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 dis...
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 with key AstraZeneca partners as required.
Required Qualifications
Relevant Bachelor's degree with 10+ years of experience
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 cancer 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
Desirable Qualifications
Date Posted
22-May-2024
Closing Date
13-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.