Would you like have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us!!

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.

Site description

Welcome to Cambridge, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you…

Where Science thrives…Cambridge is one of the most exciting bioscience hotspots in the world, playing a central role in our mission to deliver life changing medicines to patients across the globe.

This role could be located in either the Melbourn Science Park or the Central Cambridge offices.

Located in stunning offices set in 17 acres of landscaped grounds. The Melbourn Science Park offers an impressive mix of refurbished open plan office space on two floors and a suite of fully furnished conference and meeting rooms. The building benefits from a full height atrium and stunning views overlooking the lake.

Central Cambridge – Located in walking distance from the Train station, you will have access to an onsite gym, restaurant facilities and experience working within a calm and relaxing agile environment, inspired by the University Botanical gardens.

Both sites provide access to a stylish, fully air conditioned fitness centre, an onsite restaurant, Lunch & Learn development activities, all within a forward-thinking and spacious environment while utilising the most advanced technology.

Business area

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us. A place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take calculated risks that write the next chapter for our pipeline and Oncology team.

We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early stage cancer trials in the industry, we are getting closer to finding cures every day.

It’s our unique people-first approach that keeps us grounded and inspired to improve outcomes for all. Listening to our patients to evolve with their needs and tailor their medicines.

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

What you’ll do

The Associate Director Study Leader, Early Oncology Clinical is responsible for the delivery of clinical studies including quality, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. Provides matrix management of functional area representatives to cross functional clinical study teams. Duties include:

• Leads the delivery of the clinical study from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards.

• May convene and lead the cross functional study team(s) for Early Oncology Clinical studies based on delivery model

• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative

• Contribute to preparation and delivery of study documents (e.g. Protocols/amendments, Informed Consent Form (ICF) documents detailing study delivery data management activities, etc.)

• Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment

• Leads study recruitment and data delivery to agreed timelines and targets

• Implement agreed study level process and technology for Early Oncology clinical studies

• Lead to the agreed study timelines, budget, and resource and ensure the update of appropriate systems

• Accountable for the quality of study planning information into relevant planning systems

• Guide the study team in the development of outsourcing specifications and vendor selection

• May handle the vendor(s) throughout the life of assigned clinical trial(s) based on delivery model

• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs

• Lead and conduct investigator meetings and other study related meetings

• Identify and communicate resource gaps for assigned studies

• Communicate study level reports and status updates for Early Oncology clinical studies

• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance

• Oversee the submission of trial-related and essential documents to the Trial Master File, maintenance and final closeout of TMF

• Ensure sponsor oversight throughout the life of the study

• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness

• Responsible for study level reporting of progress, risks and issues

• Provision to procurement clear specifications for study specific outsourcing

• Review and operational approval of study specific contracts or work orders
  

Required Experience, Skills, and Qualifications

• Bachelor’s degree in related field, preferably in medical or biological science

• Minimum of 5 -7 years progressive experience in clinical research, with at least 3 years of global study leadership or equivalent

• Comprehensive knowledge of the clinical and pharmaceutical drug development process

• Excellent knowledge of ICH-GCP principles

• Extensive and shown experience in driving operational delivery to timelines, cost and quality

• Shown experience leading delivery through internal and external organizations

• Experience and strength in working and leading in matrix teams

• Strong collaborative communications skills including the ability to engage with a diverse client base and lead through conflict

• Proven ability in problem solving and issues management that is solution focused

• Experience in providing clear requirements for external contracts

• Experience in selection of external providers and development/review of contracts

• Proven oversight of external providers

• Experience of early phase oncology clinical delivery
  

Desired requirements

• Higher degree e.g. PhD, MSc, MPhil

• Program management qualification (e.g. MBA, PRINCE2, PMP)

• Experience in variety of academic/CRO/Sponsor organisations and countries
  

Why AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s 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. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next:

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.

Closing date: 24th June 2022

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.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. Accordingly, AstraZeneca requires all US employees to be fully vaccinated for COVID-19 prior to the first date of employment. AstraZeneca will consider requests for reasonable accommodations as required by applicable law.