Director, Oncology Bioanalytical Strategy Lead

As part of the Integrated Bioanalysis (IBA) Global Team you willbe responsible forleading the design and implementation of robust bioanalytical strategies including but not limited to endpoints such as PKimmunogenicityand 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. You will serve as the IBA project lead on the select programs ensure development of sound bioanalytical assay designs and implementation by working closely withiBAscientific and technical staff in the lab as well as with cross-functionalstake holders. The ideal candidate will have a strong history in regulated bioanalysis supporting therapeutic modalities acrossOncology/Immuno-oncology.Experience in supporting Antibody-drugor Radio-Conjugates or TCEsinaddition to traditional biologics and background inimmunology/immunogenicityis 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 interfacewith thehighly skilled bioanalytical scientist colleagues withiniBAand/or our partnered labs. You will have the opportunity to have an immediate and lasting impacttoour 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 belocatedat one of our research hubs intheUS (Gaithersburg MD or Boston MA) where you will work alongside TA leads and stakeholders in CPSS Translational Medicine Research and Clinical this role you will interact closely with Bioanalytical leads CROs study management leadership team ofiBA CPSS functional representatives otherkeystake holderfunctions to ensure quality andtimelybioanalytical support of projects. This is a highly visible role and you willbe requiredtoleverageyour scientific knowledge andexpertise 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 proventrack recorddesigning 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 risksubmitregulatory documents and respond to Health Authority questions. As a Subject Matter Expert you willbe responsible forenhancing the IBA reputation for scientific excellence by presenting at internal and external meetings and publishing manuscripts. As a seniormemberintheiBA-global oncology strategyteamyou 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 groupsserve as the leader of IBA project teams (select projects)partner with othermembers and leaders in IBA external vendor partners to ensure appropriate bioanalytical and platform strategies scientific oversight and delivery for multiple modalities including ADCsRCsbiologics cellsmall moleculepipeline while fostering an environment of scientific knowledge exchange. They will also interact with stakeholders andcross functionalproject teams.

Education/Experience:

• Masters in immunology molecular biology or related studies withminimumof 10 years relevant experience; OR

• PhD in immunology molecular biology or related studies withminimumof 7 years relevant experience inBiopharmaceuticalindustry. 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)PDand immunogenicity assessments (humoral and cellular).

• Experienced in regulated bioanalysis in-depth knowledge of complex biologicsand/orbioanalysis of ADCs and related modalities

• Experienced as a bioanalytical lead in diverse project teams defining leading and implementing robust bioanalyticalstrategyto advance the portfolio.

• Collaborated with stakeholders providing solutions to challenges and mitigating risk.

• Skilledscientistable to discern the advantages of a range of analytical techniques such asLigand 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 ability to prioritize and manage resources.

• Both Line and Matrix management experience ability to coach and mentor senior bioanalytical leads.

• Background in pharmaceutical clinical trial research

• Proven publication and presentation record

• Exceptional verbal and written communication skills
  

Desirable for the role:

• Radio conjugatesCell therapyand or small molecule experience is desired.

• Strong scientific background in immunology ability to support drug programs across multiple therapeutic areas deeperexpertisein flow cytometry.

• Experienced in partnering with operational functions within bioanalysis clinical operations externalCROs to develop efficient processes for bioanalytical execution.

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine patients and society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development. Were on an exciting journey to pioneer the future of healthcare.

So whats next

Are you already imagining yourself joining our team Good because we cant wait to hear from you!

The annual base pay for this position ranges from $175498.40 - $263247.60 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 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 health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.