferred.
• Strong analytical and communication skills for presenting complex PK/PD data.
• Proven ability to collaborate effectively on cross-functional teams.
• Background in neuroscience indications and/or oligonucleotide drug development preferred.

Skills

• Clinical pharmacology and pharmacokinetic/pharmacodynamic analysis
• Modeling and simulation (M&S)
• Regulatory submission preparation
• Cross-functional collaboration
• Data interpretation and communication

Education

• PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related field