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Senior Group Director, Clinical Scientist

AstraZeneca
Full-time
Remote friendly (Gaithersburg, MD)
United States
$221,500 - $332,250 USD yearly
Clinical Research and Development

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Role Summary

The Senior Group Director, Clinical Scientist will lead a group of clinical scientists within Hematology Research and Development and will serve as a member of the Clinical Development leadership team. You will lead a project and guide a team of clinical scientists, collaborating with program and study level physicians or clinical leads on medical and scientific aspects of the compound and its development. As a key Global Project Team member, you will engage with a diverse range of internal and external partners and contribute to the global clinical scientist team.

Responsibilities

  • Line manage other Clinical Scientists including project allocations/resource management, recruitment & selection, personal development and performance management
  • Serve as Skills Lead for the Clinical Science group, ensuring procedures, training and development approaches are in place and standard methodologies are identified and implemented
  • Contribute to the Departmental Leadership Team to ensure effective ways of working, issue resolution, objective setting, and departmental prioritization/supervision
  • Lead or contribute to continuous improvement initiatives and key alliances (provider and academic)
  • Lead or support clinical input to the clinical development plan at all stages of the program
  • Provide scientific/medical mentorship to the study team, including the CRO team
  • Monitor developments in medical/scientific literature and disseminate updates to the project team and beyond
  • Lead development and review of publications and inputs to the publication strategy
  • Guide aspects of the Clinical Development Plan (CDP) and Clinical Study Protocols, ensuring linkage of trial data to the target product profile
  • Attend Site Initiation Visits to present study design and protocol
  • Lead or support clinical data review and interpretation at study/program level with input from the study/program Physician/Clinical Lead
  • Own compilation and interpretation of data for dose escalation and safety reviews in collaboration with the program physician
  • Provide input for protocols, amendments, Investigator Brochure, DSURs and other strategic documents; act as lead clinical reviewer for Clinical Study Reports
  • Support due diligence for in-licensing or collaborations and provide recommendations to senior management
  • Drive key initiatives within and beyond the Hematology Clinical Development group
  • Develop, coach, mentor, motivate and encourage individuals
  • Ensure compliance with GCP and relevant regulatory guidelines

Qualifications

  • Advanced degree: PhD or PharmD with 12+ years of relevant industry experience and a proven track record in clinical development
  • Therapeutic expertise: Extensive knowledge of GCP and end-to-end drug development (Phases I–III), with preference for Hematology-Oncology
  • Global study leadership: Experience designing, organizing, and executing global clinical studies in pharma/biotech
  • Data and systems proficiency: Strong understanding of clinical data collection/reporting; proficient with data management systems and analytical tools
  • Clinical trial conduct: Experience managing and interpreting clinical trial results, including protocol development and writing
  • Scientific writing: Experience authoring protocols, study reports, publications
  • Analytical strength: Strong analytical and problem-solving skills
  • Matrix influence: Ability to work effectively in a matrixed environment and influence without direct authority
  • Execution under pressure: Ability to prioritize and deliver under tight deadlines while maintaining quality
  • Communication: Excellent English written and verbal communication; ability to convey complex information clearly
  • Stakeholder engagement: Knowledge to interact with internal and external partners
  • People leadership: Experience line managing, coaching and performance development
  • Language: High proficiency in English (written and spoken)

Education

  • PhD or PharmD required
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