Director, Clinical Pharmacology Lead

Role: Lead Clinical Pharmacology for Biogen's transplant portfolio, focusing on strategy, execution, regulatory deliverables, and lifecycle management, including BLA submissions and health authority interactions. Responsibilities: develop integrated pharmacology strategies for dose selection, benefit-risk assessment, and lifecycle support; lead preparation of regulatory submission components; provide strategic leadership in regulatory meetings; oversee analyses such as exposure-response and population PK; mentor within the Clinical Pharmacology team; ensure compliance with evolving scientific and regulatory standards. Requirements: PhD/MD/PharmD with 8+ years industry experience supporting late-stage development, regulatory submissions, and health authority interactions; proven track record leading Clinical Pharmacology strategies for major programs; expertise in dose justification, modeling, immunogenicity, and biologics regulations; experience in transplant, immunology, or nephrology therapeutic areas. HighValue: biologics, transplant, immunology, late-stage development, BLA/NDA submissions, regulatory leadership, Model-Informed Drug Development. WorkSetup: not specified.