Lead, Clinical Pharmacology - Oncology Translational

ADLAI NORTYE USA INC; North Brunswick Township (NJ); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

ADLAI NORTYE USA INC. is seeking a Translational Scientist to lead clinical pharmacology efforts across early and late-stage development. The role involves PK/PD analyses, dose selection, and collaboration with cross-functional teams to advance oncology programs from IND to NDA.

The candidate will prepare regulatory documents, interact with FDA/EMA, and ensure robust study designs while managing budgets and vendor oversight in a dynamic translational research environment.

Qualifikationen

• PhD or equivalent in clinical pharmacology or related life science.
• Experience analyzing PK/PD data in early clinical trials.
• Familiar with regulatory meetings (FDA/EMA) and IND submissions.
• Experience preparing clinical pharmacology sections of protocols and reports.
• Proficient with MS Word, Excel and PowerPoint.

Aufgaben

• Provide clinical pharmacology input on dose and trial designs.
• Lead PK/PD data analyses and biomarker integration.
• Draft and review IND, IB, NDA/BLA documents and related sections.
• Collaborate across Toxicology, Bioanalytical, Clinical Development teams.
• Represent Clin Pharm on development teams and regulatory meetings.
• Oversee vendor work and ensure high-quality deliverables.
• Develop standard operating procedures for data analysis.

Kenntnisse

PK/PD data analysis

Clinical pharmacology knowledge

Regulatory interactions

Written & verbal communication

Ausbildung

PhD or equivalent in clinical pharmacology

Tools

Industry PK/PD data analysis software

Jobbeschreibung

ADLAI NORTYE USA INC. is seeking a Translational Scientist to lead clinical pharmacology efforts across early and late-stage development. The role involves PK/PD analyses, dose selection, and collaboration with cross-functional teams to advance oncology programs from IND to NDA.

The candidate will prepare regulatory documents, interact with FDA/EMA, and ensure robust study designs while managing budgets and vendor oversight in a dynamic translational research environment.