Associate Director Study Leader, Early Oncology Clinical
- Experience Level
- Senior Management
At AstraZeneca, we're not afraid to do things differently. We're building a new kind of
organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening up new ways to work, pioneering ground-breaking methods and bringing teams together.
We are hiring within our Oncology R&D department, and currently have a vacancy for an
Associate Director Study Leader.
This office based position could be located in Cambridge ~ UK, Gaithersburg - US, Boston ~ US.
Don't hesitate to click on apply, and join us in working on one of the most promising Oncology pipelines in the industry!
The Associate Director Study Leader (ADSL) is responsible for delivering a single or several smaller development programs or leading multiple studies or single complex/novel studies such as platform, basket, etc. The exact accountabilities will differ depending on the exact
nature of the program so a high degree of flexibility and autonomy is required. The ADSL may also provide expert input to other non-drug programs and improvement projects.
Typical Accountabilities Include:
- 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
- Ensure sponsor oversight throughout the life of the study
- Develops and manages risk management/mitigation plans to ensure timely delivery to quality, budget and time and raise issues to partners as the need arises
- Responsible for planning and leading issue escalation and resolution
- Provide input to forecasting and management of study 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 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 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
Education, Qualifications, Skills and Experience Essential
- Bachelor's degree in related subject area, preferably in medical or biological science.
- Extensive drug development experience demonstrated in a variety of roles
- Demonstrated ability in leading studies/programs in clinical development
- Extensive knowledge of the clinical and pharmaceutical drug development process
- Extensive and proven experience in driving operational delivery to timelines, cost and quality
- Proven experience leading delivery through internal and external organizations.
- Excellent knowledge of ICH-GCP principles
- Project Management experience within the context of Clinical Drug Development
- Experience and strength in working and leading in matrix teams
- Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict
- Proven track record in problem solving and issues management that is solution focused
- Ability to lead strategic and/or operational management of individual clinical trials
- Experience in providing clear requirements for external contracts
- Experience in selection of external providers and development/review of contracts
- Proven oversight of external providers
- 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 of early phase clinical delivery
Does this describe you? If so...don't hesitate in applying today and you could be joining us soon!!