Director Study Leader - Cell Therapy

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 Director Study Leader, Cell Therapy delivers a single or several smaller Cell Therapy development programs or leads multiple Cell Therapy studies or single complex/novel studies such as platform, basket. The exact accountabilities will differ depending on the nature of the clinical studies or program. You will report to the Sr. Director Group Leader, Cell Therapy or equivalent.

The Director Study Leader, Cell Therapy may provide expert input to other non-drug programs and process improvement projects.

Responsibilities

• Provide expert clinical operational input into project or study level documents and may lead the delivery of study documents.
• With oversight from the Clinical Program Director, Cell Therapy may lead and deliver unique and 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
• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative
• Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program.
• Implement agreed study level process and technology for assigned Cell Therapy clinical studies.
• Manage risk management/mitigation plans to ensure delivery to quality, budget and time and escalate issues to partners
• Provide input to forecasting and management of study delivery costs, resource, and timelines
• Accountable for the quality of study/program planning information into relevant planning systems (e.g, PLANIT) in collaboration with counterpart in relevant therapeutic area
• May guide the Study Team in the development of outsourcing specifications and vendor selection.
• Provision to procurement clear specifications for study or program specific outsourcing
• Perform review and operational approval of study or program specific contracts or work orders
• Responsible for oversight of CROs and other clinically outsourced third-party vendors
• Communicate study level reports and status updates for assigned Cell Therapy studies, including progress issues
• Lead risk management and quality efforts to ensure study compliance and inspection readiness for apheresis and cell therapy infusion activities
• May lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical QA for apheresis and cell therapy infusion activities
• Contribute to operational interactions with external entities including regulatory agencies, preferred partners/suppliers, and external collaborators
• Oversee the submission of trial-related and essential documents to the Trial Master File, maintenance and final closeout.

Supervisory Responsibilities

• May have 5 direct/indirect reports

Education and Experience

• Bachelor's degree in related discipline in medical or biological science.
• 10 years drug development experience demonstrated in multiple roles
• 5 years of experience leading studies/programs in clinical development
• Comprehensive knowledge of the clinical drug development process
• Experience leading delivery through internal and external organizations.
• Excellent knowledge of ICH-GCP principles
• Experience in selection and oversight of external providers and development/providing clear requirements of contracts
• Experience in variety of academic/CRO/Sponsor organizations and countries
• Experience of early phase clinical delivery and in autologous or allogeneic therapies in oncology

When we put unexpected teams in the same room, we fuel 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 three 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.

The annual base salary for this position ranges from $174,000 to $212,000. 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.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

DE&I Statement

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.