Senior Scientist, Clinical Pharmacology

Role Summary

The Senior Scientist in Clinical Pharmacology will develop clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic and small molecule programs, guide project teams from early development through late-stage clinical trials and regulatory submissions. This role involves designing and executing clinical studies, analyzing pharmacokinetic (PK)/pharmacodynamic (PD) data, and collaborating with cross-functional teams to advance therapies for neurodegenerative diseases. This role is within the Quantitative and Clinical Pharmacology (QCP) team within the Development Sciences function.

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

• Required: 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.
• Required: Proficiency in quantitative PK/PD data analysis tools (e.g., Phoenix WinNonlin, population PK analysis, exposure-response analysis, and/or PBPK modeling).
• Required: Experience in developing Clinical Pharmacology and M&S strategies, with biotherapeutics experience preferred.
• Required: Strong analytical and communication skills for presenting complex PK/PD data.
• Required: Proven ability to collaborate effectively on cross-functional teams.
• Preferred: Background in neuroscience indications and/or oligonucleotide drug development.

Education

• PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related scientific discipline.