Senior Global Clinical Operations Program Director - Late CVRM

Are you passionate about science and have an extensive knowledge within the pharmaceutical industry? Are you also experienced within clinical operations and project management? At AstraZeneca, we work at the cutting edge of science to develop ground-breaking treatments for patients to meet their unmet needs. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality, by doing the right things. Does this match your skills and ambitions for the future? Then join us to discover future treatments of Cardiovascular, Renal and Metabolic diseases!

As out portfolio is expanding we are now recruiting a Senior Clinical Operations Program Director to the Clinical Operations function of Late Stage Development Cardiovascular, Renal and Metabolic therapy area in BioPharmaceuticals R&D. This role can be based at AstraZeneca's dynamic R&D sites in Gothenburg (Sweden) or Gaithersburg (US).



What you'll do

The Senior Clinical Operations Program Director (Sr GPD) is responsible for program leadership and management of all clinical operations deliverable to scope, quality, budget, time resource and risk, ensuring new innovative solutions, design and delivery models are adopted in the clinical development programs. The Sr GPD is one of three core member of the Clinical Program Team (CPT) a strategic and operational leadership team whose remit is to maximize the scientific and clinical relevance of Late CVRM led projects and deliver the assessment of clinical Benefit/risk and clinical development program to the Global Product team (GPT).

Other responsibilities include:

* Effectively partner with the Global Clinical Head (GCH) and Global Project Statistician (GPS) to provide clear direction and aligned goals to the CPT members/delivery teams
*

Responsible/accountable for cross functional leadership e.g. driving cross functional GPT activities
*

Accountable for efficient and effective program management of all GPT clinical development deliverables, including project strategy, design and delivery of CPT driven program/studies to time, on budget and with quality
*

Responsible for clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports and clinical contributions to inspection readiness.
*

Accountable for oversight of all clinical operations activities within the program and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, Risk based Quality Management and external partner management)
*

Acts as the initial and program-level AZ interface with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
*

Ensure alignment of the clinical strategy, transfer of product knowledge and champion products that are between early and late stage organizations
*

Be early adopters for new ways of working and act as ambassadors for change
*

Responsible for leadership and program management of non-drug project work as assigned, eg cross functional improvement initiatives
*

Responsible for ensuring timely compliance with companywide governance controls



Essential for the role:

*

Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience (Advanced degree is preferred).
*

Minimum 10 years' global drug development leadership or equivalent leadership experience demonstrated in a variety of roles. Experience across the product life cycle with extensive experience in late stage development (including regulatory submissions) and ideally across multiple therapeutic areas.
*

Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
*

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
*

Proven teamwork and ability to work collaboratively across a wide range of disciplines and a track record of planning and delivery success both internal and external
*

Strong strategic influencing skills; ability to influence broadly within and outside the organization
*

Excellent written and verbal communication skills
*

Proven teamwork and ability to work collaboratively across a wide range of disciplines
*

Track record of planning and delivery success and leading teams through change
*

Experience of and insight into the Clinical environment to be able to drive major improvement programs



So, what's next?

We welcome your application, no later than August 15, 2021. We will review the applications continuously, so please apply as soon as possible!