Integrated Bioanalysis Lead-Oncology Development

Senior Scientist Integrated Bioanalysis –Oncology Bioanalytical Strategy Lead  

Bold disruptors. Push the boundaries of science. Fearlessly break new ground. 

Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We are looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences. 

What we do 

We are a global, science-led Biopharmaceutical business and our innovative medicines are used by millions of patients worldwide. 

Why we love it. 

The future is bright at AstraZeneca as we bring ground-breaking therapies to complex disease to patients with critical needs. Scientific innovations are at the core of what we do across our industry leading portfolio which drive exciting opportunities and varied work. We are on an exciting journey to pioneer the future of healthcare! 

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, immunogenicity and biomarkers when required to support the AstraZeneca pipeline.  You will be ensuring that lab-based activities are aligned with context of use.  You will work in a matrix environment to manage aspects such as experimental design and tech transfer and will foster close interactions with other scientific and technical staff in the regulated bioanalysis team.  The ideal candidate will have a strong track record in regulated bioanalysis supporting therapeutic modalities across Oncology.  Working with a dynamic team in a matrixed environment, you will need to manage stakeholder expectations and provide 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 our research hub in Gaithersburg, MD where you will work alongside TA leads and stakeholders. In this role you will interact closely with your manager and senior scientists in and outside the lab, and you will be required to set bioanalytical strategies and aid in experimental design and data interpretation of key experiments as needed.  This is a highly visible role, and you will be required to leverage your scientific knowledge and expertise while working with a range of stakeholders and cross functional groups.  You will need to use your experience 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 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. 

The successful candidate will work closely with AstraZeneca laboratory groups within IBA and our vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery of our oncology 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 with significant relevant experience. 

• 3-5 years of experience in bioanalysis

Essential for the role: 

• Experienced as a subject matter expert in regulated bioanalysis across a range of modalities and assays (PK, PD and immunogenicity assessments, humoral and cellular). 

• Ability to work as a bioanalytical lead in diverse project teams, defining, leading and implementing a robust bioanalytical strategy to advance the portfolio. 

• Ability to work collaboratively with stakeholders, providing solutions to challenges and mitigating risk. 

• Ability to discern the advantages and disadvantages of a range of analytical techniques such as ligand binding assays and mass spectrometry flow cytometry, ELISpot, viral assays, cytokine assays. 

• Knowledge of concepts such as context of use of fit for purpose assay validation in bioanalysis. 

• Overseen assay transfer, scientific quality, and study conduct at CRO partners. 

• A good understanding of assay related 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. 

• Data analysis skills to interpret integrated and complex datasets. 

• Ability to handle multiple projects and/or tasks concurrently in a fast-paced environment. 

• Background in pharmaceutical clinical trial research. 

• Proven publication and presentation record. 

• Exceptional verbal and written communication skills. 

Desirable for the role: 

• Experienced in regulated bioanalysis for multiple drug modalities. 

The annual base pay for this position ranges from $109,912.80 - $164,869.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.