Group Associate Director - Study Operations Oncology
- Experience Level
- Senior Management
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 bring big new ideas to life and change the course of medicine.
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. Our broad pipeline of next-generation oncology medicines has nearly 100 clinical trials ongoing and a robust pipeline of preclinical therapies!
Come and join our AZ team where you will play a pivotal role in this exciting period of development.
The Early Oncology Clinical Programs & Study Operations group are accountable for delivering high quality, cost efficient early phase clinical studies (phase 1 to phase 2b) that support drug development within Oncology.
We are currently looking to recruit a talented Group Associate Director to join our Early Oncology Clinical group, could this be you?
The Group Associate Director Study Operations will manage and develop 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.
In this role, you may also take on the responsibilities 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. The role is office based in Cambridge, UK.
- Management, development and career progression of clinical operations specialists
- Recruitment and retention of staff
- Ensure direct reports are appropriately trained and developed to comply 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, you may undertake responsibilities of the Associate 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 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
- Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and manage issues to business partners as appropriate
- Responsible for planning and leading issue follow up and 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 planning systems
- 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
- Review and operational approval of study or program specific contracts or work orders
- 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
- Ability to lead, coordinate and prioritise multiple tasks and deliverables
- Proactive approach, a strong sense of flexibility, good negotiation and teamwork skills
- Demonstrated verbal and written communication skills
- Demonstrated interpersonal and problem-solving skills
- Ability to manage change and actively seek and champion more efficient and effective ways of working
- 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
Next Steps? Apply now!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience. It is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a good fit, please share this posting with them.