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Scientist, Early Clinical Development, Oncology R&d
4 months ago
**Are you a seasoned Early Clinical Scientist with experience in supporting Phase 1-2 studies? Do you have a keen interest in working across a variety of platforms such as IO, Antibody Drug Conjugates, Cell Therapy, Tumor Drivers and Resistance, Epigenetics and DNA Damage Response? **If so, AstraZeneca, home to one of the most promising Oncology pipelines in the industry, might be the perfect fit for you.
We are 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. Our bold ambition is to provide cures for cancer in every form. We are following the science to understand cancer and all its complexities to discover, develop and deliver life-changing treatments and increase the potential to save the lives of people around the world.
**Office Requirement**
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. This role will be based in our Gaithersburg MD or Waltham MA offices. We can not offer remote or alternative travel options.
**Typical accountabilities **(scope of the activity dependent on level of experience)
**Program Level (when assigned as clinical science resource for a program)**:
- Act as clinical lead or supports the clinical lead in clinical science aspects of the program
- Assists the clinical lead for clinical input to the clinical development plan (CDP) at all stages of the program
- Leads/co-leads/supports (with Translational and Bioscience Leads) the science-to-man sub team to integrate the biology, translational and clinical science into the program strategy
- Leads (or supports) development of recommendations on further development strategies to internal committees
- Leads (or supports, as required) the preparation of clinical and other data for governance and other presentations
- Leads (or support, as required) the preparation of program level documents such as the investigators brochure and DUSR.
- Provides scientific/medical mentorship (or coordinates) to the study team, including the CRO team
- Leads/supports the collaboration with the research scientists and translational scientists to provide clinical input to the development and review of data to support development of the pre-CDID compounds
- 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
- Leads or supports the development and review of content and quality of publications and inputs to development of the publication strategy
- Where required leads project specific reviews of the competitor landscape to inform the program strategy
**Study Level (when assigned as clinical science resource for a study)**:
- You will lead or support the study clinical lead
- Leads, approves or provides input for the protocols, amendments, and other relevant strategic documents. Acts as lead clinical reviewer for Clinical Study Reports
- Leads (or supports as required) clinical data review and interpretation of the study and program level with input from the study or program Physician/Clinical lead
- Attends (in person or by TC) the Site Initiation Visits, to present the study design and protocol
- Leads the compilation & interpretation of the data for and from the dose escalation committee/safety review committee, in collaboration with the program physician
**External Engagement**:
- Develops and builds investigator and site relationships to support site selection and study start up activities
- Leads 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. For preclinical external research proposals, co-leads with the Bioscience Lead.
- Leads investigator/site relationships for clinical proposal reviews, protocol review and approval, scientific oversight and discussions for academic basket/umbrella studies and ESCR studies
- Represents the project internally and supports oncology drug development externally as a medical scientific specialist with key external specialists. Supports development of alliances as appropriate.
- Represents AstraZeneca as a support for external meetings such as advisory boards and Investigator meetings
- Identifies and manages risks within the ESCR portfolio, raises quality issues through the appropriate channels, maintains communications
