Director, Oncology Bioanalytical Strategy Lead, Integrated Bioanalysis
Director Integrated Bioanalysis -Oncology Bioanalytical Strategy Lead Bold DisruptorsPush the boundaries of scienceFearlessly break new ground.Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We are looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences.What we doWe are a global, science-led Biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.Why we love it.The future is bright at AstraZeneca as we bring ground-breaking therapies to complex disease to patients with critical needsScientific innovations are at the core of what we do across our industry leading portfolio which drive exciting opportunities and varied workWe are on an exciting journey to pioneer the future of healthcare!The roleAs 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 You will be intimately involved in ensuring lab-based activities are aligned with context of use. You will work in a matrix manger with to manage aspects such as experimental design and tech transfer and will need to foster s close interaction with other scientific and technical staff in the lab. The ideal candidate will have a strong track record in regulated bioanalysis supporting therapeutic modalities across Oncology. 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 interface with experienced and highly skilled bioanalytical scientist colleagues or our partnered labsYou 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 will do You will be located at one of our research hubs ideally on the east coast of the US, (Gaithersburg, MD or Boston , MA) or Cambridge, UK, where you will work alongside TA leads and stakeholdersIn this role you will interact closely with scientist in and outside the lab based and you 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 leverage your scientific knowledge and expertise while working with a range of stakeholder and cross functional groups You will need to use your experience and proven track record designing, developing and delivering robust bioanalytical strategies with a specific focus on scientific oversight and delivery for our Oncology portfolioYou 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 questionsAs 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.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 exchangeThey will also interact with stakeholders and cross functional project teams.Education/Experience required:
PhD in immunology, molecular biology or related studies with significant relevant experienceEssential for the role:
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.Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk.Skilled scientist able to discern the advantages and fir fall 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 SpectrometryIn depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysisOverseen 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.Interpretation of integrated and complicated datasetsAbility to handle multiple projects and / or tasks concurrently in a fast-paced environment.Ability to develop, coach and mentor.Background in pharmaceutical clinical trial researchProven publication and presentation recordExceptional verbal and written communication skillsDesirable for the role:
Matrix or line management experienceExperienced in regulated bioanalysis for other drug modalitiesDate Posted19-Apr-2024Closing Date30-Apr-2024Our mission is to build an inclusive and equitable environmentWe want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment processWe welcome and consider applications from all qualified candidates, regardless of characteristicsWe offer reasonable adjustments/accommodations to help all candidates to perform at their bestIf you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation:
US - Waltham - MA; US - Gaithersburg - MD; UK - CambridgeType:
Full time Recommended Skills Assessments Clinical Trials Clinical Works Coaching And Mentoring Curiosity Decision Making Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
PhD in immunology, molecular biology or related studies with significant relevant experienceEssential for the role:
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.Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk.Skilled scientist able to discern the advantages and fir fall 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 SpectrometryIn depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysisOverseen 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.Interpretation of integrated and complicated datasetsAbility to handle multiple projects and / or tasks concurrently in a fast-paced environment.Ability to develop, coach and mentor.Background in pharmaceutical clinical trial researchProven publication and presentation recordExceptional verbal and written communication skillsDesirable for the role:
Matrix or line management experienceExperienced in regulated bioanalysis for other drug modalitiesDate Posted19-Apr-2024Closing Date30-Apr-2024Our mission is to build an inclusive and equitable environmentWe want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment processWe welcome and consider applications from all qualified candidates, regardless of characteristicsWe offer reasonable adjustments/accommodations to help all candidates to perform at their bestIf you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation:
US - Waltham - MA; US - Gaithersburg - MD; UK - CambridgeType:
Full time Recommended Skills Assessments Clinical Trials Clinical Works Coaching And Mentoring Curiosity Decision Making Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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