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Associate Director/director Integrated

hace 5 meses


Barcelona, España AstraZeneca A tiempo completo

**Associate Director / Director Integrated Bioanalysis - Cell and Gene Therapy Strategic Lead**

**Location: Either Gaithersburg, Boston, Gothenburg, Barcelona**

**Bold Game-changers. Push the boundaries of science. Confidently break new ground. **Are you ready to work at a ground breaking organization where scientific innovations and an entrepreneurial spirit are the norm? We’re looking for dynamic leaders with vision with curious minds, who are comfortable taking inquisitive risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences.

**The role**

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.

**What you’ll do**

**Education/Experience required**:

- PhD in immunology, molecular biology or related studies with significant validated experience

**Crucial for the role**:

- Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio
- Worked collaboratively with collaborators, providing solutions to challenges and mitigating risk
- Skilled in use of bioanalytical methods in drug development such as molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays etc.
- Been responsible for assay transfer, scientific quality and study conduct at CRO partners
- Deep understanding of global regulatory expectations and mentorship
- 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 complicated datasets
- Ability to prioritize multiple projects and / or tasks concurrently in a fast-paced environment
- Ability to develop, coach and mentor
- Background in pharmaceutical clinical trial research
- Validated publication and presentation record
- Exceptional verbal and written communication skills

**Desirable for the role**:

- Matrix or line management experience
- Experienced in regulated bioanalysis for other drug modalities

So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you