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Clinical Program Director, Oncology R&D, Early Oncology Clinical

Lieu Gaithersburg, Maryland, États-Unis Job ID R-088963 Date de publication 08/20/2020

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new ideas to life.

AstraZeneca’s vision in Oncology is to push the boundaries of science to change the practice of medicine, transform the lives of patients living with cancer, and to ultimately eliminate cancer as a cause of death.

If you are inspired by the possibilities of science to make a difference and are ready to discover what you can do, then click on the link below and join us!

Role Description

The Clinical Program Director has a sizeable scope , including accountability for the clinical program strategy and operational design inputs to deliver their 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 Clinical Program Director also provides expert input to other non-assigned drug programmes, and process-related improvements and workstreams.

The Clinical Program Director is a key leadership 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 partners both within and outside of AstraZeneca.

Typical Accountabilities

In collaboration with the Medical Science Director, you would be accountable for the clinical program strategy, including:

  • Innovative ways to delivery, e.g. new delivery platforms and technology to ensure patient engagement, recruitment and retention.
  • 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
  • Leads and delivers differentiated and robust operational options for review at Investment Decision Governance interactions
  • Leads operational discussions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
  • 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.
  • Develops and maintains effective program level risk management/mitigation plans to ensure timely delivery to quality and budget
  • Accountable for planning and leading issue escalation and resolution
  • Accountable for the acquisition of clinical trial data from internal and external sources
  • Input to the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • Accountable for the quality of study delivery planning information into relevant planning systems
  • Ensuring timely compliance with company-wide governance controls (e.g. Sarbanes-Oxley Act of 2002, Delegations of Authority, study attestations, Letter of Assurance, financial system access, Clinical Trial Disclosure)
  • Coordination of selection of external providers for programme/study specific tasks
  • Provision to procurement of clear specifications for program/study specific outsourcing
  • Review / approval of program/study specific contracts or work orders
  • Management and oversight of external providers at program/study level
  • Engagement with preclinical and translational science, as well as statistics and regulatory, in order to design and deliver robust clinical development plans.
  • Develops, coaches, mentors, motivates and inspires individuals within the organization.

Education, Qualifications, Skills and Experience

Essential

  • Bachelor’s degree in related subject area, 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; ability to influence broadly within and outside the organisation
  • Significant experience and expertise in Clinical Trial methodology with a proven ability 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 of external providers and development/review of contracts
  • Proven oversight of external providers

Desirable

  • Higher degree e.g. PhD, MSc, MPhil
  • Program management qualification (e.g. MBA, PRINCE2, PMP)
  • Experience in variety of academic/CRO/Sponsor organisations 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

Competitive Remuneration and generous benefits apply

We are also open to considering the UK as a base for this role - at the Cambridge offices - if this would be your preference, then please apply to the separate advertisement advertised for the Cambridge site as the primary location.

Does this sound like you? If so, don't hesitate in applying today!

We look forward to hearing from you.



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.

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