Director Clinical Scientist, Oncology Cell Therapy
Location: Cambridgeshire, Gaithersburg, Maryland, South San Francisco, California, Waltham, Massachusetts
Job Type: Full time
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 cutting edge 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 the newly formed Astrazeneca’s Oncology Cell Unit and be part of building an innovative pipeline and deliver potentially high impact treatments to patients.
This position is an important part of the Global Project Team (GPT), working collaboratively with program and study level Clinical Lead/Study Physician as the specialist in 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.
You may also provide expert input to process improvement initiatives, development of junior members of growing Cell Therapy Clinical team and provide strategic contributions to the global Clinical Scientist team.
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 Gaithersburg, MD site, or alternatively in Waltham MA; San Francisco, CA; or our Cambridge UK site.
Typical Accountabilities (scope of the activity dependent on level of experience)
- You will support the Clinical Lead or may serve as Clinical Lead in clinical science aspects of the assigned Cell Therapy 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 (TSST) 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-CDIDcell therapy products
- Follows important developments and trends in the medical & scientific literature and disseminates updates to the GPT 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 advise the program strategy
Study Level (when assigned as clinical science resource for study):
- Supports the Clinical Lead/Study Physician or in some instances serve as the Clinical Lead for the study
- Guides aspects of the CDP and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product profile
- Leads (or supports as required) clinical data review and interpretation of the study and program level with input from the study or program Clinical Lead/Study Physician
- Attends (in person or by TC) the Site Initiation Visits, to present the study design and key aspects of the protocol
- Leads the compilation and interpretation of the data for and from the dose escalation committee/safety review committee, collaborating closely with the program physician
- Leads, approves or provides input for the protocols, amendments, and other relevant strategic documents. Acts as lead clinical reviewer for Clinical Study Reports
- Develops and builds investigator and site relationships to support site selection and study start up activities
- Leads the development & implementation of the ESCR strategy for a programme. Forms the link between the GPT and all external clinical research for the programme. 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.
- 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.
- Based on experience level, supervises and supports development of individuals within the team, including secondees and graduates
Education, Qualifications, Skills and Experience
- Relevant Clinical or Biomedical Ph.D. or relevant Pharmacy, Nursing, MSc/MRes degree
- Clinical drug development or medical research experience demonstrated (>5 years) within a pharmaceutical/biotech or academic environment
- Proven team leadership experience in a clinical setting (2-3 years)
- Advanced understanding of clinical practice across tumour types and how clinical practice is evolving with the introduction of new therapies.
- Understanding of T-cell biology and Cell & gene therapy.
- 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 and the ability to manage through conflict
- Proven track record 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 clinical and pharmaceutical drug development process
- Research or clinical experience in cell and gene therapy in an academic or industrial environment
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.
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 authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.