Eisai US · 2 days ago
Director, Clinical Pharmacology - Remote Based
Eisai is a growing pharmaceutical company focused on neurology and oncology, dedicated to satisfying unmet medical needs. The Director, Clinical Pharmacology will lead clinical pharmacology plans, develop clinical protocols, and provide expertise in regulatory documents while working within a multi-disciplinary team.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Directs and Implements clinical pharmacology plans and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)
Leads the development of Clinical Protocols to meet CDP objectives
Serves as Study Director/Clinical Pharmacology Lead and drives the execution of the study from protocol concept to final report including interpretation of clinical data
Serves as Medical Monitor (where applicable) to review and monitor study data
Implements strategies to identify, monitor and resolve clinical program/trial issues
Interprets study data and develops integrated summaries of Clinical Pharmacology data as it relates to safety and efficacy
Contributes to Clinical Pharmacology expertise and content to regulatory documents (e.g. briefing books, INDs, NDAs etc.) and represent Clinical Pharmacology in discussions with Health Authorities
Reviews 3rd party work products and deliverables to approve payment of invoices and resolve discrepancies
Qualification
Required
A PhD, MD or PharmD degree with at least 5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead
A thorough understanding of global regulatory requirements on the Clinical Pharmacology and Translational Medicine aspects of drug development
A thorough understanding of standard Clinical Pharmacology computational programs
Strong inter-personal skills are required since the job requires substantial interaction within the assigned Business Group as well with other Pre-clinical, Modeling, and Translational Science Groups
Complies with all applicable laws/regulations of each country Eisai does business in
Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients or physicians
Minimal travel required: less than 10%
Preferred
Experience in oncology, pediatric development and translational medicine is preferred but not required
Benefits
Eisai Inc. Annual Incentive Plan
Eisai Inc. Long Term Incentive Plan
Company employee benefit programs
Company
Eisai US
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. It is a sub-organization of Eisai.
H1B Sponsorship
Eisai US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (21)
2023 (12)
2022 (41)
2021 (14)
2020 (22)
Funding
Current Stage
Late StageRecent News
2026-01-06
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