Director, Integrated Bioanalysis Oncology Development

AstraZeneca•Cambridge, MA

10d•Hybrid

About The Position

This Director role sits at the heart of Integrated Bioanalysis, driving end-to-end bioanalytical strategies that shape the future of our Oncology portfolio. The position leads the design and implementation of robust approaches for PK, immunogenicity and biomarker endpoints, ensuring assays are developed, validated and applied in line with their context of use. Working closely with internal laboratories and external CRO partners, the role provides scientific oversight across multiple modalities and stages of development. Acting as IBA project lead on selected programs, this Director partners with cross-functional teams to align on strategy, manage expectations and deliver high-quality data that informs key decisions. The role offers the chance to influence a diverse pipeline, contribute to departmental strategy and help advance life-changing medicines for patients with cancer.

Requirements

Master's in immunology, molecular biology, or related studies with minimum of 10+ years relevant experience
PhD in immunology, molecular biology, or related studies with minimum of 7+ years relevant experience in Biopharmaceutical industry.
Experienced in serving as a project representative, worked with team members, experienced in drug development process and regulatory filings.
Confirmed experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK (CK), PD and immunogenicity assessments (humoral and cellular).
Experienced in regulated bioanalysis, in-depth knowledge of complex biologics and/or bioanalysis of ADCs and related modalities
Experienced as a bioanalytical lead in diverse project teams, defining, leading, and implementing robust bioanalytical strategy to advance the portfolio.
Collaborated with team members, providing solutions to challenges and mitigating risk.
Skilled scientist able to discern the advantages of a range of analytical techniques such as Ligand binding assays, LC-MS, molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays.
Experienced in assay transfer, scientific quality, and study conduct at CRO partners, data analysis and interpretation, delivery of preclinical and clinical data to project teams.
Deep understanding of global regulatory expectations and guidance in relevant areas
Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.
Interpretation of integrated and complicated datasets
Ability to prioritise multiple projects and / or tasks concurrently in a fast-paced environment, ability to prioritize and manage resources.
Background in pharmaceutical clinical trial research
Validated publication and presentation record
Outstanding verbal and written communication skills!

Nice To Haves

T cell engagers, monoclonal Abs, ADCs, other biologics and or small molecule experience is desired.
Strong scientific background in immunology, ability to support drug programs across multiple therapeutic areas, working knowledge of flow cytometry.
Experienced in partnering with operational functions within bioanalysis, clinical operations, external CROs to develop efficient processes for bioanalytical execution.

Responsibilities

Leads integrated bioanalytical strategy and delivery for selected Oncology programs.
Partners with TA leads and stakeholders across Clinical Pharmacology and Safety Sciences, Translational Medicine, Research and Clinical Development to ensure timely, fit-for-purpose bioanalytical support.
Defines and drives bioanalytical plans for complex modalities such as ADCs, radio-conjugates, T cell engagers, biologics, cell therapies and small molecules, while maintaining strong scientific oversight of internal and external laboratory execution.
Engages with CROs on assay transfer, validation and study conduct, interprets complex datasets and communicates clear conclusions to project teams.
Contributes to regulatory submissions, addresses questions and mitigates risk across geographies.
Represents IBA at internal and external forums, publishes scientific work and helps shape strategic initiatives that strengthen the group’s position as a trusted scientific partner.
Encourages collaboration across matrixed teams, promotes knowledge exchange and ensures resources are prioritized effectively across multiple concurrent projects.