Senior Oncology Bioanalysis Strategy Lead

AstraZeneca GmbH; Cambridge (MA); On-site; USD 175,000 - 260,000; Full time

Job summary

AstraZeneca's Integrated Bioanalysis (IBA) team seeks a senior bioanalytical leader to design and implement robust strategies across PK, PD, and immunogenicity, supporting Oncology/Immuno-oncology. You will align with stakeholders, guide assay development with CROs, and drive regulatory interactions globally.

You will lead select programs, mentor scientists, and contribute to scientific leadership, publication, and strategic initiatives within the IBA group.

Qualifications

• Bachelor's or higher in immunology or molecular biology with 10+ years in Biopharma.
• Master's with 7+ years in Biopharma; experience with drug development and regulatory filings.
• Experience as SME in regulated bioanalysis across PK/PD/immunogenicity.
• Experience with CRO partnerships and delivering data to project teams.

Responsibilities

• Lead design and implementation of robust bioanalytical strategies.
• Coordinate with internal/external teams to ensure assay development and validation.
• Serve as IBA project lead on select programs.
• Engage with regulatory agencies across geographies to mitigate risk and respond to questions.
• Present at internal/external meetings and contribute to publications.

Skills

Regulated bioanalysis

Immunogenicity assessments

PK/PD analyses

Cross-functional leadership

Regulatory submissions

Project leadership

Education

Bachelor's degree in immunology or molecular biology

Master's degree in immunology or molecular biology

Tools

Ligand binding assays

LC-MS

ddPCR/qPCR/RT-qPCR

Flow cytometry

ELISpot

Viral assays

Cytokine assays

Job description

AstraZeneca's Integrated Bioanalysis (IBA) team seeks a senior bioanalytical leader to design and implement robust strategies across PK, PD, and immunogenicity, supporting Oncology/Immuno-oncology. You will align with stakeholders, guide assay development with CROs, and drive regulatory interactions globally.

You will lead select programs, mentor scientists, and contribute to scientific leadership, publication, and strategic initiatives within the IBA group.