Senior Director, Cell Therapy Clinical Operations

Senior Director, Cell Therapy Clinical Operations

Location: Macclesfield

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.

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

The Senior Director – Cell Therapy Clinical Programs & Study Operations (CPSO) is accountable for all study operations (incl. vein-to-vein logistics) of one or more Cell Therapy clinical programs and is the functional representative at the Global Project Team (GPT) level. Key accountabilities include strategic planning, execution and monitoring of all operational aspects related to Cell Therapy clinical studies within the program(s). The Sr Director – Cell Therapy CPSO reports into the Head of the Cell Therapy Clinical Group (CTCG) in Early Oncology and typically has direct reports, although initially or in specific circumstances could be an individual leader operating in matrix functional environment.

In this specific position, the Sr. Director – Cell Therapy CPSO will additionally lead the integration and the build of a cross-therapeutic area Cell Therapy Clinical Operations organisation, including collaboration with Haematology, BioPharma and China R&D. This position demands strong collaborative and communication skills, including the ability to engage with and influence a diverse range of collaborators within the CTCG and the larger organisation.

Key Responsibilities:

• Represents the Cell Therapy Clinical Operations function for one or more programs at GPT level.

• Accountable for the overall Clinical Operations strategy, execution and monitoring of Cell Therapy studies at Clinical Project Team (CPT) level.

• Typically delegates the execution of a clinical study to one or more Study Leader(s), who may or may not report into them, but may act as Study Leader themselves if needed

• Provides input to the Clinical Development strategy from a planning and operational perspective.

• As direct manager, leads, develop and is involved in the recruitment of people; as indirect manager, influences team members within the CTCG (including Physicians and Scientists) and in the larger organisation

• Interacts with other functional leaders, such as Biometrics, Regulatory, Translational Medicine, Patient Safety, Clinical Pharmacology
  

Requirements:

• University degree in related field, preferably in medical or biological science, or field associated with Clinical Research

• At least 10 years global drug development leadership experience with progressive levels of responsibility.

• More than 5 years line management experience

• Experience with leading Cell Therapy clinical studies in Oncology early and/or late development

• Comprehensive knowledge of the clinical and pharmaceutical drug development process

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

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

• Experience of working with and delivering through strategic partners and third party vendors

• Excellent knowledge of ICH-GCP principles

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

Desirables:

• Higher degree e.g. PhD, MSc, MPhil, MBA

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

• Experience of outside Oncology (eg autoimmunity)

• Experience with leading studies in geographies other than US/Europe (eg China, Japan)

• Experience with next-generation products aimed at enhancing potency and reducing vein-to-vein time
  

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!

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.