Associate Director, Clinical Pharmacology (Immunology)
Core
Conceive, execute, and manage multi-disciplinary Clinical Pharmacology development plans and strategies to achieve commercial goals and regulatory requirements for immunology products.
Role type
Senior IC Clinical Pharmacology Director (Immunology)
Builds
Clinical pharmacology strategies, PK/PD study proposals, regulatory documents, and scientific publications for immunology assets.
Domain
Biopharmaceuticals / Immunology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology strategy, PK/PD study design, pharmacometrics, regulatory document authoring, cross-functional leadership, scientific publication, KOL interaction, business development due diligence
Preferred skills
Systems pharmacology, drug metabolism/transporters expertise, strategic thinking, enterprise view
Technologies
PK/PD modeling tools, PBPK software, CTD formatting
Responsibilities
Design Phase 1-4 studies and clinical pharmacology strategy; lead teams in data analysis and interpretation of model results; author regulatory documents including protocols, study reports, and label sections; lead clinical pharmacology meetings and represent the function at cross-functional teams; drive unified clinical pharmacology positions to clinical, CMC, and regulatory teams; conduct due diligence assessments for business development; represent Clinical Pharmacology at regulatory meetings.
Seniority
Director, strategic leadership & hands-on execution