Global Development Scientist Director, Heme
Company: AstraZeneca
Location: Gaithersburg
Posted on: May 16, 2022
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Job Description:
About AstraZenecaAstraZeneca is a global, science-led,
patient-focused biopharmaceutical company that focuses on the
discovery, development and commercialization of prescription
medicines for some of the world's most serious diseases. We are
more than one of the world's leading pharmaceutical
companies.AstraZeneca has a multifaceted environment that
cultivates collaboration and innovation. We attract top minds, and
we nurture and build talent.Hematology Research and Development,
Early and Late Development HematologyWithin Hematology R&D, we
are committed to advancing the science to deliver life-changing
medicines to patients most in need. With a combination-focused
pipeline that exploits the power of six scientific platforms
(Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage
Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics)
to help address unmet clinical needs in a host of hematological
cancers, we are motivated by a dedication to the scientific
discovery and collaboration that will one day help eliminate cancer
as a cause of death. This unit has responsibility for the value
chain from discovery through to late-stage development, enabling
rapid acceleration of promising early-stage assets and life-cycle
management programsROLE and RESPONSABILITIESThe Global Development
Scientist Director is an important part of the Clinical Project
Team (CPT), and Global Study Team (GST) working harmoniously and
cross functionally (in a matrix environment) with other CPT & GST
members, Site Management & Monitoring (SMM), field-based liaisons,
and site personnel. The Global Development Scientist Director and
counterpart Global Development Medical Director work
collaboratively in the clinical aspects underpinning a product.This
includes shared responsibility with Clinical Operations team
members in the planning and execution, including recruitment and
delivery of a clinical study. Accountabilities include clinical
support for the development and implementation of early and/or late
phase AstraZeneca sponsored clinical program strategies. As such,
you will provide scientific input into design & implementation of
clinical trial(s), their delivery, clinical data review and data
cleaning, interpretation of results, reporting successfully on
time, and activities required for worldwide registration of the
product (i.e. clinical input to NDA/BLA).The Global Development
Scientist Director may also provide expert input or lead functional
process improvement initiatives and provide contributions to
cross-asset or cross-tumor area working groups depending on the
level of experience.This position demands strong collaborative
communication skills, including the ability to engage with and
influence a diverse range of stakeholders both within and external
to AstraZeneca. The individual will operate according to the
highest ethical standards in compliance with internal SOPs, local
regulations, laws and adhere to Good Clinical Practice (GCP) and
regulatory requirements.Main duties:Work cross functionally within
CPT to ensure the clinical strategy is translated into the
development of the study concept document, study protocol and
related documentsProvide clinical/scientific input into design &
implementation of clinical trial(s), their delivery, clinical data
review and data cleaning, interpretation of results, reporting
successfully on time, and activities required for worldwide
registration of the product (i.e. clinical input to
NDA/BLA).Establish key relationships internally with clinical
project teams, and externally with regulatory bodies and external
service providers.Accountable for the relevance and accuracy of
clinical science underpinning of clinical study based on detailed
scientific review and consultation, for the clinical and scientific
leadership and integrity of protocols and/or components of clinical
plans and for the delivery of final protocol and its governance
approval.Lead the development of the protocol and related documents
and the development and delivery of the clinical study report to
meet GCP, ICH and all AstraZeneca quality standards.Lead cross
functional projects to ensure the successful passage of drugs
through all phases of the drug development process, or contribute
to one or more elements of such a project as a technical
expert.Review and interpret medical data and clinical trial data
and come up with conclusions with Medical DirectorYou will support
the development of clinical components of regulatory and EC/IRB
submission documents for instances where marketing approval is
warranted. Prepare and provide input to clinical study reports
(CSRs) and clinical portions of Regulatory Documents (e.g., IB,
DSUR, PSUR, regulatory responses)Participate or lead as needed the
review and assessment of new opportunities and ESRs.Responsible for
timely responses to investigational study sites for local ICF
changes, protocol & EC/IRB questions/requests.Contribute to
development and delivery of face to face or virtual investigator
and supervise training.Qualifications and Education RequirementsBS
required, PhD in a scientific field, PharmD or MD is strongly
preferredMinimum of 5 years of relevant experienceIndustry or
Academic experience in drug development required with experience in
malignant haematology clinical trials strongly preferred.Sufficient
technical knowledge (haemato-oncology background preferred) to be
able to interact with confidence with internal and external
partnerPossesses sound foundational knowledge of FDA and other
major country regulations and detailed knowledge of Good Clinical
Practice other regulations governing clinical research.Date
Posted22-Feb-2022Closing DateAstraZeneca 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.SummaryLocation: US -
Gaithersburg - MD; Canada - Mississauga; UK - Cambridge; US - South
San Francisco - CA; New York CityType: Full time
Keywords: AstraZeneca, Washington DC , Global Development Scientist Director, Heme, Executive , Gaithersburg, DC
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