Head of Early Phase Clinical Operations - CVRM
AstraZeneca

Job Info

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Head of Early Phase Clinical Operations CVRM

Gaithersburg, US or Cambridge, UK

Competitive salary and Benefits

Make a more meaningful impact to patients' lives around the globe

Here you'll have the opportunity to make a meaningful 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 shaping the patient ecosystem.

Join the team that follows the science unlike anywhere else. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs.

Early Phase Clinical Operations is responsible for the program management of clinical programs and clinical studies designed to generate clinical evidence in our early phase assets. This involves overseeing strategy and planning of assets from the time of Candidate Drug Investment Decisions (CDID) with the subsequent execution of first in human studies through the completion of the phase IIa/IIb studies before programs transition into the pivotal phase III studies. Clinical and translational scientific expertise in CVRM, deep experience in clinical drug development in either the biotechnology and/or pharmaceutical industry, extensive program management skills, and effective leadership of cross functional teams are critical capabilities that underlie this role to ensure that TA-specific strategic plans developed by the early Global Product Teams (eGPTs) are translated into action and that early phase clinical studies meet agreed upon timelines and deliverables.

You will report into the VP, and be accountable for ensuring the early phase clinical trials portfolio progresses forward and is delivered to time, quality, and cost. You're required to work with TA Early Clinical Development, TA Translational Science and Experimental Medicine, eGPTs, Clinical Project Teams (CPTs), Biometrics, Clinical Pharmacology, Patient Safety, and Regulatory Affairs TA Leads as well as other Clinical Operations and Digital Health shared functions, to ensure robust strategic and operational planning has been incorporated throughout the governance process, to oversee delivery of projects and programs to plans while driving standardization and operational excellence across a portfolio of work.

Additionally, you will work closely with the TA Study Management Lead to ensure that fit-for-purpose study delivery models are developed and implemented routinely for healthy volunteer studies, phase Ib, and phase IIa/IIb studies within the TA. Acting as the key business lead for the early phase TA, you'll work in partnership with the alliance manager, for the phase I/FIH alliance and be responsible for working across the R&D organization representing Early Clinical Operations in Operational Excellence and/or transformation activities and is expected to lead and participate in peer/technical reviews and governance meetings as needed.

As a member of the Clinical Operations TA leadership team and the TA Early Clinical Development Leadership team you will be accountable for management, development, and evolution of the Early Phase Clinical Operations team.

Typical Accountabilities

• Functional leadership, recruitment, capability build, individual development and performance management of assigned TA Clinical Operations staff, eg Senior Clinical Program Directors (Sr. CPDs), Section Program Directors, and Clinical Program Directors (CPDs)
  
• Establish, direct and provide strategic global leadership for Early TA Clinical Operations staff working on clinical programs in scope/portfolio
  
• Ensure delivery of all the operational and clinical development components of the global clinical programs within scope
  
• Build strong relationships with TA Early Clinical Development, TA Translational Science and Experimental Medicine, SMM, eGPTs & CPTs, Regulatory, Biometrics, BioPharmaceuticals Clinical Operations, and Digital Health leaders and colleagues to ensure strong collaborations with respect to early phase clinical study design and early phase clinical trial delivery planning and execution
  
• Close collaboration with Late Phase TA Clinical Operations colleagues to ensure successful asset transitions from early phase clinical studies through late phase clinical studies and that there is successful operational planning and strategy development for asset transitions from phase II to phase III programs
  
• Assist the Head of TA Clinical Operations in communicating the science, business priorities and vision to early phase program facing staff ensuring understanding of the
  

TALT portfolio strategy, scientific concepts that underlie the key disease areas of interest, and the unmet clinical need for which compounds are being developed to address

• Evaluate the feasibility of new endpoints and review digital health initiatives and ensure they are appropriately incorporated into clinical study plans
  
• As delegated by the VP, Head of TA Clinical Operations, participate in and significantly contribute to internal program/study review meetings that precede key governance decision meetings including Early Clinical Review Committee (eCRC), TA Early Research Board, Protocol Review Committee (PRC)
  

Essential criteria:

• Advanced degree (Ph.D. in a scientific field is strongly preferred), and equivalent work experience
  
• Extensive early-stage clinical drug development experience ideally including time in a role such as a clinical program director at Sr. Director level or equivalent, which includes working with clinicians, scientists, and clinical trial research sites
  
• Experience in and/or deep understanding of translational research
  
• Relevant therapeutic experience and proven ability to learn new indications
  
• Proven global line management expertise; experience of performance management and development of Director+ level staff
  
• Proven experience in leading and implementing novel technology or techniques in the context of clinical development
  
• Proven change management experience
  
• Proven strategic and innovative thinking
  
• Demonstrated ability in influencing others in a matrix environment
  
• Functional management experience, managing resourcing and budget planning/oversight
  
• Awareness of external competitive environment and operational practices
  
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment
  
• Excellent written and verbal communication skills
  
• Willingness to travel both domestic and international
  
• Proven ability to develop successful collaborations with internal and external partners
  
• Maintains high standards, including a commitment to AstraZeneca values, policies and employment principles.
  

Desirable criteria:

• Master of Science or Post-Doctoral degree in a scientific, public health, bioinformatics, or clinical research discipline
  
• Significant experience in Clinical Development with knowledge of global operational program management and delivery
  
• Demonstrated scientific progress and publication track record
  
• Established and well-connected network with other Early/Late TA Leaders and Clinical Operations Leadership
  
• Proven experience in project management
  
• Comprehensive knowledge of clinical and pharmaceutical drug development processes in relevant TA
  
• Experience working internationally: working with major markets/resolution of international issues
  
• Business planning skills: has knowledge/experience of planning processes used in managing drug projects
  
• Risk and crisis management experience
  
• Manage project budget to threshold for assigned work packages.
  

At 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. Always committed to lifelong learning, growth and development.

This role is open until 16th February 2023.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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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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