Director Scientist, Early Global Clinical Development – Oncology R&D

AstraZeneca is 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. But we’re more than one of the world’s leading pharmaceutical companies

As an Early Clinical Development Scientist, you are an important part of the Early Clinical Development team,, engaging around 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 can hire Clinical Scientists at Associate Director. Director, or Sr Director level, in our R&D sites at Waltham, MA or Gaithersburg, MD.

Roles and Responsibilities

• 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 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 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

• Strong preference for experience in the pharmaceutical industry specifically supporting early stage clinical drug development (phase 1-2 studies).