The Director – Cell Therapy Operations has a sizeable scope, including accountability for the operational design inputs to deliver the assigned program(s) as part of the product development team. Within a program, they maintain accountability for the delivery and reporting of clinical studies to time, quality, and cost. The Director - Cell Therapy Operations is a key member of the Global Project Team. This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and outside of AstraZeneca.

The Director – Cell Therapy Operations is responsible for the design and implementation of a logistics model ensuring effective scheduling of patients and their cells (apheresis & final drug product) between investigating/treatment sites and the manufacturing facility. They will develop the tools and processes to ensure smooth execution of each step of the patient journey once the patient is either a) enrolled in a clinical trial or b) commercially when a patient is approved for treatment and beginning the treatment course.

The exact accountabilities will differ depending on the stage of the clinical program, so a high degree of flexibility and autonomy is required.

Typical Accountabilities:

• Establish site qualification criteria and conduct operational certification for apheresis/treatment (e.g., FDA Risk Evaluation and Mitigation Strategy (REMS) qualification). Track and maintain site certification and recertification needs

• Manage the operational setup of new apheresis and treatment centers; ensure site training (compliance versus needs / requirements)

• Ensure investigators and site staff have a thorough understanding of processes for treatment execution (e.g., scheduling portal, apheresis and infusion procedures, cell handling, shipping, etc.)

• Build relationships with clinical / commercial site operations personnel (e.g., cell therapy operations managers)

• Collaborate between the Investigator Site, couriers, and internal functions at AstraZeneca, namely Manufacturing, Supply Chain, Clinical Operations and Medical/Clinical Science to ensure that patient visits and cell product delivery are coordinated

• Lead patient scheduling and cell management tasks, from confirming apheresis and subsequent dispatch to manufacturing, coordinating courier pick-ups and deliveries, as well as preparation of shipping documentation, communicating product manufacturing milestones to Clinical Sites & coordinating patient visits preparation prior to infusion (chemotherapy conditioning)

• Develop, maintain, and evaluate key performance indicators for patient treatment execution

• Ensure appropriate infrastructure is in place to deliver the treatment, including working with development and commercial leadership to establish and implement an apheresis and treatment center network strategy

• 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 as appropriate

• Use relevant tools and communication with clinical sites, optimize patient and drug scheduling, to optimize the number of patients recruited per site per month/year.

• Develop and manage effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate

• Responsible for planning and leading issue escalation 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

• Mentor and support development of individuals within the organization

• Manage a team of schedulers responsible for scheduling, logistics and support of all AZ cell therapy trials worldwide

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

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

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

• Responsible for provision to procurement clear specifications for study or program-specific outsourcing

• Responsible for review and operational approval of study or program specific contracts or work orders.
  

Education, Qualifications, Skills, and Experience

Essential :

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

• At least 10 years or equivalent experience in drug development leadership experience with progressive levels of responsibility.

• Comprehensive knowledge of the clinical and pharmaceutical drug development process

• Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements

• Significant experience of program management and use of project management techniques in complex projects, including resourcing and financial management

• Strong strategic influencing skills and ability to influence broadly within and outside the organisation

• Significant experience and expertise in Clinical Trial methodology with a proven track record to deliver differentiated options based on a sound knowledge of operational delivery

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

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

• Proven experience of leading delivery through collaboration with internal and external providers

• Excellent knowledge of ICH-GCP principles

• Experience in providing clear requirements for external contracts

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

Desirable :

• Higher degree e.g., PhD, MSc, MPhil

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

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

• Experience across the product life cycle and multiple therapeutic areas

• Experience of early phase clinical delivery

• At least 5 years global drug development experience within clinical function

• Salesforce or other customer management software systems

Date Posted

11-Mar-2024

Closing Date

10-Apr-2024Our 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.