Director, Clinical Pharmacology

Allucent

1d•Hybrid

About The Position

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Director, Clinical Pharmacology to join our A-team (office-based/remote). As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading Clinical Pharmacology activities within the Clinical Pharmacology, Modeling, and Simulation unit of Allucent.

Requirements

PharmD or Ph.D. in a relevant area
8+ years of relevant work experience
Strong written and verbal communication skills including good command of English language
Client focused
Ability to work in a fast-paced environment

Responsibilities

Take independent leadership in providing strategic clinical pharmacology advice to clients within a cross-functional team, covering overall drug development activities.
Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies (including renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and offer recommendations to enhance pharmacokinetic sampling and dosing strategies.
Thoroughly assess the technical and scientific components of PK and PK/PD projects and programs for clients, with knowledge of noncompartmental analysis as well as population PK, PBPK, and QSP modeling.
Oversee the development of statistical and PK analysis plans, standalone PK/PD reports, and PK/PD sections of clinical study reports, and take the lead in reviewing clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packages, and other clinical and regulatory documents.