Director - Clinical Development
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. Do you have the strategic leadership required to be our next Director of Clinical Development in Oncology?
This is a key leadership role within the Clinical Program Team (CPT), responsible for program management of the clinical elements of oncology drug development. We want to redefine the cancer-treatment paradigm, and we aim to bring six new cancer medicines to patients by 2020. Our broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and haematological cancers. As well as other tumour types, these are being targeted through four key platforms: immunotherapy; the genetic drivers of cancer and resistance; DNA damage repair; and antibody drug conjugates. These are all underpinned by personalised healthcare and biomarker technologies.
Within this role you will be driving the late stage clinical development program, integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with Global Medicines Development (GMD) priorities.
Duties and Responsibilities:
As the most senior clinical operations leader, you will be responsible for efficient and effective program management of all GMD clinical development deliverables (scope, quality, budget, time, resource, and risk), including delivery of CPT driven program/studies, clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports, clinical contributions to inspection readiness, governance interactions.
This will include:
- Accountability for oversight of all clinical operations activities within the program and for ensuring provision of clinical operations expertise/input into the program (e.g. country selection, feasibility, operational input into design, external partner management)
- Acting as the initial and program-level AZ operational interface with externally managed/outsourced (e.g. CRO/ARO) partners for program planning of outsourced studies.
- Identification and resolution of issues within the clinical program including the escalation of the issue to the appropriate individual/functional group for resolution. This will also include supporting delivery teams.
- Collaborating with the Global Clinical Leader (GCL), to provide strategic and operational leadership within the program and cross-functional GMD environment Also, partnering with the Global Project Statistician (GPS) and the GCL to provide clear direction and aligned goals to the extended CPT members/delivery teams.
- Ensuring timely compliance with companywide governance controls (e.g. Sarbanes-Oxley, ACCORD access and study attestations, continuous assurance, Clinical Trial Disclosure)
- Cross functional leadership roles as delegated from the GCL and/or GPT e.g. leadership of cross functional GPT activities
- Leadership and program management of non-drug project work as assigned
You will have significant global oncology drug development leadership experience that has been demonstrated in a variety of roles.
- Extensive Clinical operations experience
- Experience across the product life cycle with extensive experience in late stage development
- Considerable experience of program management and development of complex projects, within a global context
- Track record of success in producing business-focused clinical drug development programs
- Strong strategic influencing skills; ability to influence broadly within and outside the organisation
- Proven ability to develop successful collaborations - internally and externally
- Ability to plan and deliver success, and drive major improvement programs
- Proven experience of leading teams strategically and successfully through change
- Degree in a scientific discipline, or equivalent work experience. Postgraduate qualification is preferred
- Willingness to undertake regular international travel
- Experience including regulatory submissions, ideally across multiple therapeutic areas
- Experience within the field of Immuno Oncology
If you are interested, please apply now!
Closing date for applications is 22nd November 2017.
Salary and benefits: Competitive
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership