Director, Clinical Pharmacology Lead
Core
Senior Clinical Pharmacology leadership role supporting late-stage development and registration activities across a transplant-focused portfolio.
Role type
Director, Clinical Pharmacology Lead
Builds
BLAs, supplemental filings, briefing packages, and regulatory responses for transplant and immunology programs
Domain
Biopharmaceuticals, Transplant, Immunology, Nephrology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Pharmacology strategy, dose selection, benefit-risk assessment, regulatory submissions, health authority interactions, exposure-response analysis, population PK, immunogenicity assessment, Model-Informed Drug Development, mentorship
Preferred skills
Transplant, nephrology, or immunology therapeutic area experience
Technologies
Non-applicable
Responsibilities
Represent Clinical Pharmacology on program teams and governance forums; Develop and execute integrated Clinical Pharmacology strategies; Lead Clinical Pharmacology contributions to major regulatory submissions; Represent Clinical Pharmacology in health authority interactions; Drive filing-readiness activities and identify regulatory risks; Lead and oversee Clinical Pharmacology analyses including exposure-response and population PK; Provide technical mentorship and scientific leadership; Maintain current expertise in Clinical Pharmacology science and regulatory expectations
Seniority
Director, strategic leadership & mentorship
