Jobs · Analyst · Maryland

Senior Group Director Scientist

AstraZeneca · Gaithersburg, MD · Yesterday
Analyst$234k–$350k/yrFull-time

People leadership

Line manages Clinical Scientists, including project allocation, resource management, recruitment, development, and performance management.

Skills leadership

Serves as Skills Lead for the Clinical Science group, ensuring appropriate procedures, training, development approaches, and best practices are in place.

Department leadership

Contributes to the Departmental Leadership Team by improving ways of working, identifying and resolving issues, setting departmental objectives, and supporting departmental resource planning and tracking.

Continuous improvement

Leads or contributes to continuous improvement initiatives.

Clinical leadership

As required, acts as Clinical Lead for a program or study, or provides senior support to the Clinical Lead.

Scientific integration

Leads or co-leads, with Translational and Bioscience Leads, the science-to-man sub-team (TSST) to integrate biological, translational, and clinical science into program strategy.

Study support

Provides scientific and medical guidance to study teams, including CRO partners.

Translational collaboration

Leads collaboration with research and translational scientists to provide clinical input into data generation and review supporting pre-CDID compounds.

External insight

Monitors relevant medical and scientific literature, sharing key developments and implications for program strategy with project teams and other stakeholders.

Publications

Leads development and review of publication content and quality, and contributes to publication strategy.

Competitive intelligence

Where required, leads project-specific competitor landscape reviews to inform program strategy.

Development planning

Guides the Clinical Development Plan and study protocols, ensuring alignment to the approved development strategy and target product profile.

Study start-up

Attends site initiation visits as needed to present study design and key protocol elements.

Data interpretation

Led or supports clinical data review and interpretation at study and program level, with input from the study or program Physician/Clinical Lead.

Governance support

Leads compilation and interpretation of data for dose-escalation and safety review committees, in collaboration with the program physician.

Documentation

Leads or oversees the authoring of protocols, amendments, Investigator Brochures, DSURs, and other key strategic documents, and acts as lead clinical reviewer for Clinical Study Reports.

Site and investigator engagement

Builds investigator and site relationships to support site selection and study start-up activities.

Business development support

Supports due diligence for potential in-licensing and collaborative opportunities, and provides recommendations to senior management.

External representation

Represents AstraZeneca in external meetings, including advisory boards, as needed.

Compliance

Operates in compliance with GCP and relevant regulatory guidelines.

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