Sr. Principal Scientist, Clinical Pharmacology
Core
Leads Clinical Pharmacology scientific support for clinical development programs, including planning, execution, and interpretation of PK/PD and exposure-response activities.
Role type
Sr. Principal Scientist, Clinical Pharmacology
Builds
Clinical development programs for neurological, psychiatric, endocrine, and immunological disorders
Domain
Biopharmaceuticals / Clinical Pharmacology
Required skills
Pharmacokinetic and pharmacodynamic data interpretation, Clinical trial design and dose selection, Regulatory document preparation (INDs, CTAs, NDAs, MAAs), In silico modeling and simulation, CRO management, Cross-functional team leadership
Preferred skills
Strategic planning, Mentoring junior scientists, Regulatory guidance knowledge
Technologies
In silico modeling and simulation tools
Responsibilities
Lead planning and execution of PK/PD and exposure-response activities; Serve as Clinical Pharmacology representative on cross-functional teams; Oversee Clinical Pharmacology deliverables for regulatory submissions; Manage external vendors and CROs; Mentor junior scientists
Seniority
Principal, hands-on IC with strategic input