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Assoc. Director Clinical Development Scientist, Oncology R&D

Plats Gaithersburg, Maryland, USA Jobb-id R-065920 Datum inlagd 11/14/2019

At AstraZeneca, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As an Associate Director /Director Clinical Development Scientist – Oncology  in Gaithersburg, MD, or Granta Park, Cambridge UK, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative environment, as together we explore synergies between small and large molecules.

AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Main Duties and Responsibilities

This is a unique opportunity to join AstraZeneca at a time of tremendous growth and acceleration in the immune-oncology biologics portfolio. This is a fast-paced and dynamic work environment where the Clinical Scientist will assist in the design and execution of Oncology clinical programs. The Associate Director/Director, Clinical Scientist, you may serve in various roles including membership on clinical trial teams and clinical project sub-teams and may serve in leadership roles within these teams, and may be a representative on the Product Development Team (PDT). You will work in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development.  Additionally, you will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.

You will have a clear understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, the principles of translational medicine, and how to work effectively within cross-functional teams ensuring their success.  We are seeking a well-trained scientist/clinician with strong leadership skills who is driven by science and the desire to develop novel immuno-oncology therapies for cancer patients. You will have the opportunity for growth and development while working in a vibrant environment and "biotech" culture.

Responsibilities include:

The preparation of key product documentation to include to include protocols, the Clinical Development Plan, and regulatory submission documents as required.  Developing the key elements in of data review plans, along with performing medical data review during study execution as well as leading the collection and analysis of adverse events.   Operational support for clinical studies to include involvement in site selection, working with CROs and other 3rd party vendors regarding endpoints, participation in investigator meetings, study risk management, etc...  Internal and external collaborations.

Essential Requirements

For Associate Director, Clinical Development Scientist level:

  • PhD, PharmD, MD or Master's degree in health science field, or other relevant advanced degree in a health science field
  • At least 1-2 years of experience in clinical research and/or drug development in Oncology

For Director, Clinical Development Scientist level:

  • PhD, PharmD, MD or Master's degree in heath science field, or other relevant advanced degree in a health science field
  • Minimum two full years of experience in clinical research and/or oncology drug development in pharmaceutical or CRO environment.

Requirements for both levels:

  • Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology.
  • Excellent oral and written skills, strong interpersonal and listening skills
  • Results driven to achieve creative and sound outcomes
  • Proven leadership skills and demonstrated ability to interact collaboratively in a cross functional environment.
  • Ability to make sound and timely decisions; agile in learning and action oriented.
  • Ability to relate to colleagues and associates at all levels both inside and outside the organization.
  • Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.

Preferred Requirements

  • Immuno-oncology development experience
  • Experience in molecular oncology and/or translational science
  • Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams; experience managing and developing others
  • Ability to make sound and timely decisions; agile in learning and action oriented
  • High level of emotional intelligence; able to deal with ambiguity

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 authorisation and employment eligibility verification requirements.

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