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 PK ,   immunogenicity   and biomarkers to support the AstraZeneca pipeline. You 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. Yo u 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 . The ideal candidate will have a strong history in regulated bioanalysis supporting therapeutic modalities across   Oncology/Immuno-oncology.    Experience in supporting Antibody-drug   or Radio- Conjugate s or TCEs,   in   addition to traditional biologics and background in   immunology/immunogenicity   is desired .    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 the   highly skilled bioanalytical scientist colleagues within   iBA   and/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 rese arch hubs in   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 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. This 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. 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   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.   The successful candidate will work closely with AstraZeneca global groups,   serve as the leader of IBA project teams (select projects),   partner with other   members and l eaders 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. They will also interact with stakeholders and   cross functional   project teams.   Education/Experience :   Master's in immunology, molecular biology, or related studies with   minimum   of 10+ years relevant experience; OR PhD in immunology, molecular biology, or related studies with   minimum   of 7+ years relevant experience in   Biopharmaceutical   industry .  Experienced in serving as a project representative, worked with stakeholders, experienced in drug development process and regulatory filings.   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 in regulated bioanalysis , in-depth knowledge of complex biologics   and/or   bioanalysis of ADCs and related modalities   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 a range of analytical techniques such as   Ligand binding assays, LC-MS, molecular assays   ( ddPCR , qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays .   Experienced in assay transfer, scientific quality, and study conduct at CRO partners, data analysis and interpretation, delivery of preclinical and clinical data to project teams.   Deep understanding of global regulatory expectations and guidance in relevant areas   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, a