Director, Oncology Bioanalytical Strategy Lead

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 pharmacokinetics (PK), immunogenicity, and biomarkers to support the AstraZeneca pipeline. You will be closely involved in supporting selected oncology portfolio programs by engaging with key stakeholder functions on project teams and subteams, developing holistic bioanalytical strategies, and working closely with internal and external laboratory and CRO teams to ensure the development and validation of assays aligned with their intended context of use. You will serve as the IBA project lead for selected programs, ensuring the development of sound bioanalytical assay designs and their implementation. This will involve close collaboration with IBA scientific and technical laboratory staff, as well as cross-functional stakeholders. The ideal candidate will have a strong track record in regulated bioanalysis supporting therapeutic modalities in oncology and immuno-oncology. Experience supporting antibody-drug conjugates, radioconjugates, or T-cell engagers (TCEs), in addition to traditional biologics, and a background in immunology and immunogenicity are highly desirable. In this dynamic, matrixed environment, you will be responsible for managing stakeholder expectations, contributing to project strategy and delivery, and serving as the primary interface with highly skilled bioanalytical scientists within IBA and our partner laboratories. You will have the opportunity to make an immediate and lasting impact on 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 U.S. research hubs in Gaithersburg, Maryland, or Boston, Massachusetts, 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 bioanalytical leads, CROs, study management, the IBA leadership team, CPSS functional representatives, and other key stakeholder functions to ensure high-quality and timely bioanalytical support for projects. This is a highly visible role, and you will be expected to leverage your scientific knowledge and expertise, organizational capabilities, and operational skills while working with a range of stakeholders and cross-functional groups to gain alignment on strategies and deliverables. You will apply your experience and proven track record in 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 multiple 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 IBA’s reputation for scientific excellence by presenting at internal and external meetings and publishing manuscripts. As a senior member of the IBA Global Oncology Strategy team, you will be expected to contribute to strategic initiatives aimed at the continued evolution and establishment of the department as a scientific leader and strategic partner. The successful candidate will work closely with AstraZeneca’s global teams, serve as the IBA project team leader for selected projects, and partner with other IBA members and leaders and