Associate Director Integrated Bioanalysis – Oncology Bioanalytical Project Lead in Cambridge

Associate Director: Oncology Bioanalytical Lead, Integrated Bioanalysis

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 internal and external lab‑based activities, ensuring alignment with project needs, and defining the context of use for endpoints such as PK, immunogenicity, and biomarkers. You will collaborate within a matrix organization to drive bioanalytical method development, validation, study design, and data interpretation. You will 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

You will be located at our research hub in Cambridge, UK and work alongside global colleagues such as Therapy Area leads, Translational Medicine, Clinical Pharmacology & DMPK scientists, Bioanalytical Scientists and Operations groups. In this role you will interact closely with scientists in and outside the lab and will be required to aid in experimental design and data interpretation of key experiments. This is a highly visible role, and you will be required to harness your scientific knowledge and expertise while working with a range of stakeholder and cross functional groups. You will need to use your experience in designing, developing and delivering robust bioanalytical strategies with a focus on scientific oversight and delivery for our Oncology portfolio.

You will collaborate with clinical study teams, clinical pharmacology and Translational colleagues and support studies by delivering PK, Immunogenicity, and biomarker data. You will lead internal IBA teams and external CROs and enable support of preclinical and clinical studies. You will also have opportunities to collaborate with Regulatory Agencies and Health Authorities across a range of countries and geographies to mitigate risk, submit regulatory documents and respond to Health Authority questions.

You will collaborate closely with senior bioanalytical leaders in the organization and provide support in drafting such regulatory responses. As a Subject Matter Expert, you will be responsible for enhancing the IBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts. You’ll work closely with AstraZeneca laboratory groups within IBA and our vendor partners to ensure appropriate scientific oversight and delivery of our Oncology pipeline while fostering an environment of scientific knowledge exchange.

Requirements

• PhD in immunology, biochemistry, biology, or related studies with strong relevant experience in Biopharmaceutical industry.
• Proven experience as a Subject Matter Expert in regulated bioanalysis across a range of modalities (such as Immunotherapies, T Cell Engagers or Biologics) with deep understanding of Pharmacokinetics (PK), Pharmacodynamics (PD), biomarkers and immunogenicity (ADA) assessments
• Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.
• Demonstrated experience in bioanalytical assay development and validation.
• Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk.
• Skilled scientist able to discern the advantages of a range of analytical techniques such as immunoassays, flow cytometry, receptor occupancy, cytokine assays, or molecular assays.
• In depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysis
• Experience overseeing assay transfer, scientific quality and study conduct at CRO partners.
• Deep understanding of global regulatory expectations and guidance
• Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.
• Data analysis and interpretation of integrated and complicated datasets
• Experience handling multiple projects and/or tasks concurrently in a fast‑paced environment.
• Ability to influence partners and interested parties without authority.
• Ability to innovate, learn quickly and be proactive.
• Background in pharmaceutical clinical trial research
• Proven publication and presentation record

Desirables

• Matrix management experience
• Experienced in regulated bioanalysis of multiple drug modalities including small molecules desired
• Understanding of Mass Spectrometry and small molecule bioanalysis

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.

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.

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.