Associate Director - Bioanalytical Strategic Lead

Do you have expertise in and a passion for Integrated Bioanalysis? Are you ready to work at the scientific forefront, where innovations and an entrepreneurial spirit are the norm? Good, then this role might be for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.



The role
As part of the Integrated Bioanalysis (iBA) Global Team, you will be responsible for leading the design and implementation of robust bioanalytical strategies, including but not limited to, endpoints such as PK/CK, immunogenicity and biomarkers when required to support the AstraZeneca pipeline. Working with a dynamic team in a matrixed environment you will need to manage stakeholder expectations, input to project strategy and delivery while being the main collaborator with experienced and highly skilled bioanalytical scientist colleagues or our partnered labs. You will have the opportunity to have an immediate and lasting impact to 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.



What you'll do
This role will be located in Gothenburg, Sweden, where you will work alongside TA leads and stakeholders. In this non-laboratory-based role and you will be highly visible and able to use scientific knowledge and expertise while working with a range of collaborators and cross functional groups. You will need to use your experience and proven track record in designing, developing and delivering robust bioanalytical strategies and scientific oversight and delivery. You will also work 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. As a Subject Matter Expert, you will be responsible for improving 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 cell and gene therapy pipeline while fostering an environment of scientific knowledge exchange. They will also interact with stakeholders and cross functional project teams.



Essential for the role:

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PhD in immunology, molecular biology or related studies with significant relevant experience with a strong track record in regulated bioanalysis in a pharmaceutical or CRO setting.
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Proven experience as a Subject matter Expert in regulated bioanalysis for PK/CK, PD and immunogenicity assessments and experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.
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Worked collaboratively with business partners, providing solutions to challenges and mitigating risk.
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Skilled in use of bioanalytical methods in drug development such as ligand binding assays, LC-MS and molecular assays and supervising assay transfer, scientific quality and study conduct at CRO partners.
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Deep understanding of global regulatory expectations and guidance with significant contributions to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs.
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Ability to balance multiple projects and / or tasks concurrently in a fast-paced environment and associated interpretation of integrated and complicated datasets.

Desirable for the role:

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Matrix or line management experience.
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Ability to develop, coach and mentor.
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Proven publication and presentation record.
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Outstanding verbal and written communication skills.

So, what's next
Are you already imagining yourself joining our team - good, because we can't wait to hear from you!



If you have any questions please get in touch with Senior director Jo Goodman - jo.goodman@astrazeneca.com to discuss further.



We encourage your application, no later than 12 July 2023.



Additional information
Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines.

Where can I find out more
Our Social Media, Follow AstraZeneca on:

LinkedIn: https://www.linkedin.com/company/1603/

Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html

Life in Gothenburg: https://www.movetogothenburg.com/