Associate Director Integrated Bioanalysis -Biopharma Bioanalytical Program Lead
ASTRAZENECA UK LIMITED, Newtown, Cambridge
Associate Director Integrated Bioanalysis -Biopharma Bioanalytical Program Lead
Salary not available. View on company website.
ASTRAZENECA UK LIMITED, Newtown, Cambridge
- Full time
- Permanent
- Onsite working
Posted 1 day ago, 11 May | Get your application in today.
Closing date: Closing date not specified
Job ref: 9eed5acb210240fabcbb5b7150cd5c7c
Location ref: Newtown, Cambridge
Full Job Description
Are you ready to lead bioanalytical strategy that accelerates safe, transformative medicines to patients worldwide? As Associate Director based in Gothenburg, Sweden, you will shape the design and implementation of end-to-end bioanalysis across diverse modalities, translating complex data into clear program decisions that guide dose selection and clinical advancement.
You will work at the heart of a collaborative, matrixed environment-partnering closely with lab-based scientists and global project teams to build robust, compliant assays and deliver decisive PK/CK, PD, immunogenicity, and target engagement insights. Can you see yourself aligning innovative assays with program milestones to increase confidence and speed through development?
You will also engage with leaders across discovery, safety, clinical pharmacology, translational science, toxicology, and regulatory, with opportunities to represent our science externally. This role is highly visible and ideal for a scientist who thrives on impact, rigor, and cross-functional influence.
Accountabilities:
Bioanalytical Strategy Leadership: Define and drive integrated bioanalytical strategies for multiple therapeutic modalities, aligning assay plans with program milestones, dose selection, and decision endpoints to strengthen portfolio progression.
Experimental Design Partnership: Collaborate with lab-based scientists to shape experimental design, controls, and assay selection that deliver reliable PK/CK, PD, immunogenicity, and target engagement readouts.
Assay Development and Tech Transfer: Oversee assay development, qualification/validation, and transfer to internal and external labs to ensure reproducibility, scalability, and compliance.
Regulatory Interface: Prepare and review regulatory documentation; interact with global Health Authorities to address questions, mitigate risks, and enable clinical progress.
Cross-Functional Influence: Lead within a matrix environment to integrate bioanalysis across safety, clinical pharmacology, toxicology, translational science, and project teams for cohesive program strategy.
Risk Management and Quality: Anticipate analytical pitfalls, set data quality standards, and implement controls consistent with regulated bioanalysis to secure decision-ready data.
External Representation: Present scientific findings internally and externally, contribute to publications, and represent AstraZeneca in scientific forums and consortia.
Portfolio Impact: Convert bioanalytical insights into dose decisions and development acceleration, improving the probability of clinical success for patients.
Essential Skills/Experience
BSc/MSc in relevant subject with extensive experience in Bioanalysis or PhD in relevant subject with strong experience in Bioanalysis required
Proven experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments (humoral and cellular)
Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio including Biomarker & Target Engagement strategy for dose decision endpoints.
Skilled scientist able to discern the advantages and pitfalls of a range of analytical techniques such as molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass Spectrometry.
Deep understanding of small & large molecule Bioanalysis
Experienced in regulated bioanalysis for multiple drug modalities.
Demonstrable experience in PD Biomarker & Target Engagement assays
Proven publication and presentation record
Exceptional verbal and written communication skills
Desirable Skills/Experience:
Experience of working in a matrix environment
Knowledge of Immunology and or metabolic diseases