Director, Integrated Bioanalysis – Oncology Project Lead

Director Integrated Bioanalysis – Oncology Bioanalytical Project Lead 

Location: Cambridge (3 days on-site per week)

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!

As part of the Integrated Bioanalysis (IBA) Global Team, you will lead the development and execution of bioanalytical strategies—including endpoints like PK, immunogenicity, and biomarkers to support AstraZeneca’s pipeline. You will ensure lab activities meet project needs, guide method development and validation, and interpret study data while working in a matrixed environment. Close collaboration with project teams, scientists, and partner labs is crucial. Experience with bioanalysis, Regulatory Submissions and Health Authority interactions in Oncology is highly valued. This role offers the chance to significantly impact our diverse pipeline through expert bioanalytical support.

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:

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. 

Requirements:

• Ph.D. in biochemistry, analytical chemistry, molecular biology or immunology related studies with over 10 years relevant experience in bioanalysis of small molecules, ADCs, next generation molecules such as PROTACs, ASOsor conditional molecules. Some experience with biologics is preferred. Individuals with demonstrated drug development, bioanalysis and regulatory authority interaction experience with B.S. or MS degree are also considered.

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

• Experience as an SME in regulated bioanalysis and drug development.

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

• Worked collaboratively to provide solutions to challenges and mitigate risk.

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

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

• Deep understanding of global regulatory expectations and guidance

• Background in pharmaceutical Research and Development, experienced in PhII/PhIII drug development support of Oncology drugs

• 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 complex datasets.

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

• Working in and leading cross-functional teams.

Desirables: 

• Experience with Radioconjugates including Scintillation Counting, 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 DMPK, ADME and biotransformation

• Understanding of pharmacokinetic/toxicokinetic analysis and data interpretation.

• Ability to develop, coach and mentor.

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? 

At AstraZeneca's Oncology R&D business area, you'll be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients' conditions. We're actively embracing and investing in technology, harnessing digital, data and analytics to reimagine the future of healthcare and deliver improved outcomes to patients beyond core medical. We're shaping the future, improving and speeding up portfolio development, improving the patient experience and outcomes at clinical trials. Join the team that is co-creating a digital ecosystem with patients at its core. 

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 performance recognition scheme and a competitive, generous remuneration package.