Director, Integrated Bioanalysis - Oncology Project Lead

ASTRAZENECA UK LIMITED; Hartford; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

A global biopharmaceutical company is seeking a highly experienced candidate to develop bioanalytical strategies for their Oncology portfolio. You will interact with regulatory authorities and oversee scientific excellence in bioanalysis. Candidates should have a Ph.D. and over 10 years of relevant experience in drug development. Flexibility in working arrangements is offered alongside a competitive salary and a comprehensive benefits package.

Benefits

Employee benefits fund

Flexible time off

Pension contributions

Share Save Plans

Performance recognition

Qualifications

• Over 10 years of relevant experience in bioanalysis of small molecules and ADCs.
• Experience with regulated bioanalysis and drug development.
• Strong knowledge of global regulatory expectations.

Responsibilities

• Lead bioanalytical strategies for Oncology portfolio.
• Provide scientific oversight to bioanalytical programs.
• Interact with Regulatory Affairs for support.
• Mentor team members and guide assay development.

Skills

Bioanalytical strategy development

Scientific oversight

Regulatory interactions

Cross-functional team collaboration

Assay validation

Education

Ph.D. in biochemistry, analytical chemistry, molecular biology or immunology

Tools

CRO oversight

Bioanalytical techniques

Job description

Overview

You will be located at our research hub in Cambridge, UK, where you will work with the Oncology Development Bioanalysis Team, Therapy Area Leads and stakeholders. In this role you will interact closely with scientists in and outside the lab and you will be required to aid in experimental design and data interpretation. This is a highly visible role, and you will harness your scientific knowledge and expertise while working with a range of stakeholder and cross functional groups. You will need to use your experience of designing, developing and delivering robust bioanalytical strategies with a specific focus on scientific oversight and delivery for our Oncology portfolio. You will also work with Regulatory Affairs to interact with Health Authorities across a range of geographies to mitigate risk, submit regulatory documents and respond to Health Authority questions. As an SME, you will be responsible for enhancing the IBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts. The successful candidate will work closely with AstraZeneca laboratory groups within IBA and our vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery of our Oncology pipeline while fostering an environment of scientific knowledge exchange. You will also interact with collaborators and cross functional project teams.

Responsibilities

• Lead the development and execution of robust bioanalytical strategies for the Oncology portfolio, including endpoints such as PK, immunogenicity and biomarkers.
• Provide scientific oversight and ensure delivery of bioanalytical programs aligned with project needs; guide method development and validation in a matrixed environment.
• Interact with Regulatory Affairs to support Health Authority interactions, submit regulatory documents, and respond to questions across multiple geographies.
• Act as a Subject Matter Expert (SME) in regulated bioanalysis and drug development; present at internal and external meetings and contribute to manuscript publications.
• Collaborate with AstraZeneca laboratory groups, vendor partners and CROs to ensure appropriate bioanalytical and platform strategies; supervise assay transfer, quality, and study conduct.
• Interpret integrated and complex datasets and provide solutions to challenges while mitigating risk; lead cross-functional project teams.
• Contribute to regulatory submission documentation (e.g., INDs, CTAs, IBs, ISIs, NDAs/BLAs) and participate in regulatory authority responses across geographies.
• Mentor and coach team members; develop and maintain fit-for-purpose assay validation and context of use concepts.

Qualifications

• Ph.D. in biochemistry, analytical chemistry, molecular biology or immunology with over 10 years of relevant experience in bioanalysis of small molecules, ADCs, and next-generation modalities (e.g., PROTACs, ASOs); experience with biologics is preferred. Candidates with a B.S. or M.S. and substantial drug development, bioanalysis and regulatory interaction experience will also be considered.
• Experience of the drug development process and bioanalytical methods for small molecules, ADCs, radioconjugates including non-clinical and clinical development; familiarity with GLP and GCP compliance.
• Proven experience as an SME in regulated bioanalysis and drug development; demonstrated lead experience in diverse project teams and robust bioanalytical strategy development.
• Deep understanding of assay validation context, fit-for-purpose approaches, and CRO oversight.
• Strong knowledge of global regulatory expectations and guidance; experience with regulatory submissions and health authority interactions in Oncology is highly valued.
• Background in pharmaceutical R&D with experience in Phase II/III oncology drug development support.
• Ability to handle multiple projects concurrently in a fast-paced environment and work effectively in cross-functional teams.
• Desirable: experience with radioconjugates including scintillation counting, biodistribution, and biotransformation; expertise in a range of bioanalytical techniques (ligand binding assays, MS, flow cytometry, ELISpot, viral assays, cytokine assays, ddPCR/qPCR/RT-qPCR); understanding of DMPK, ADME and pharmacokinetic/toxicokinetic analysis.
• Ability to develop, coach and mentor team members.

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on discovery, development and commercialisation of medicines for serious diseases. We are pioneering new frontiers by identifying and treating patients earlier, with a view to eliminating cancer as a cause of death. This role is part of the Integrated Bioanalysis (IBA) Global Team, which leads and delivers bioanalytical strategies to support the Oncology portfolio across discovery, preclinical and clinical stages.

Working at AstraZeneca

We value in-person collaboration while balancing flexibility. Typical expectations include in-office presence; we support flexible working arrangements to fit individual circumstances. You will join a team that aims to accelerate portfolio development, improve patient outcomes in trials, and contribute to a digital ecosystem with patients at its core. We offer a competitive salary and benefits package, including an employee benefits fund, holiday purchase, flexible time off, pension contributions, Share Save Plans and performance recognition.