Director Scientist Early Oncology Global Development – AstraZeneca – Waltham, MA

Role Description – Director Scientist Early Oncology Global Development

The Director Scientist Early Oncology is an important part of the Project Team, working synergistically with the program and study level physician or clinical lead as the expert 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 providing/supporting final recommendations to senior management.

The Director Scientist also drives and provides expert input to other non-assigned clinical programs, process improvement initiatives, development of junior members of the team and drives and provides strategic contributions to the global clinical scientist team.

As a leadership member of the Global Development , this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca.

This role can be based in Gaithersburg MD, Waltham MA or NYC NY in the USA, or Cambridge in the UK.

Typical Accountabilities

Program Level:

• As required, the Director Scientist can act as Clinical Lead for the program/study or support the clinical lead
• Leads or supports clinical input to the clinical development plan at all stages of the program
• Leads or co-lead (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/supports development of recommendation(s) on further development strategies to internal committees
• Leads (or supports, as required) the preparation of clinical and other data for governance and other presentations
• Provide scientific/medical guidance to the study team, including the CRO team
• Leads 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 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 and as required based on team resources assigned):

• As required, the Director Scientist can act as Clinical Lead for the AZ sponsored study
• Guides aspects of the Clinical Development Plan (CDP) and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product profile
• Attends (in person or by TC) the Site Initiation Visits, to present the study design and key aspects of the protocol
• 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
• Leads the compilation and interpretation of the data for and from the dose escalation committee/safety review committee, in collaboration with the program physician
• Leads, approves or provides input for the protocols, amendments, Investigator Brochure, DSURs and other relevant strategic documents. Acts as lead clinical reviewer for Clinical Study Reports

External:

• 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 ESCR clinical proposal reviews, protocol review and approval, scientific oversight and discussions for academic basket/umbrella and ESCR studies
• Represents the project internally and supports oncology drug development externally as a medical scientific expert with key external collaborators and supports development of alliances as appropriate
• Support due diligence activities for potential in-licensing or collaborative opportunities and provides recommendations to senior management
• 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 stakeholders as required

Other

• Drives key strategic initiatives within and beyond the Early Oncology Global Clinical Development group
• Develops, coaches, mentors, motivates and inspires individuals within the organization
• Operates in compliance with GCP and relevant regulatory guidelines.

Essential Education Requirements:

• Relevant Clinical or Biomedical Ph.D. or relevant Pharmacy, Nursing, MSc/MRes degree

Essential Qualifications, Skills and Experience:

• Extensive (> 6 years) clinical drug development or medical experience demonstrated within a pharmaceutical/biotech environment
• Proven team leadership experience in a clinical setting (> 2 years)
• Understanding of tumor biology, and mechanism of drug tumor target interaction
• Comprehensive knowledge of the clinical and pharmaceutical drug development process in oncology
• Proven experience leading delivery and influencing at senior leadership levels both internally and externally
• Experience and strength 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
• Ability/willingness to lead strategic and/ operational management of a compound program should the need arise
• Experience in collaborating externally in terms of clear requirements for collaborative contracts, influencing delivery and scientific engagement.
• Demonstrated ability to support and mentor junior or new team members

Preferred Qualifications, Skills and Experience:

• People management
• Recognised field specialist/Subject Matter Expert
• Cell Therapy experience/focus

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