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 a 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 Director Study Leader (DSL) 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 DSL 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 document

• With oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions

• Leads the delivery of the clinical study program(s) or study(s) from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards

• Accountable for overall study or program deliverables, maintaining oversight by close interaction with individual study leaders or leadership of the study team as appropriate

• Implement agreed study level process and technology for Early Oncology clinical studies

• Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate

• 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 planning information into relevant planning systems (e.g.: IMPACT, PLANIT)

• Guide the study team in the development of outsourcing specifications and vendor selection

• Provision to procurement clear specifications for study or program specific outsourcing

• Review and operational approval of study or program specific contracts or work orders

• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs

• Communicate study level reports and status updates for Early Oncology clinical studies

• Lead and conduct investigator meetings and other study related meetings

• Identify and communicate resource gaps for assigned studies

• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness

• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance

• 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
  

Required Experience, Skills, and Qualifications

• 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

• Experience of early phase clinical delivery
  

Desirable requirements

• 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

Why AstraZeneca

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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next:

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.

Date Posted

Closing Date

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.