AstraZeneca

Clinical Scientist, Oncology Cell Therapy

6 days left

Location
Massachusetts, USA, Waltham
Salary
Negotiable
Posted
11 Feb 2021
Closes
11 Mar 2021
Ref
R-100316
Contact
AstraZeneca
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Clinical Scientist, Oncology Cell Therapy Competitive salary and benefits

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 outstanding skills with those of people from all over the globe!

AstraZeneca's is a leader in Oncology with a global footprint and ability to deliver best in class medicines both small and large molecules to the market. With the new leadership under the unified Oncology R&D, the company has prioritized to invest in groundbreaking technology. One area of significant investment is to build internal infrastructure to be a leader in next generation cellular therapy products in Oncology. Using historical expertise in biologics engineering, gene editing and immune expertise across solid and heme malignancies, Astrazeneca is uniquely positioned to develop the best technologies for cellular therapies and is already growing a differentiated pipeline. Backed by senior leadership, the newly formed Oncology Cell Unit will utilize the best expertise within Astrazeneca while allowing for the rapid expansion of cellular therapy research and development.

Join Astrazeneca's Oncology Cell Unit and be part of building an innovative pipeline and deliver potentially high impact treatments to patients.

The Clinical Scientist - Cell Therapy is an important member of the Global Project Team (GPT), working under the supervision of a Clinical Lead/Study Physician or Senior Clinical Scientist, supporting activities related to the medical scientific aspects of the cell therapy product and its development. The accountabilities are broad, however, the core accountabilities are the medical & scientific support for the development and implementation of early phase AstraZeneca-sponsored clinical program strategy, externally sponsored collaborative research (ESCR) program strategy and studies, including clinical science support for initiating clinical trial(s), supporting clinical data review, interpretation of the study results and supporting final recommendations to senior management.

As a key member of the GPT, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of partners both within and external to AstraZeneca.

In this role, you can be based in our Waltham, MA site, or alternatively in Gaithersburg, MD, New York city, or our Cambridge UK site.

Typical Accountabilities:

The following tasks would be performed under the mentorship of the Clinical Lead, Study Physician or a senior member of the Clinical Scientist team, with the expectation that over time the Clinical Scientist would become function more independently.

Program Level:
  • Assists with the clinical input to the clinical development plan at all stages of the assigned Cell Therapy program
  • Supports the science-to-man sub team (TSST) to integrate the biology, translational and clinical science into the program strategy
  • Supports in developing recommendation(s) on further development strategies to internal committees
  • Supports the preparation of clinical and other data for governance and other presentations
  • Supports the preparation of program level documents such as the investigators brochure and DUSR
  • Follows important developments and trends in the medical & scientific literature and disseminates updates to the project team and beyond ensuring all involved parties are aware of key developments and the impact on the strategy, with physician or senior clinical scientist support
  • Supports the collaboration with the Lead Bio-scientist and Translational scientist to provide clinical input to the development and review of data for input to the development of pre-CDID cell therapy products
  • Supports the development and review of content and quality of publications and inputs to development of the publication strategy

Study Level (when assigned as clinical science resource for study):

  • The Clinical Scientist will support the Clinical Lead/Study Physician or in some instances serve as the Clinical Lead for the study
  • Supports aspects of the Clinical Development Plan (CDP) and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product profile
  • Supports with clinical data review and interpretation at the study and program level with input from the study or program physician
  • Supports the compilation and interpretation of the data for and from the dose escalation committee/safety review committee, in collaboration with the program physician
  • Supports the preparation of clinical and other data for governance and other presentations
  • Supports medical and scientific input to specific studies as required by the program Clinical Lead/Study Physician
  • Supports updates for the protocols, amendments, and other relevant strategic documents. Supports the review of the Clinical Study Report
External:
  • Supports development of investigator/site relationships to support site selection and study start up activities
  • Co-leads/supports the development and implementation of the ESCR strategy for a program. The Clinical Scientist is the link between the GPT and all external clinical research for the program
  • Co-leads/Supports investigator and site relationships for clinical proposal reviews, protocol review and approval, scientific oversight and discussions for academic basket/umbrella study and ESCR studies
  • Identifies and manages risks within the ESCR portfolio, raises quality issues through the appropriate channels, maintains communications with key AstraZeneca partners as required
  • Supports the physician/senior clinical scientist in representing the project internally and externally with key external specialists. Supports development of alliances as appropriate
Education, Qualifications, Skills and Experience

Essential

  • Relevant Clinical or Biomedical M.Sc. or relevant Pharmacy, Nursing, MSc/MRes degree
  • Clinical drug development or medical research experience demonstrated (> 2 years) within a pharmaceutical/biotech or academic environment
  • Basic knowledge of clinical oncology practice and T-cell biology, with the ability to rapidly acquire knowledge
  • Experience supporting delivery and influencing at senior leadership levels both internally and externally
  • Experience in working and leading in matrix teams
  • Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and manage through conflict
  • Proven track record in problem solving and issues management that is solution focused
  • Experience in collaborating externally, influencing delivery and scientific engagement.
Desirable
  • Ph.D in a relevant subject area
  • A good understanding of the clinical and pharmaceutical drug development process
  • Research or clinical experience in cell and gene therapy in a pharmaceutical/biotech or academic environment
Benefits:

AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, and offers valuable choices.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential.

Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together.

This role is advertised from February 11th until March 10th.

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