Associate Director, Clinical Pharmacology/Senior Clinical Pharmacologist
Core
Conceive, execute, and manage multi-disciplinary Clinical Pharmacology development plans and strategies to achieve commercial goals and regulatory requirements; generate and lead PK/PD study proposals.
Role type
Senior IC clinical pharmacologist (strategy & project lead)
Builds
Clinical pharmacology and biopharmaceutics strategies for Phase 1-4 studies
Domain
Biopharmaceuticals / Clinical Pharmacology / Pharmacometrics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PK/PD study design, regulatory document authoring, data analysis and interpretation, MoA and disease specifics explanation, cross-functional team leadership, scientific publication authoring, due diligence assessments, regulatory meeting representation
Preferred skills
PBPK modeling, systems pharmacology, drug metabolism/transporters expertise, KOL interaction, business development due diligence
Technologies
CTDs, investigator brochures, population PK reports, exposure-response analyses
Responsibilities
Design Phase 1-4 studies and clinical pharmacology strategy; lead teams and perform data analyses; author regulatory documents and scientific publications; represent Clinical Pharmacology at strategy teams and regulatory meetings; drive unified positions across clinical, CMC, and regulatory teams.
Seniority
Senior, hands-on IC with strategic oversight