Director, Integrated Bioanalysis Oncology Development

AstraZeneca; Cambridge (MA); On-site; USD 175,498 - 263,247; Full time

Benefits offered by this job

Health, dental and vision coverage

Retirement programs

Paid time off

Job summary

AstraZeneca is seeking a Director in Integrated Bioanalysis to design and implement bioanalytical strategies for its Oncology portfolio. This role requires managing bioanalytical plans for complex modalities, engaging with CROs, and ensuring compliance with regulatory standards.

The ideal candidate should possess a Master's or PhD in relevant fields, extensive experience in biopharmaceutical bioanalysis, and strong communication skills. The position includes attractive benefits and is based in Cambridge, Massachusetts.

Qualifications

• Strong background in immunology; ability to support drug programs across therapeutic areas.
• 10+ years experience in biopharmaceutical industry or 7+ years with a PhD.
• Validation and presentation record.

Responsibilities

• Define and drive bioanalytical plans for complex modalities.
• Engage with CROs on assay transfer and study conduct.
• Provide scientific oversight across multiple modalities.

Skills

Master’s in immunology, molecular biology, or related studies

10+ years relevant experience

Subject Matter Expert in regulated bioanalysis

Experience with regulated bioanalysis

Skilled in analytical techniques (ligand-binding, LC-MS)

Outstanding verbal and written communication

Education

PhD in immunology, molecular biology, or related studies

Tools

Flow cytometry

ddPCR

LC-MS

Job description

Overview

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.

Key Responsibilities

• Define and drive bioanalytical plans for complex modalities such as ADCs, radio‑conjugates, T cell engagers, biologics, cell therapies and small molecules.
• Maintain strong scientific oversight of internal and external laboratory execution.
• Engage with CROs on assay transfer, validation and study conduct.
• Interpret complex datasets and communicate clear conclusions to project teams.
• Interact with global Health Authorities, contributing to regulatory submissions and addressing questions to mitigate risk across geographies.
• Represent IBA at internal and external forums, publish scientific work and shape strategic initiatives that strengthen the group’s position as a trusted scientific partner.
• Encourage collaboration across matrixed teams, promote knowledge exchange and prioritize resources effectively across multiple concurrent projects.

Essential Skills & Experience

• Master’s in immunology, molecular biology, or related studies with minimum 10+ years relevant experience.
• PhD in immunology, molecular biology, or related studies with minimum 7+ years relevant experience in the biopharmaceutical industry.
• Confirmed experience as a Subject Matter Expert in regulated bioanalysis across a range of modalities PK (CK), PD and immunogenicity assessments (humoral and cellular).
• Experience with regulated bioanalysis and in‑depth knowledge of complex biologics and/or bioanalysis of ADCs and related modalities.
• Led bioanalytical strategy in diverse project teams, defining, leading, and implementing robust approaches to advance the portfolio.
• Provided solutions to challenges and mitigated risk in collaboration with team members.
• Skilled in a range of analytical techniques such as ligand‑binding assays, LC‑MS, molecular assays (ddPCR, qPCR, RT‑qPCR), flow cytometry, ELISpot, viral assays and 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 prioritize multiple projects and/or tasks concurrently in a fast‑paced environment.
• Background in pharmaceutical clinical trial research.
• Validated publication and presentation record.
• Outstanding verbal and written communication skills.

Desirable Skills & Experience

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

Benefits and Compensation

The annual base pay ranges from $175,498.40 to $263,247.60. Eligibility for short‑term incentive bonuses, equity‑based awards and commissions for sales roles is available. Health, dental and vision coverage, qualified retirement programs, paid time off (vacation, holidays and leaves) are also offered.

Equal Opportunity Employer

AstraZeneca offers an environment where science leads the way. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Posting Dates

Date Posted: 06‑May‑2026

Closing Date: 30‑Aug‑2026