Senior Group Director Scientist

Senior Group Director Scientist

Location:

Gaithersburg, MD (may consider other locations including Cambridge, MA, New York, NY, South San Francisco, CA)

The Senior Group Director Scientist is a senior leader within Hematology R&D, with responsibility for line management, development, and mentoring of clinical scientists. The role also serves on the departmental leadership team, contributing to resource planning, ways of working, and continuous improvement initiatives.

The role also includes senior clinical science leadership across Hematology programs, working collaboratively with program- and study-level physicians or clinical leads to provide expert input on the medical and scientific aspects of compound development. Accountabilities may include development and implementation of early- and late-phase clinical strategy, regulatory interactions and document authoring, interpretation of study results, and providing or supporting recommendations to senior management.

The role also provides strategic input to non-assigned programs, contributes to process improvement initiatives, supports development of clinical scientists within Hematology, and contributes to the broader global clinical scientist community.

As a key leadership member of the Global Project Team, 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.

• People leadership:
  Line manages Clinical Scientists, including project allocation, resource management, recruitment, development, and performance management.
• Skills leadership:
  May serve 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:
  Leads 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.

• Advanced degree:
  Master's degree required;
  PhD or equivalent preferred, in a scientific, medical, or health-related discipline.
• Experience:
  
  7+ years of relevant experience.

• Industry experience:
  Experience in clinical development and the broader biopharmaceutical industry.

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…