Senior Director Group Clinical Programs
AstraZenecaUs - waltham - maUpdate time: September 11,2021
Job Description

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously craft partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.

AstraZeneca is committed to advancing the science of oncology to deliver life-changing medicines to patients with a pipeline that exploits the power of four scientific platforms (Tumour Drivers and Resistance, DNA Damage Response, Immuno-Oncology, Antibody-Drug Conjugates).We currently have nearly 100 Phase 1, 2, 3 and Lifecycle Management Oncology projects in our robust pipeline.

This is an exciting period for us, as well as for you to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science. We enable the business to make critical pipeline and investment decisions and to ensure they select the right molecules to progress and to seize the right lifecycle management opportunities. You can play a role by helping to generate the data required to drive regulatory submissions for new medicines and expanded indications and generating the evidence that shows their value.

Within the Early Oncology ICA Group, a vacancy has arisen for a Senior Director Group Clinical Programs (GDCP). In this role you are a key member of the Translation Medicine Unit (TMU) Leadership Team and you also carry project direction and line management accountabilities. You will be office based in Cambridge, UK.

Where operational work is outsourced, you are responsible for the coordination and selection of providers and providing requirements for the contract. You will also be the operational signature for all study/project specific contracts or work orders and you are expected to ensure standard methodology oversight of any external providers.

In addition, you may be required to fulfil the role of line manager to other Directors Scientific Project Management (DSPM) and/or Associate Directors Study Management (ADSM). You may act as the Skills Lead for the DSPM and/or ADSM groups. As a result you are tasked to ensure that appropriate procedures, training and personal development approaches are in place for the skill group. In the project axis, your oversight could include groups of projects e.g. according to disease type and/or mechanism of action. You may represent their TMU in other forums within and outside Early Clinical Development (ECD). You may have to take an executive or lead operational role in managing key alliances (provider, academic, development partners). You may need to serve as a member of the Departmental Leadership Team (DLT), coordinate resource forecast, assignment and tracking and lead improvement initiatives in service of functional scorecard objectives.

Your key responsibilities:

  • Delivery and execution of the integrated clinical program output (both AZ sponsored and non-AZ sponsored clinical trials) within agreed tolerances (time, scope, quality and cost)
  • Clinical program project management tasks, including forecasting and securing clinical resources for the project in partnership with ECD leaders and Project Leaders (latter accountable for securing non-clinical resources). Management of risk, financial management and accurate input to capacity management. Ensure accuracy of resource and cost forecasts versus actuals.
  • Accountable for delivering differentiated and robust operational options for content of clinical programs for review at Investment Decision Governance interactions
  • Accountable for leading the operational delivery of the Clinical Study Program from design to final CSR and through to study closed and archived to agreed budget, time and quality and aligned with set targets
  • Accountable for planning and leading issue reporting and resolution
  • Input to the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • Accountable for the quality of study delivery planning information into meaningful planning systems (e.g. IMPACT, OPAL)
  • Accountable for ensuring timely compliance with company-wide governance controls
  • Provision to procurement of clear specifications for program/study specific outsourcing
  • Run operational management and oversight of external providers at program/study level
  • Reporting of progress, risks and issues to management and other business partners
  • Contributes to the DLT to ensure effective ways of working, identification and resolution of issues and departmental objective setting. This may extend to resource allocation and tracking at the departmental level and represent Oncology TMU in Capacity Management Forums

What do we need from you?

Minimum Requirements

Education:

  • Bachelor of Science degree in scientific subject area, preferably in medical or biological science.
  • Advanced degree is advantageous.

Experience:

  • Extensive experience within global drug development leadership, demonstrated in a variety of roles, including within a clinical function
  • Comprehensive knowledge of clinical & pharmaceutical drug development process
  • Experience in developing programs to meet business goals and to assess business risk versus potential value. The ability to understand global business requirement
  • Significant experience of program management and use of project management techniques in complex projects, including resourcing and financial management
  • Strong strategic influencing skills
  • Significant experience and expertise in Clinical Trial methodology. A track record in delivering differentiated options based on a sound knowledge of operational delivery
  • Solution focused skills in problem solving and issues management
  • Extensive and proven experience in driving operational delivery to timelines, cost and quality
  • Proven experience of leading delivery through collaboration with interface organization and external providers
  • Experience in managing and selection of external partners and development/review of contract
  • A clear demonstration of behaviors. Truth seeking rather than success seeking, agile responsiveness to scientific data, embracing of peer review and agnostic to internal-external sourcing

Next steps ~ Apply now

Competitive Salary and Benefits Apply!

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 great fit, please share this posting with them.

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 status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Date Posted

10-Sep-2021

Closing Date

08-Oct-2021

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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