Director, Oncology Bioanalysis Strategy

AstraZeneca; Cambridge (MA); On-site; USD 175,000 - 263,000; Full time

Job summary

AstraZeneca is seeking a senior bioanalytical leader to design and implement robust strategies supporting oncology programs. You will lead IBA initiatives, coordinate with CPSS and Translational Medicine, and interact with CROs for assay development and regulatory readiness.

You will collaborate across global teams, contribute to regulatory submissions, and help establish IBA as a scientific leader. The role is based in the US with potential hub locations in Gaithersburg or Boston.

Qualifications

• Proven experience as a Subject matter Expert in regulated bioanalysis across PK, PD and immunogenicity assessments.
• Experience in regulated bioanalysis of complex biologics and ADCs.
• Experience as a bioanalytical lead in diverse project teams and CRO collaboration.

Responsibilities

• Design, develop, and oversee bioanalytical strategies for oncology programs.
• Lead cross-functional teams and communicate strategy to stakeholders and regulatory bodies.
• Oversee assay transfer, data analysis, and regulatory submission support across geographies.

Skills

Bioanalytical leadership

Regulated bioanalysis

PK/PD/Immunogenicity

Analytical techniques

Assay transfer

Data interpretation

Education

Bachelor's degree in immunology or related

Master's degree in immunology or related

Tools

LC-MS

qPCR/RT-qPCR

Flow cytometry

ELISpot

Viral assays

Job description

AstraZeneca is seeking a senior bioanalytical leader to design and implement robust strategies supporting oncology programs. You will lead IBA initiatives, coordinate with CPSS and Translational Medicine, and interact with CROs for assay development and regulatory readiness.

You will collaborate across global teams, contribute to regulatory submissions, and help establish IBA as a scientific leader. The role is based in the US with potential hub locations in Gaithersburg or Boston.