Director, Lab Operations and Diagnostic Deployment

Director, Lab Operations and Diagnostic Deployment

Location: Cambridge (on-site)

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

Precision Medicine & Biosamples within AstraZeneca focuses on matching medicines to those patients who will benefit from them most and delivers companion or complementary diagnostic assays that align with the drug development process and enable personalised healthcare approaches within our clinical portfolio. 

Come and join our AZ team where you will play a pivotal role in this exciting period of development!!

We are looking for a highly collaborative Director who will be accountable for leading AZ clinical trial diagnostic testing and reporting within our accredited diagnostic laboratory at the Cambridge Biomedical Campus. This laboratory deploys new and novel diagnostic assays as well as serving as a diagnostic testing site for our drug and companion diagnostic development programs. This role will involve leading deployment, validation and operational delivery of novel and existing tissue and molecular based diagnostics within an accredited laboratory environment. 

The current portfolio is focused mainly on immunohistochemistry and computational pathology; the role would suit an experienced lab operations leader or pathologist with a background in IHC diagnostic development and operations. The role holder will lead the oversight of assay validation, day to day operations of the accredited lab, and serve as a knowledge expert in the delivery and performance of assays to support our development needs. 

Working closely with colleagues within Precision Medicine & Biosamples, as well as teams throughout AstraZeneca, you will deliver regulatory-compliant workflows within our accredited lab. The role also includes collaboration with external diagnostic partners and testing laboratories. 

As a key member of the Precision Medicine and Biosamples team the role-holder will have responsibility for line and/or project matrix management of staff members. The incumbent will ensure that all activities are delivered demonstrating behaviours and values aligned to the AstraZeneca code of conduct and supporting policies, standards and procedures including compliant management of budget, safety, health and environment. 

Requirements:

• Medical or biological degree

• Relevant qualifications and experience in diagnostic/research histopathology

• Experience of leading in a dynamic testing laboratory, for example NHS, CAP-CLIA or diagnostic company

• Experience in validating and integrating tissued based assays in a regulated environment e.g. under IVDR, ISO13485, ISO15189 or within a CAP/CLIA laboratory

• Experience in IHC and ideally digital pathology

• Ability to lead projects and teams in a matrix environment

• Ability to communicate clearly and influence stakeholders while keeping balanced and objective views

Desirables: 

• Board-certification in Anatomic and/or Clinical Pathology or possess equivalent qualifications

• Experience CAP-CLIA laboratory standards

• Demonstration of a broad lab-based science and technical background

• Understanding ofPrecision Medicine approaches and diagnostic development in Oncology

• Experience interacting with In Vitro Diagnostics regulatory authorities

• Proven track record of working with third parties, both commercial and academic

In Office Requirement: 

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of five days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca? 

At AstraZeneca's Oncology R&D business area, you'll be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients' conditions. We're actively embracing and investing in technology, harnessing digital, data and analytics to reimagine the future of healthcare and deliver improved outcomes to patients beyond core medical. We're shaping the future, improving and speeding up portfolio development, improving the patient experience and outcomes at clinical trials. Join the team that is co-creating a digital ecosystem with patients at its core. 

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.