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, immunogenicity and biomarkers to support the AstraZeneca pipeline.
\nYou will be intimately involved in selected oncology portfolio support by engaging with key stake holder functions in 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.
\nYou will serve as the IBA project lead on the select programs, ensure development of sound bioanalytical assay designs and implementation by working closely with iBA scientific and technical staff in the lab as well as with cross-functional stake holders.
\nThe ideal candidate will have a strong history in regulated bioanalysis supporting therapeutic modalities across Oncology/Immuno-oncology. Experience in supporting Antibody-drug or Radio-Conjugates or TCEs, in addition to traditional biologics and background in immunology/immunogenicity is desired.
\nCollaborating 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 the highly skilled bioanalytical scientist colleagues within iBA and/or our partnered labs.
\nYou will have the opportunity to have an immediate and lasting impact to our diverse pipeline.
\nThe 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.
\nIn this role you will interact closely with Bioanalytical leads, CROs, study management, leadership team of iBA, CPSS functional representatives, other key stake holder functions to ensure quality and timely bioanalytical support of projects.
\nThis is a highly visible role, and you will be required to leverage your scientific knowledge and expertise, organizational and operational skills, while working with a range of stakeholder, and cross functional groups and gain alignment on strategies and deliverables.
\nYou 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.
\nYou 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.
\nAs 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.
\nAs a senior member 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.
\nThe successful candidate will work closely with AstraZeneca global groups, serve as the leader of IBA project teams (select projects), partner with other members and leaders in IBA, external vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery for multiple modalities including, ADCs, RCs, biologics, cell, small molecule pipeline while fostering an environment of scientific knowledge exchange.
\nThey will also interact with stakeholders and cross functional project teams.
\nEducation/Experience:
\nExperienced in serving as a project representative, worked with stakeholders, experienced in drug development process and regulatory filings.
\nEssential for the role:
\nDesirable for the role:
\nWhy AstraZeneca?
\nAt AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society.
\nAn inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development.
\nWe’re on an exciting journey to pioneer the future of healthcare. So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
\nThe annual base pay for this position ranges from $175,498.40 - $263,247.60 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and,
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