Senior Global Programme Director - Hematology

AstraZeneca UK

Location: Cambridgeshire, Gaithersburg, Maryland, South San Francisco, California

Job Type: Full time

Posted

Men
16%
Women
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Senior Global Programme Director - Hematology

Locations : Cambridge, UK - Gaithersburg, US - South San Francisco, US - Toronto, Canada.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies.

AstraZeneca has a multifaceted environment that cultivates collaboration and innovation. We attract top minds, and we nurture and build talent.

Business Unit Overview :

Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death. This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programs

What you will do :

The Senior Global Clinical Operations Programme Director (Sr GPD) is a core global role within the Haematology R&D Clinical Operations and is accountable to the Global Product Team (GPT) for the operational delivery of the agreed clinical development plan and is one of three core members of the Clinical Programme Team (CPT), a strategic and operational leadership team whose remit is to maximize the scientific and clinical relevance and value of Haematology led projects. The CPT delivers the Target Product Profile directed strategy and clinical benefit/risk assessment to time, cost and quality to the GPT or equivalent teams.

The Sr GPD is responsible for program leadership and management of all clinical operations deliverables to scope, quality, budget, time, resource and risk, ensuring new innovative design and delivery models are used appropriately. The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with AstraZeneca priorities and strategy. The Sr GPD brings product knowledge and strategic thinking to support governance interactions, leads the delivery of a program of studies and is accountable for the project management of the clinical support of regulatory marketing applications and post registration product maintenance deliverables.

Additionally, the Sr GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas, as well as line potential management of clinical operations personnel.

Typical Accountabilities :

  • Accountable for oversight of all clinical operations activities within the program (Early and Late development), ensuring relevant issues are escalated to GPT (or equivalent team) and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, risk and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
  • Plans, directs and delivers the operational components of assigned clinical programs from design concept to final CSR, through to study closed and archived within agreed budget, time, quality and aligned KPIs
  • Responsible for providing strategic and operational input to cross-functional program development plans, data interpretation and accountable for cross-functional leadership roles as delegated from the Global Project Team, e.g., leadership of cross functional product development team activities. Provide expert clinical operational input into: Target Product Profile (TPP), Clinical Development Plan (CDP), Study Synopsis, Clinical Study Protocol, Clinical Study Report, IB, briefing documents, etc., to ensure seamless delivery of programs through effective collaboration.
  • Engagement with preclinical and translational science as well as statistics and regulatory in order to design and deliver robust clinical development plans.
  • Effectively partner with the Global Clinical Head (GCH), Global Clinical Lead (GCL), and the Biometrics Team Leader to provide leadership, clear direction and aligned goals to the CPT members/clinical delivery teams
  • As a member of the CPT, responsible for efficient and effective program management of all GPT (or equivalent team) clinical development deliverables, including strategy, design and delivery of clinical program/studies to scope, quality, budget, time; managing resource and risk.
  • Accountable for establishing team structure and ways of working to ensure CPT is a high performing team.

Essential Requirements :

  • Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred
  • Experience in Phase 1 dose escalation, registrational Phase 3 trials
  • Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
  • Extensive experience across the product life cycle with experience in late stage development and ideally across multiple therapeutic areas
  • Clinical operations knowledge with strong track record of delivery
  • 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, financial management and business case development

Desirable Requirements :

  • Higher degree e.g. PhD, MD, PharmD
  • Demonstrated ability to drive process improvement and/or functional work
  • Experience of implementing changes in ways of working that focus on increasing efficiency
  • Regulatory submission experience
  • Previous success of working in Japan and China to ensure delivery of global programmes to meet business needs
  • Proven experience in leading teams through change

Competitive Benefits & Salary

Working at AstraZeneca

Here you’ll have the chance to create a substantial difference to patients’ lives! With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.

Next Steps? Apply now!

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.

Find out more and follow AstraZeneca on:

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

21-Sep-2022

Closing Date

29-Sep-2022

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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