Director, Clinical Pharmacology (Immunology)

AbbVie

Director-level clinical pharmacology role leading PK/PD strategy, regulatory submissions, and cross-functional projects in immunology drug development. Requires advanced degree with substantial pharma experience and demonstrated leadership in pharmacometrics and bioanalytical sciences.

Responsibilities

Lead clinical pharmacology and PK/PD activities on multiple major projects with regulatory and strategic focus
Conduct risk assessments, issue resolution, and contingency planning to maintain alignment with drug development objectives
Prepare clinical protocols, scientific reports, and regulatory submissions; anticipate and respond to agency comments
Perform business development due diligence and represent clinical pharmacology on cross-functional teams
Mentor team members and drive process improvement initiatives within the department

Requirements

PhD with 7+ years relevant experience, or PharmD with 9+ years, or MS with 15+ years, or BS with 17+ years
Expertise in PK, PBPK, PK-PD, pharmacometrics, drug metabolism, or systems pharmacology
Proven leadership competencies across multiple development phases and therapeutic areas
Project management skills including scope, progress tracking, and timeline management
Knowledge of pharma drug development processes and regulatory submission strategies
Strong interpersonal and cross-functional communication abilities
Experience with pharmacometric modeling, biopharmaceutics, and data analysis methods

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Vacancy posted 6 days ago

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