Associate Director Integrated Bioanalysis – Oncology Bioanalytical Project Lead

Associate Director Integrated Bioanalysis – Oncology Bioanalytical Project Lead
Location: Cambridge (3 days on-site)

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

Join AstraZeneca's Integrated Bioanalysis (IBA) Global Team as an Associate Director, where you will spearhead the development and execution of comprehensive bioanalytical strategies to support our innovative pipeline. Your role will involve leading lab-based activities, ensuring alignment with project needs, and defining the context of use for endpoints such as PK, immunogenicity, and biomarkers. Collaborate within a matrix organization to drive bioanalytical method development, validation, study design, and data interpretation. Engage closely with Project and Study Teams, as well as scientific and technical staff, to deliver impactful results across a range of therapeutic modalities in Oncology. Are you ready to make a lasting impact on our diverse pipeline?

The IBA group within Clinical Pharmacology and Safety Sciences provides broad discovery, preclinical, and clinical support including life cycle management across all therapeutic areas enabling pipeline delivery, decision making, innovation and advancement to improve the lives of patients through life-changing medicines.

Key Responsibilities:

Located at our research hub in Cambridge, UK, you'll collaborate with a Director, Oncology Development Bioanalysis, Therapy Area Leads, and various stakeholders. This role offers the chance to work closely with scientists both inside and outside the lab, aiding in experimental design and data interpretation. As a highly visible position, you'll harness your scientific expertise to develop and deliver robust bioanalytical strategies for our Oncology portfolio. You'll also engage with Regulatory Affairs to interact with Health Authorities globally, mitigating risks and responding to inquiries. As a Subject Matter Expert, you'll enhance the IBA reputation for scientific excellence by presenting at 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.

Requirements:

• Ph.D. in biochemistry, molecular biology or immunology or analytical chemistry related studies with at least 5 years experience in bioanalysis of biologics, small molecules and/or ADCs or B.Sc or M.Sc with relevant background and 10 years demonstrated ability.

• Experience of the drug development process and bioanalytical methods for small molecules, Biologics, Antibody Drug Conjugates (ADCs) and Radioisotope-Drug Conjugates(RDCs) including non-clinical and clinical development and requirements for GLP and GCP compliance.

• Experience as a Subject Matter Expert in regulated bioanalysis across a range of modalities PK, PD and immunogenicity assessments.

• Experience as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.

• In depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysis.

• Overseen assay transfer, scientific quality and study conduct at CRO partners.

• Deep understanding of global regulatory expectations and guidance.

• Background in pharmaceutical Research and Development.

• Contribute 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 complex datasets.

• Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment.

• Ability to develop, coach and mentor.

• Validated publication and presentation record.

Desirables:

• Experience with bioanalytical methods and data interpretation for RDC's including Scintillation Counting, radioactive decay correction, biodistribution and biotransformation of both radioligands and delivery vectors.

• Skilled scientist able to discern the advantages and limitations of a range of bioanalytical techniques such as ligand binding assays, mass spectrometry, flow cytometry, ELISpot, viral assays, cytokine assays, and molecular assays (ddPCR, qPCR, RT-qPCR).

• Understanding of pharmacokinetic/toxicokinetic analysis and data interpretation.

• Experience of leading or mentoring within matrix teams.

In Office Requirement:

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.

Competitive salary and benefits package on offer!

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A

Date Posted

10-Sept-2025

Closing Date

21-Sept-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.