Group Director Study Operations, Oncology R&D
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
The Group Director Study Operations is accountable for the management and development of a team of clinical operations specialists supporting the delivery of clinical studies and will lead or participate in functional activities supporting day to day business as well as change and improvement projects.
The Group Director Study Operations may also take on the responsibilities of the Director Study Leader for delivering development programs or leading multiple studies / single complex studies. The exact accountabilities will differ and so a high degree of flexibility and autonomy is required.
Key Responsibilities:
Management, development and career progression of clinical operations specialists
• Recruitment and retention of staff
• Ensure direct reports are appropriately trained and developed to align with company and regulatory standards
• Conduct ongoing performance management and complete the required steps of the performance management cycle Resource management and efficient deployment of staff to clinical studies/programs
• Oversight of quality and compliance of the group to ensure inspection readiness
• Driving efficiencies and innovation across the operational skill group
• Work closely with the Leadership Team to drive strategy and business performance
• Development and maintenance of processes owned by the group
• Driving productivity improvements and innovation within the group
• Lead/participate/represent Study Operations in strategic work streams
In addition to the full line management accountabilities, the Group Director Study Operations may undertake responsibilities of the Director Study Leader, Early Oncology Clinical:
• Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents
• With oversight from the Senior Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
• Leads the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
• Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate
• Ensure sponsor oversight throughout the life of the study
• Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and raise issues to collaborators as appropriate
• Responsible for planning and leading customer concern resolution
• Provide input to forecasting and management of study/program delivery costs, resource and timelines
• Accountable for the quality of study/program planning information into relevant planning systems
Date: September 2021
AstraZeneca Job Profile
• Mentors and supports development of individuals within the organisation
• Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
• Responsible for study or program level reporting of progress, risks and issues
• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
• Provision to procurement clear specifications for study or program specific outsourcing
• Review and operational approval of study or program specific contracts or work orders
Essential Education, Skills & Experience:
University degree in related discipline, preferably in medical or biological science, or discipline associated with Clinical Research
• Significant experience in operational support and delivery in early clinical development
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Team orientated
• Ability to lead, coordinate and prioritise multiple tasks and deliverables
• Proactive approach
• High degree of flexibility
• Demonstrated verbal and written communication skills
• Good negotiation and collaboration skills
• Demonstrated interpersonal and problem-solving skills
• Ability to manage change and actively seek and champion more efficient and effective ways of working
• Some travel may be required
Desired Education, Skills & Experience:
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
• Line management experience
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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailingAZCHumanResources@astrazeneca.com.
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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.
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