Associate Director Clinical Development, Immuno-Oncology - Gaithersburg, MD | Biospace
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Associate Director Clinical Development, Immuno-Oncology

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
8/20/2017
Position Type:
Full time
Job Code:
R-006774
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Location: Gaithersburg,
Maryland,
United States
Job reference: R-006774

Posted date: Jul. 03, 2017



At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge 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. As a Clinical Scientist, Oncology you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

Main Duties and Responsibilities

A vacancy has now arisen for an experienced Associate Director, Clinical Development (ADCD) to join our current team. As Associate Director you will be responsible for leading the project planning and operational delivery of clinical work packages in Clinical Operations, GMD. The span of activities is broad covering clinical activities in late drug development, registration/submission and post registration product maintenance phases and will include local and global working.

In this role you will lead and manage defined clinical deliverables across a broad range of activities. This can include the responsibility to lead complex components of a clinical program such as Life Cycle Management, clinical submission activities, or indication development responsibilities or lead independent work packages or maintenance projects. Your responsibilities will include project planning and operational delivery of clinical programs, and project management of the scope, schedule and budget. In addition to clinical work in drug projects, you may manage improvement or change projects in other business areas. You may be aligned to one or more projects depending on size and complexity and will be responsible to the Director Clinical Development for the program.

Your responsibilities will include: leading a cross functional team of clinical experts in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk; project management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans in agreed systems. You will provide input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols and will lead a large/complex work package or manage a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal or external partners. You will act as AZ operational interface with external partners for externally managed/outsourced studies as appropriate and will have responsibility for ensuring timely compliance with companywide governance

Requirements

Essential Requirements

  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
  • A minimum of 5 years’ experience from within the pharmaceutical industry or similar large multinational organization.
  • Extensive knowledge of clinical operations, project management tools and processes
  • Proven experience of clinical development / drug development process in various phases of development and therapy areas.
  • Proven ability to learn by working in multiple phases, TAs and/or different development situations.
  • Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
  • Must be able to work on-site. This will not be a remote working opportunity.

Desirable Requirements:

  • Project management certification
  • Knowledge of process improvement methodology such as Lean Sigma/Change Management
  • Experience in the oncology or immunology therapeutic area
  • Candidate from a local CRO is desirable.

Next Steps – Apply today!

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.