Associate Director Study Leader, Cell Therapy

About AstraZeneca in Gaithersburg, MD :

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 guides in our field and is only a short drive from Washington, DC.

This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all crafted to encouragteamworkon and cross-functional science.

We believe employees benefit from being challenged and inspired at work. We are dedicated to crafting a culture of inclusion and teamwork.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy.

This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while growing teamwork between teams.

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases.

Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Associate Director (AD) Study Leader Cell Therapy delivers a single or several smaller Cell Therapy developments programs or leads multiple Cell Therapy studies or single sophisticated / novel studies such as platform, basket.

The exact accountabilities will differ depending on the nature of the clinical program or study. You will report to the Sr.

Director Group Leader, Cell Therapy or equivalent.

The ADSL may provide experienced input to other non-drug programs and process improvement projects.

Responsibilities

Provide guide clinical operational input into project or study level documents, and may lead the delivery of study documents

With oversight from the Sr. Director Group Leader, Cell Therapy or the Clinical Program Director, Cell Therapy, may lead and deliver operational options for review at Investment Decision Governance interactions

Lead the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards

Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program

Lead risk management / mitigation plans to ensure delivery to quality, budget and time and raise issues to partners.

Provide input to forecasting and management of study / program delivery costs, resource, and timelines

Accountable for the quality of study / program planning information into relevant planning systems

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

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

Provision to procurement clear specifications for study or program specific outsourcing

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

Lead and conduct investigator meetings and other study related meetings. May convene and lead the Study Teams for EO Cell Therapy studies.

Identify areas of standard methodology / process improvements and knowledge share across the Cell Therapy Clinical Group.

Education and Experience

University degree / Bachelor's degree in related field in medical or biological science and a minimum of 5 years experience in clinical research, with at least 3 years of global study leadership or equivalent

Excellent knowledge of ICH-GCP principles

Experience and strength in working and leading in matrix teams

Experience in selection and oversight of external providers and development of contracts

Experience in variety of academic / CRO / Sponsor organizations and countries

Experience in autologous or allogeneic therapies in oncology

The annual base salary for this position ranges from $154,000 to $186,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience.

If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and 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.

Why AstraZeneca?

So, what’s next!

Where can I find out more?

Check out our landing page for more information on our BPD group

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram

Date Posted

24-Jun-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.

We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments / accommodations to help all candidates to perform at their best.

If you have a need for any adjustments / accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.