Group Director, Clinical Programs

Gaithersburg, Maryland

Posted in Pharmaceuticals
about 1 month ago

This job has expired.

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 exceptional 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, vacancies have arisen for Group Director 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 based in Gaithersburg US or Waltham US.

Where operational work is outsourced you are responsible for coordination of selection of provider 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 programme output (both AZ sponsored and non-AZ sponsored clinical trials) within agreed tolerances (time, scope, quality and cost)
  • Clinical programme 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 programme/study specific outsourcing
  • Run operational management and oversight of external providers at programme/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

  • Bachelor of Science degree in scientific discipline, preferably in medical or biological science.
  • Advanced degree is helpful

  • Extensive late stage Oncology Drug Development experience ideally including time in role as a Director Clinical Development (DCD) or equivalent in a previous organization
  • 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.

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