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Clinical Scientist - GI (Edgewater)

Company: SRG Woolf
Location: Edgewater
Posted on: May 31, 2021

Job Description:

Clinical Scientist

Typical Accountabilities

The following tasks would be performed under the guidance of the clinical lead, 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 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 compounds
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 study lead 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

Supports development of investigator/site relationships to support site selection and study start up activities
Co-leads/supports the development and implementation of the externally sponsored collaborative research (ESCR) strategy for a program. The clinical scientist is the link between the project team 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 stakeholders as required.
Supports the physician/senior clinical scientist in representing the project internally and externally with key external experts. Supports development of alliances as appropriate.

Based on areas of expertise, supports development of individuals within the team, including secondees and graduates via a buddy system
Operates in compliance with GCP and relevant regulatory guidelines.

Education, Qualifications, Skills and Experience

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 the science of cancer, 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 ability in problem solving and issues management that is solution focused
Experience in collaborating externally

Relevant Clinical or Biomedical Ph.D
A good understanding of the clinical and pharmaceutical drug development process

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

Associated topics: biochemistry, bioengineering, bioinformatic, biological engineer, biology, biomedical, genetic, neurodegenerative, nutrition, parenteral

Keywords: SRG Woolf, Silver Spring , Clinical Scientist - GI (Edgewater), Other , Edgewater, Maryland

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