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Senior Director Integrated Bioanalysis -Oncology Bioanalytical Strategy Lead
Introduction To 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. You will be intimately involved in selected oncology program support by engaging with project teams/sub-teams, developing holistic bioanalytical strategies, work closely with lab-based internal and external (CRO) teams to ensure development and validation of assays aligned with context of use. You may directly manager and/or serve as a matrix manger to manage aspects such as experimental design and tech transfer and will need to foster close interaction with other scientific and technical staff in the lab as well as with cross-functional stake holders. The ideal candidate will have a strong history in regulated bioanalysis supporting therapeutic modalities across Oncology/Immuno-oncology. Experience in supporting cell and gene therapy projects in addition to traditional biologics and background in immunology/immunogenicity areas is a plus. Collaborating 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 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 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) where you will work alongside TA leads and stakeholders in CPSS, Translational Medicine, Research and Clinical development. In this role you will interact closely with scientists in and outside the lab 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 portfolio. 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 enhancing the IBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts. As a senior leader in the iBA-global oncology strategy team you will be expected to contribute to strategic initiatives aimed at continued evolution and establishment of the department as a scientific leader/strategic partner.
The successful candidate will work closely with AstraZeneca groups within IBA and our vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery of our biologics, cell and gene therapy pipeline while fostering an environment of scientific knowledge exchange. They will also interact with stakeholders and cross functional project teams.
Education/Experience Required
PhD in immunology, molecular biology, or related studies. >15 years of relevant industry experience in bioanalysis and drug development. Experienced cross-functional team leader
Essential 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.
Collaborated with stakeholders, providing solutions to challenges and mitigating risk.
Skilled scientist able to discern the advantages of aa 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
In depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysis
Overseen 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 datasets
Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment.
Ability to develop, coach and mentor people.
Background in pharmaceutical clinical trial research
Proven publication and presentation record
Exceptional verbal and written communication skills
Desirable For The Role
Both Line and Matrix management experience
Experienced in regulated bioanalysis of cell and gene therapy and other advanced drug modalities.
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.
At AstraZeneca's Biopharmaceuticals R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Embrace new and varied opportunities to develop and learn at AstraZeneca. Here, you get to work on things that have never been done before. In return, when great science comes alive, we have the opportunity to get published.
Are you ready to make a difference? Apply now and join us in our mission to improve the lives of patients through life-changing medicines!
Salary : Negotiable
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