Clinical Program Director, Early Clinical Development

Early R&I within AstraZeneca is accountable for the discovery and the development (up to phase III) of new drugs in the R&I arena. Clinical Development within Early R&I consists of experienced medical directors, clinical scientists and clinical program directors, who, in a collaborative manner, define clinical development strategy, design innovative clinical trials and translate novel scientific ideas to proof-of-concept in target populations.

We are now recruiting a Clinical Program Director (CPD) within the Early Respiratory & Immunology (Early R&I) Clinical Development Group, in Early R&I BioPharmaceuticals R&D. The successful candidate will join Early R&I Clinical Development focusing on immunological diseases. This position can be placed either in Gothenburg, Sweden, Cambridge, UK or Warzaw, Poland.

What you'll do

In the role as CPD you will be accountable for the overall delivery of the clinical program to time, cost and quality and be the leader of the Clinical Program Team (CPT). The role provides strategic oversight and feasibility input into the design of the clinical program and plays a key role in the work required to determine possible program design options.

The CPD's focus is across the program level, collaborating with all functions that are key to the development of a compound.

The CPD is expected to be a highly experienced drug developer and have organisational understanding and influence. The CPD will drive and guide the CPT and each of its functions and enhance team work, productivity and depth of quality. The CPD is responsible for driving the clinical strategy, implementation and forward planning.

We rely on you to:

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Lead the translation of science into crisp and robust clinical development plans, including operational design options for assigned aspects of the programs
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Be accountable for team leadership to provide clear direction and aligned goals to the CPT members and maintain a high performing clinical program team for the assigned program(s)
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Lead the Clinical Program Team (CPT) and its oversight of clinical program strategy activities within each assigned program.
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Provide strategic and operational input on clinical content to cross-functional program development plans and accountable for cross-functional leadership roles as delegated from the eGPT, e.g., leadership of cross-functional product development team activities pertaining to clinical content.
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Ensure implementation of innovative approaches to delivery with Development Operations, e.g., new delivery platforms and technology to ensure patient insights, patient and site engagement, recruitment and retention
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Provide and ensure expert clinical input into various clinical documents and to support high quality governance and Health Authority interactions
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Act as the initial and program-level AZ operational interface with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
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Accountable for initial feasibility assessment including patient insights and early country and site engagement to assist with formulating budget forecast and trial timelines
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Be accountable for accurate budget forecasting, and maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned program, including setup and maintenance within Company systems, e.g., PLANIT.
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Contribute to driving best practices and support process-related improvements and workstreams, including alignment with digital health, clinical innovation, and ensuring timely compliance with Company governance controls
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Ensure alignment of the clinical strategy, transfer of program knowledge and champion programs that are between early and late stage organizations

Essential for the role

We believe that you hold a Bachelor of Science/Arts degree in a related discipline, preferably in medical or biological science, advanced degree preferred. You have extensive global drug development experience with proven track record of leading and driving operational delivery to timelines, cost and quality through collaboration within globally matrixed teams.

You also possess:

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Leadership and strategic influencing skills with ability to influence broadly within and outside the organisation, motivate team members, and build cross-functional teams.
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Proven ability to develop programmes to meet business goals and to assess business risk versus potential value; ability to understand global business requirements.
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Experience in clinical trial methodology with ability to deliver differentiated options based on sound knowledge of operational delivery.
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Strong collaborative communication skills including ability to engage with diverse client base and manage through conflict
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Strategic skills including high level of creativity, innovation, and problem solving with ability to manage effectively through ambiguity

So, what's next!

If you are ready to make a difference - apply today, and we'll make it happen together!

We welcome your application no later than 21 February, 2021