Director Study Leader, Cell Therapy

Do you have expertise in Oncology, and experience with cell therapy? As an Director, Study Leader Cell Therapy, Clinical Operations, you will deliver a single or several smaller Cell Therapy development programs. Join us to apply your expertise to affect the lives of patients living with cancer, follow the science, and turn ideas into life-changing medicines. You will report to the Executive Director, Solid Tumor Cell Therapy Clinical Operations.

You Will:

• Clinical Operations delivery of a single or several smaller development programs or leading multiple studies or single novel studies. The exact accountabilities will differ depending on the exact nature of the clinical program.

• Provide clinical operational input into project or study level documents, for example, clinical development plan, clinical study protocol, clinical study report, and may oversee the delivery of study documents

• Lead and deliver unique 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 by close interaction with individual study/program leaders or leadership of the study team

• Ensure sponsor oversight throughout the life of the study

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

• Responsible for planning and leading issue customer concern and resolution

• 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

• Contribute to operational interactions with external entities, including regulatory agencies, preferred partners/suppliers, and external collaborators

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

• Responsible for study-level reporting of progress and risks

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

• Provide procurement clear specifications for study or program-specific outsourcing

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

• May also provide input to other non-drug programs and improvement projects.

You Have:

• Bachelor’s degree in related subject area in medical or biological science.

• A minimum of eight (8)years of drug development experience from within the pharmaceutical or biotech industries

Required Skills:

• Clinical Operations and Cell Therapy or Gene Therapy experience

• Experience driving operational delivery to timelines, cost and quality

• Shown experience leading delivery through internal and external organizations.

• Excellent knowledge of ICH-GCP principles

• Experience and strength in working and leading in matrix teams

• Collaborative and ability to engage with a diverse client base and lead through conflict

• Track record in issues management that is solution focused

• Strategic and operational management of individual clinical trials

• Experience providing clear requirements for external contracts

• Experience in selection of external providers and review of contracts

• Confirmed oversight of external providers

Desirable Skills:

• Program management qualification (e.g. MBA, PRINCE2, PMP) within the context of Clinical Drug Development

• Experience in different academic/CRO/Sponsor organizations and countries

• Experience of early-phase clinical delivery

Our Benefits:

Benefits offered include:

• A qualified retirement program [401(k) plan]

• Paid vacation, holidays, and paid leaves

• Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The annual base salary for this position ranges from $162,566 to $243,849. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

#celltherapy #LI-Onsite

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 authorisation and employment eligibility verification requirements.