Clinical Scientist - Early Oncology Clinical Development
Clinical Scientist, Early Oncology Clinical Development
Location: Gaithersburg MD, Waltham MA, or NY NY
Our ambition is to push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. To accomplish this, we focus on research and development and our commercial capabilities to deliver a new generation of medicines that have the potential to redefine cancer treatment.
The Oncology Research and Early Development (Early Oncology) unit has the accountability for all activities in small and large molecule oncology research up to the initiation of Phase 3 clinical studies. The unit seeks to deliver compelling preclinical, clinical and translational data packages providing confidence in the dosing strategy, tolerability profile and therapeutic efficacy of our candidate drugs to support investment in late stage clinical development.
As Clinical Scientist, you are an important part of the Project Team, working harmoniously with program and study level clinical lead/study physician as the specialist in medical scientific aspects of the compound 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 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.
You may also provide expert input to process improvement initiatives, development of junior members of the team and provide strategic contributions to the global clinical scientist team. We expect you to demonstrate strong collaborative communication skills and influence a diverse range of scientific partners both within and external to AstraZeneca.
We hire Clinical Scientists at various levels depending upon training and experience. Are you interested in working across a range of platforms such as IO, Antibody Drug Conjugates, Cell Therapy, Tumor Drivers and Resistance, Epigenetics and DNA Damage Response? This is your chance to work on one of the most promising Oncology pipelines in the industry!
- Act as clinical lead or support 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 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.
- 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 with key AstraZeneca partners as required.
Required Education, Skills and Experience:
- Relevant Clinical or Biomedical Ph.D. or relevant Pharmacy, Nursing, MSc/MRes degree.
- Clinical drug development or medical research experience demonstrated within a pharmaceutical/biotech or academic environment.
- Proven team leadership experience in a clinical setting.
- Advanced understanding of clinical practice across tumor types and how clinical practice is evolving with the introduction of new therapies. Understanding of cancel cell biology.
- Experience leading 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 in terms of clear requirements for collaborative contracts, influencing delivery and scientific engagement.
- Ability to support and mentor junior team members.
- A good understanding of the pharmaceutical industry.
- A good understanding of the clinical drug development process.
To be considered for this exciting opportunity, please apply now!
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.